WO2026009167A1 - A manufacturing process for albumin involving a heating step - Google Patents

Abstract

The present disclosure relates to an improved method of heating a fraction V or equivalent fraction thereof comprising albumin.

Description

A MANUFACTURING PROCESS RELATED APPLICATION DATA The present application claims priority from European Patent Application No. 24186027.9 filed on 2 July 2024 entitled “A Manufacturing Process”. The entire contents of which is hereby incorporated by reference. FIELD The present disclosure relates to an improved method of heating a fraction V or equivalent fraction thereof comprising albumin. BACKGROUND Serum albumin is the most abundant circulating protein found in plasma and represents half of the total protein content of plasma in healthy individuals. In humans, serum albumin plays a major role in maintaining the osmotic pressure of blood, as well as in the transport of endogenous and exogenous ligands (i.e., drugs) in the bloodstream. Albumin has a long plasma half-life of approximately 19 days, which has led to the use of albumin to extend the half-life of pharmaceutical compounds. For example, albumin has been fused to human coagulation Factor IX (FIX) resulting in extended half-life of FIX (IDELVION®). Albumin has also been conjugated to chemotherapeutic compounds (such as paclitaxel) to increase drug half-life and drug accumulation (e.g., Abraxane®). Additionally, albumin solutions (e.g., Albumex® and Alburex®) have demonstrated clinical benefits as intravenous fluid therapy in clinical settings such as liver disease, sepsis, intensive care, and surgery. Further applications in research consist of cell culture supplement, drug delivery carrier and protein/drug stabiliser. As a result, the demand for human albumin is continually increasing. For all plasma-derived therapeutic products, there is a potential risk of contamination from pathogens, including relevant blood-borne viruses, emerging viruses, and prion proteins. To minimise the risk of transmissible infections, the production of human albumin solutions includes pathogen removal and inactivation methods, such as, fractionation and pasteurisation. However, one of the major problems of existing albumin manufacturing processes (i.e., of a fraction V or equivalent fraction thereof) is the lengthy processing times. It will therefore be apparent to the skilled person that there is an ongoing need in the art for methods with reduced processing times and that do not impact the purity and/or yield of the final albumin solution. SUMMARY The present disclosure is based on the inventors’ identification of an improved method of producing purified albumin solutions. Specifically, the present disclosure is based on the inventors’ surprising finding that incorporating a heat treatment step after purification using an ethanol fractionation process, and prior to an optional pasteurisation step, advantageously reduces the processing time required to produce a purified albumin solution that meets the appropriate pharmacopoeia standards such as, European Pharmacopoeia (Ph. Eur), United States Pharmacopeia (USP) and Chinese Pharmacopoeia. Accordingly, the findings by the inventors provide the basis for methods of heat treating and/or reducing proteolytic activity of a fraction V or equivalent fraction thereof comprising albumin. It will be apparent to the skilled person that albumin (e.g., fraction V or an equivalent fraction thereof) is derived from plasma or plasma fractions thereof during an ethanol fractionation process. For example, the present disclosure provides a method of heat treating and/or reducing proteolytic activity of a fraction comprising albumin, wherein the fraction V or equivalent fraction thereof is derived from plasma or a plasma fraction thereof. The present disclosure also provides a method of heat treating a fraction V or equivalent fraction thereof comprising albumin, the method comprising heating the fraction V at a temperature of between about 70°C to about 74°C for a period of between 30 seconds to 30 minutes, thereby producing a heat treated albumin solution. The present disclosure also provides a method of heat treating a fraction V or equivalent fraction thereof comprising albumin, the method comprising heating the fraction V or equivalent fraction thereof at a temperature of between 70°C ± 0.2°C to 74°C ± 0.2°C for a period of between 30 seconds to 30 minutes, thereby producing a heat treated albumin solution. The present disclosure also provides a method of heat treating a fraction V or equivalent fraction thereof comprising albumin, the method comprising one or more rounds of heating the fraction V or equivalent fraction thereof at a temperature of between about 70°C to about 74°C for a period of between 30 seconds to 30 minutes, thereby producing a heat treated albumin solution. The present disclosure also provides a method of heat treating a fraction V or equivalent fraction thereof comprising albumin, the method comprising one or more rounds of heating the fraction V or equivalent fraction thereof at a temperature of between 70°C ± 0.2°C to 74°C ± 0.2°C for a period of between 30 seconds to 30 minutes, thereby producing a heat treated albumin solution. The present disclosure also provides a method of heat treating a fraction V or equivalent fraction thereof comprising albumin, the method comprising one or more rounds of heating the fraction V or equivalent fraction thereof at a temperature of between about 70°C to about 74°C for a period of between 30 seconds to 30 minutes, one or more rounds of clarifying the fraction V or equivalent fraction thereof after heating the fraction V or equivalent fraction thereof, thereby producing a heat treated albumin solution. The present disclosure also provides a method of heat treating a fraction V or equivalent fraction thereof comprising albumin, the method comprising one or more rounds of heating the fraction V or equivalent fraction thereof at a temperature of between 70°C ± 0.2°C to 74°C ± 0.2°C for a period of between 30 seconds to 30 minutes, one or more rounds of clarifying the fraction V or equivalent fraction thereof after heating the fraction V or equivalent fraction thereof, thereby producing a heat treated albumin solution. The present disclosure also provides a method of heat treating a fraction V or equivalent fraction thereof comprising albumin, the method comprising one or more rounds of heating the fraction at a temperature of: i) between 70°C ± 0.2°C to 71°C ± 0.2°C for a period of between 1 to 30 minutes; ii) 72°C ± 0.2°C and for a period of between 1 to 20 minutes; ii) 72.5°C ± 0.2°C and for a period of between 1 to 12 minutes; iii) 73°C ± 0.2°C and for a period of between 1 to 3 minutes; or iv) 74°C ± 0.2°C and for a period of 50 seconds, and one or more rounds of clarifying the fraction V or equivalent fraction thereof after heating the fraction V or equivalent fraction thereof, thereby producing a heat treated albumin solution. The present disclosure further provides a method of reducing proteolytic activity of a fraction V or equivalent fraction thereof comprising albumin, the method comprising heating the fraction V or equivalent fraction thereof at a temperature of between about 70°C to about 74°C for a period of between 30 seconds to 30 minutes, thereby producing an albumin solution with reduced proteolytic activity. The present disclosure further provides a method of reducing proteolytic activity of a fraction V or equivalent fraction thereof comprising albumin, the method comprising heating the fraction V or equivalent fraction thereof at a temperature of between 70°C ± 0.2°C to 74°C ± 0.2°C for a period of between 30 seconds to 30 minutes, thereby producing an albumin solution with reduced proteolytic activity. The present disclosure further provides a method of reducing proteolytic activity of a fraction V or equivalent fraction thereof comprising albumin, the method comprising one or more rounds of heating the fraction V or equivalent fraction thereof at a temperature of between about 70°C to about 74°C for a period of between 30 seconds to 30 minutes, thereby producing an albumin solution with reduced proteolytic activity. The present disclosure further provides a method of reducing proteolytic activity of a fraction V or equivalent fraction thereof comprising albumin, the method comprising one or more rounds of heating the fraction V or equivalent fraction thereof at a temperature of between 70°C ± 0.2°C to 74°C ± 0.2°C for a period of between 30 seconds to 30 minutes, thereby producing an albumin solution with reduced proteolytic activity. The present disclosure further provides a method of reducing proteolytic activity of a fraction V or equivalent fraction thereof comprising albumin, the method comprising one or more rounds of heating the fraction V or equivalent fraction thereof at a temperature of between about 70°C to about 74°C for a period of between 30 seconds to 30 minutes, one or more rounds of clarifying the fraction V or equivalent fraction thereof after heating the fraction V or equivalent fraction thereof, thereby producing an albumin solution with reduced proteolytic activity. The present disclosure further provides a method of reducing proteolytic activity of a fraction V or equivalent fraction thereof comprising albumin, the method comprising one or more rounds of heating the fraction V or equivalent fraction thereof at a temperature of between 70°C ± 0.2°C to 74°C ± 0.2°C for a period of between 30 seconds to 30 minutes, one or more rounds of clarifying the fraction V or equivalent fraction thereof after heating the fraction V or equivalent fraction thereof, thereby producing an albumin solution with reduced proteolytic activity. The present disclosure also provides a method of reducing proteolytic activity of a fraction V or equivalent fraction thereof comprising albumin, the method comprising one or more rounds of heating the fraction V or equivalent fraction thereof at a temperature of: i) between 70°C ± 0.2°C to 71°C ± 0.2°C for a period of between 1 to 30 minutes; ii) 72°C ± 0.2°C and for a period of between 1 to 20 minutes; ii) 72.5°C ± 0.2°C and for a period of between 1 to 12 minutes; iii) 73°C ± 0.2°C and for a period of between 1 to 3 minutes; or iv) 74°C ± 0.2°C and for a period of 50 seconds, and one or more rounds of clarifying the fraction V or equivalent fraction thereof after heating the fraction V or equivalent fraction thereof, thereby producing an albumin solution with reduced proteolytic activity. In one example, the temperature is between 69.8°C and 74°C. For example, the temperature is between 69.8°C and 70.2°C. In one example, the temperature is between 69.9°C and 70.3°C. In one example, the temperature is between 70°C and 70.4°C. In one example, the temperature is between 70.1°C and 70.5°C. In one example, the temperature is between 70.2°C and 70.6°C. In one example, the temperature is between 70.3°C and 70.7°C. In one example, the temperature is between 70.4°C and 70.8°C. In one example, the temperature is between 70.5°C and 70.9°C. In one example, the temperature is between 70.6°C and 71.0°C. In one example, the temperature is between 70.7°C and 71.1°C. In one example, the temperature is between 70.8°C and 71.2°C. In one example, the temperature is between 70.9°C and 71.3°C. In one example, the temperature is between 71°C and 71.4°C. In one example, the temperature is between 71.1°C and 71.5°C. In one example, the temperature is between 71.2°C and 71.6°C. In one example, the temperature is between 71.3°C and 71.7°C. In one example, the temperature is between 71.4°C and 71.8°C. In one example, the temperature is between 71.5°C and 71.9°C. In one example, the temperature is between 71.6°C and 72°C. In one example, the temperature is between 71.7°C and 72.1°C. In one example, the temperature is between 71.8°C and 72.2°C. In one example, the temperature is between 71.9°C and 72.3°C. In one example, the temperature is between 72°C and 72.4°C. In one example, the temperature is between 72.1°C and 72.5°C. In one example, the temperature is between 72.2°C and 72.6°C. In one example, the temperature is between 72.3°C and 72.7°C. In one example, the temperature is between 72.4°C and 72.8°C. In one example, the temperature is between 72.5°C and 72.9°C. In one example, the temperature is between 72.6°C and 73°C. In one example, the temperature is between 72.7°C and 73.1°C. In one example, the temperature is between 72.8°C and 73.2°C. In one example, the temperature is between 72.9°C and 73.3°C. In one example, the temperature is between 73°C and 73.4°C. In one example, the temperature is between 73.1°C and 73.5°C. In one example, the temperature is between 73.2°C and 73.6°C. In one example, the temperature is between 73.3°C and 73.7°C. In one example, the temperature is between 73.4°C and 73.8°C. In one example, the temperature is between 73.5°C and 73.9°C. In one example, the temperature is between 73.6°C and 74°C. In one example, the temperature is 69.8°C. In one example, the temperature is 69.9°C. In one example, the temperature is 70°C. In one example, the temperature is 70.1°C. In one example, the temperature is 70.2°C. In one example, the temperature is 70.3°C. In one example, the temperature is 70.4°C. In one example, the temperature is 70.5°C. In one example, the temperature is 70.6°C. In one example, the temperature is 70.7°C. In one example, the temperature is 70.8°C. In one example, the temperature is 70.9°C. In one example, the temperature is 71°C. In one example, the temperature is 71.1°C. In one example, the temperature is 71.2°C. In one example, the temperature is 71.3°C. In one example, the temperature 71.4°C. In one example, the temperature is 71.5°C. In one example, the temperature is 71.6°C. In one example, the temperature is 71.7°C. In one example, the temperature 71.8°C. In one example, the temperature is 71.9°C. In one example, the temperature is 72°C. In one example, the temperature is 72.1°C. In one example, the temperature is 72.2°C. In one example, the temperature is 72.3°C. In one example, the temperature 72.4°C. In one example, the temperature is 72.5°C. In one example, the temperature is 72.6°C. In one example, the temperature is 72.7°C. In one example, the temperature 72.8°C. In one example, the temperature is 72.9°C. In one example, the temperature is 73°C. In one example, the temperature is 73.1°C. In one example, the temperature is 73.2°C. In one example, the temperature is 73.3°C. In one example, the temperature 73.4°C. In one example, the temperature is 73.5°C. In one example, the temperature is 73.6°C. In one example, the temperature is 73.7°C. In one example, the temperature is 73.8°C. In one example, the temperature is 73.9°C. In one example, the temperature is 74°C. In one example, the period is between 30 seconds to 30 minutes. For example, the period is between 1 to 30 minutes. In one example, the period is between 1 to 20 minutes. In one example, the period is between 10 to 20 minutes. In one example, the period is between 10 to 30 minutes. In one example, the period is between 20 to 30 minutes. In one example, the period is between 1 to 15 minutes. In one example, the period is between 1 to 12 minutes. In one example, the period is between 1 to 10 minutes. In one example, the period is between 1 to 8 minutes. In one example, the period is between 1 to 5 minutes. In one example, the period is between 1 to 4 minutes. In one example, the period is between 1 to 3 minutes. In one example, the period is between 1 to 2 minutes. In one example, the period is 30 seconds. In one example, the period is 35 seconds. In one example, the period is 40 seconds. In one example, the period is 45 seconds. In one example, the period is 50 seconds. In one example, the period is 55 seconds. In one example, the period is 1 minute. In one example, the period is 1.5 minutes (i.e., 1 minute and 30 seconds). In one example, the period is 2 minutes. In one example, the period is 2.5 minutes. In one example, the period is 3 minutes. In one example, the period is 3.5 minutes. In one example, the period is 4 minutes. In one example, the period is 4.5 minutes. In one example, the period is 5 minutes. In one example, the period is 5.5 minutes. In one example, the period is 6 minutes. In one example, the period is 6.5 minutes. In one example, the period is 7 minutes. In one example, the period is 7.5 minutes. In one example, the period is 8 minutes. In one example, the period is 8.5 minutes. In one example, the period is 9 minutes. In one example, the period is 9.5 minutes. In one example, the period is 10 minutes. In one example, the period is 10.5 minutes. In one example, the period is 11 minutes. In one example, the period is 11.5 minutes. In one example, the period is 12 minutes. In one example, the period is 12.5 minutes. In one example, the period is 13 minutes. In one example, the period is 13.5 minutes. In one example, the period is 14 minutes. In one example, the period is 14.5 minutes. In one example, the period is 15 minutes. In one example, the period is 15.5 minutes. In one example, the period is 16 minutes. In one example, the period is 16.5 minutes. In one example, the period is 17 minutes. In one example, the period is 17.5 minutes. In one example, the period is 18 minutes. In one example, the period is 18.5 minutes. In one example, the period is 19 minutes. In one example, the period is 19.5 minutes. In one example, the period is 20 minutes. In one example, the period is 20.5 minutes. In one example, the period is 21 minutes. In one example, the period is 21.5 minutes. In one example, the period is 22 minutes. In one example, the period is 22.5 minutes. In one example, the period is 23 minutes. In one example, the period is 23.5 minutes. In one example, the period is 24 minutes. In one example, the period is 24.5 minutes. In one example, the period is 25 minutes. In one example, the period is 25.5 minutes. In one example, the period is 26 minutes. In one example, the period is 26.5 minutes. In one example, the period is 27 minutes. In one example, the period is 27.5 minutes. In one example, the period is 28 minutes. In one example, the period is 28.5 minutes. In one example, the period is 29 minutes. In one example, the period is 29.5 minutes. In one example, the period is 30 minutes. In one example, the temperature is between about 70°C to about 71°C and the period is between 1 to 30 minutes. In one example, the temperature is between 70°C ± 0.2°C to 71°C ± 0.2°C and the period is between 1 to 30 minutes. In one example, the temperature is between 69.8°C to 71.2°C and the period is between 1 to 30 minutes. In one example, the temperature is between 70°C to 71°C and the period is between 1 to 30 minutes. In one example, the temperature is between 69.8°C and 70.2°C and the period is between 1 to 30 minutes. In one example, the temperature is between 69.9°C and 70.3°C and the period is between 1 to 30 minutes. In one example, the temperature is between 70°C and 70.4°C and the period is between 1 to 30 minutes. In one example, the temperature is between 70.1°C and 70.5°C and the period is between 1 to 30 minutes. In one example, the temperature is between 70.2°C and 70.6°C and the period is between 1 to 30 minutes. In one example, the temperature is between 70.3°C and 70.7°C and the period is between 1 to 30 minutes. In one example, the temperature is between 70.4°C and 70.8°C and the period is between 1 to 30 minutes. In one example, the temperature is between 70.5°C and 70.9°C and the period is between 1 to 30 minutes. In one example, the temperature is between 70.6°C and 71°C and the period is between 1 to 30 minutes. In one example, the temperature is between 70.7°C and 71.1°C and the period is between 1 to 30 minutes. In one example, the temperature is between 70.8°C and 71.2°C and the period is between 1 to 30 minutes. In one example, the temperature is 69.8°C and the period is between 1 to 30 minutes. In one example, the temperature is 69.9°C and the period is between 1 to 30 minutes. In one example, the temperature is 70°C and the period is between 1 to 30 minutes. In one example, the temperature is 70.1°C and the period is between 1 to 30 minutes. In one example, the temperature is 70.2°C and the period between 1 to 30 minutes. In one example, the temperature is 70.3°C and the period between 1 to 30 minutes. In one example, the temperature is 70.4°C and the period between 1 to 30 minutes. In one example, the temperature is 70.5°C and the period between 1 to 30 minutes. In one example, the temperature is 70.6°C and the period between 1 to 30 minutes. In one example, the temperature is 70.7°C and the period between 1 to 30 minutes. In one example, the temperature is 70.8°C and the period between 1 to 30 minutes. In one example, the temperature is 70.9°C and the period is between 1 to 30 minutes. In one example, the temperature is 71°C and the period is between 1 to 30 minutes. In one example, the temperature is between 69.8°C to 71.2°C and the period is between 10 to 30 minutes. In one example, the temperature is between 70°C to 71°C and the period is between 10 to 30 minutes. In one example, the temperature is between 69.8°C and 70.2°C and the period is between 10 to 30 minutes. In one example, the temperature is between 69.9°C and 70.3°C and the period is between 10 to 30 minutes. In one example, the temperature is between 70°C and 70.4°C and the period is between 10 to 30 minutes. In one example, the temperature is between 70.1°C and 70.5°C and the period is between 10 to 30 minutes. In one example, the temperature is between 70.2°C and 70.6°C and the period is between 10 to 30 minutes. In one example, the temperature is between 70.3°C and 70.7°C and the period is between 10 to 30 minutes. In one example, the temperature is between 70.4°C and 70.8°C and the period is between 10 to 30 minutes. In one example, the temperature is between 70.5°C and 70.9°C and the period is between 10 to 30 minutes. In one example, the temperature is between 70.6°C and 71°C and the period is between 10 to 30 minutes. In one example, the temperature is between 70.7°C and 71.1°C and the period is between 10 to 30 minutes. In one example, the temperature is between 70.8°C and 71.2°C and the period is between 10 to 30 minutes. In one example, the temperature is 69.8°C and the period is between 10 to 30 minutes. In one example, the temperature is 69.9°C and the period is between 10 to 30 minutes. In one example, the temperature is 70°C and the period is between 10 to 30 minutes. In one example, the temperature is 70.1°C and the period is between 10 to 30 minutes. In one example, the temperature is 70.2°C and the period is between 10 to 30 minutes. In one example, the temperature is 70.3°C and the period is between 10 to 30 minutes. In one example, the temperature is 70.4°C and the period is between 10 to 30 minutes. In one example, the temperature is 70.5°C and the period is between 10 to 30 minutes. In one example, the temperature is 70.6°C and the period is between 10 to 30 minutes. In one example, the temperature is 70.7°C and the period is between 10 to 30 minutes. In one example, the temperature is 70.8°C and the period is between 10 to 30 minutes. In one example, the temperature is 70.9°C and the period is between 10 to 30 minutes. In one example, the temperature is 71°C and the period is between 10 to 30 minutes. In one example, the temperature is between 69.8°C to 71.2°C and the period is between 20 to 30 minutes. In one example, the temperature is between 70°C to 71°C and the period is between 20 to 30 minutes. In one example, the temperature is between 69.8°C and 70.2°C and the period is between 20 to 30 minutes. In one example, the temperature is between 69.9°C and 70.3°C and the period is between 20 to 30 minutes. In one example, the temperature is between 70°C and 70.4°C and the period is between 20 to 30 minutes. In one example, the temperature is between 70.1°C and 70.5°C and the period is between 20 to 30 minutes. In one example, the temperature is between 70.2°C and 70.6°C and the period is between 20 to 30 minutes. In one example, the temperature is between 70.3°C and 70.7°C and the period is between 20 to 30 minutes. In one example, the temperature is between 70.4°C and 70.8°C and the period is between 20 to 30 minutes. In one example, the temperature is between 70.5°C and 70.9°C and the period is between 20 to 30 minutes. In one example, the temperature is between 70.6°C and 71°C and the period is between 20 to 30 minutes. In one example, the temperature is between 70.7°C and 71.1°C and the period is between 20 to 30 minutes. In one example, the temperature is between 70.8°C and 71.2°C and the period is between 20 to 30 minutes. In one example, the temperature is 69.8°C and the period is between 20 to 30 minutes. In one example, the temperature is 69.9°C and the period is between 20 to 30 minutes. In one example, the temperature is 70°C and the period is between 20 to 30 minutes. In one example, the temperature is 70.1°C and the period is between 20 to 30 minutes. In one example, the temperature is 70.2°C and the period is between 30 minutes. In one example, the temperature is 70.3°C and the period is between 30 minutes. In one example, the temperature is 70.4°C and the period is between 30 minutes. In one example, the temperature is 70.5°C and the period is between 30 minutes. In one example, the temperature is 70.6°C and the period is between 30 minutes. In one example, the temperature is 70.7°C and the period is between 30 minutes. In one example, the temperature is 70.8°C and the period is between 30 minutes. In one example, the temperature is 70.9°C and the period is between 30 minutes. In one example, the temperature is 71°C and the period is between 20 to 30 minutes. In one example, the temperature is between 69.8°C to 71.2°C and the period is between 20.5 to 27.5 minutes. In one example, the temperature is between 69.8°C to 71°C and the period is between 20.5 to 27.5 minutes. In one example, the temperature is between 69.8°C and 70.2°C and the period is between 20.5 to 27.5 minutes. In one example, the temperature is between 69.9°C and 70.3°C and the period is between 20.5 to 27.5 minutes. In one example, the temperature is between 70°C to 71°C and the period is between 20.5 to 27.5 minutes. In one example, the temperature is between 70°C and 70.4°C and the period is between 20.5 to 27.5 minutes. In one example, the temperature is between 70.1°C and 70.5°C and the period is between 20.5 to 27.5 minutes. In one example, the temperature is between 70.2°C and 70.6°C and the period is between 20.5 to 27.5 minutes. In one example, the temperature is between 70.3°C and 70.7°C and the period is between 20.5 to 27.5 minutes. In one example, the temperature is between 70.4°C and 70.8°C and the period is between 20.5 to 27.5 minutes. In one example, the temperature is between 70.5°C and 70.9°C and the period is between 20.5 to 27.5 minutes. In one example, the temperature is between 70.6°C and 71°C and the period is between 20.5 to 27.5 minutes. In one example, the temperature is between 70.7°C and 71.1°C and the period is between 20.5 to 27.5 minutes. In one example, the temperature is between 70.8°C and 71.2°C and the period is between 20.5 to 27.5 minutes. In one example, the temperature is 69.8°C and the period is between 20.5 to 27.5 minutes. In one example, the temperature is 69.9°C and the period is between 20.5 to 27.5 minutes. In one example, the temperature is 70°C and the period is between 20.5 to 27.5 minutes. In one example, the temperature is 70.1°C and the period is between 20.5 to 27.5 minutes. In one example, the temperature is 70.2°C and the period is between 20.5 to 27.5 minutes. In one example, the temperature is 70.3°C and the period is between 20.5 to 27.5 minutes. In one example, the temperature is 70.4°C and the period is between 20.5 to 27.5 minutes. In one example, the temperature is 70.5°C and the period is between 20.5 to 27.5 minutes. In one example, the temperature is 70.6°C and the period is between 20.5 to 27.5 minutes. In one example, the temperature is 70.7°C and the period is between 20.5 to 27.5 minutes. In one example, the temperature is 70.8°C and the period is between 20.5 to 27.5 minutes. In one example, the temperature is 70.9°C and the period is between 20.5 to 27.5 minutes. In one example, the temperature is 71°C and the period is between 20.5 to 27.5 minutes. In one example, the temperature is between 69.8°C to 70.2°C and the period is 20.5 minutes. In one example, the temperature is 69.8°C and the period is 20.5 minutes. In one example, the temperature is 69.9°C and the period is 20.5 minutes. In one example, the temperature is 70°C and the period is 20.5 minutes. In one example, the temperature is 70.1°C and the period is 20.5 minutes. In one example, the temperature is 70.2°C and the period is 20.5 minutes. In one example, the temperature is between 69.8°C to 70.2°C and the period is 21 minutes. In one example, the temperature is 69.8°C and the period is 21 minutes. In one example, the temperature is 69.9°C and the period is 21 minutes. In one example, the temperature is 70°C and the period is 21 minutes. In one example, the temperature is 70.1°C and the period is 21 minutes. In one example, the temperature is 70.2°C and the period is 21 minutes. In one example, the temperature is between 69.8°C to 70.2°C and the period is 22 minutes. In one example, the temperature is 69.8°C and the period is 22 minutes. In one example, the temperature is 69.9°C and the period is 22 minutes. In one example, the temperature is 70°C and the period is 22 minutes. In one example, the temperature is 70.1°C and the period is 22 minutes. In one example, the temperature is 70.2°C and the period is 22 minutes. In one example, the temperature is between 69.8°C to 70.2°C and the period is 23 minutes. In one example, the temperature is 69.8°C and the period is 23 minutes. In one example, the temperature is 69.9°C and the period is 23 minutes. In one example, the temperature is 70°C and the period is 23 minutes. In one example, the temperature is 70.1°C and the period is 23 minutes. In one example, the temperature is 70.2°C and the period is 23 minutes. In one example, the temperature is between 69.8°C to 70.2°C and the period is 24 minutes. In one example, the temperature is 69.8°C and the period is 24 minutes. In one example, the temperature is 69.9°C and the period is 24 minutes. In one example, the temperature is 70°C and the period is 24 minutes. In one example, the temperature is 70.1°C and the period is 24 minutes. In one example, the temperature is 70.2°C and the period is 24 minutes. In one example, the temperature is between 69.8°C to 70.2°C and the period is 25 minutes. In one example, the temperature is 69.8°C and the period is 25 minutes. In one example, the temperature is 69.9°C and the period is 25 minutes. In one example, the temperature is 70°C and the period is 25 minutes. In one example, the temperature is 70.1°C and the period is 25 minutes. In one example, the temperature is 70.2°C and the period is 25 minutes. In one example, the temperature is between 69.8°C to 70.2°C and the period is 26 minutes. In one example, the temperature is 69.8°C and the period is 26 minutes. In one example, the temperature is 69.9°C and the period is 26 minutes. In one example, the temperature is 70°C and the period is 26 minutes. In one example, the temperature is 70.1°C and the period is 26 minutes. In one example, the temperature is 70.2°C and the period is 26 minutes. In one example, the temperature is between 69.8°C to 70.2°C and the period is 27 minutes. In one example, the temperature is 69.8°C and the period is 27 minutes. In one example, the temperature is 69.9°C and the period is 27 minutes. In one example, the temperature is 70°C and the period is 27 minutes. In one example, the temperature is 70.1°C and the period is 27 minutes. In one example, the temperature is 70.2°C and the period is 27 minutes. In one example, the temperature is between 69.8°C to 70.2°C and the period is 27.5 minutes. In one example, the temperature is 69.8°C and the period is 27.5 minutes. In one example, the temperature is 69.9°C and the period is 27.5 minutes. In one example, the temperature is 70°C and the period is 27.5 minutes. In one example, the temperature is 70.1°C and the period is 27.5 minutes. In one example, the temperature is 70.2°C and the period is 27.5 minutes. In one example, the temperature is about 72°C and the period is between 1 to 20 minutes. In one example, the temperature is 72°C ± 0.2°C and the period is between 1 to 20 minutes. In one example, the temperature is 72°C and the period is between 1 to 20 minutes. In one example, the temperature is 72°C and the period is between 10 to 20 minutes. In one example, the temperature is 72°C and the period is between 1 to 15 minutes. In one example, the temperature is 72°C and the period is between 1 to 10 minutes. In one example, the temperature is 72°C and the period is between 1 to 5 minutes. In one example, the temperature is 72°C and the period is 1 minute. In one example, the temperature is 72°C and the period is 2 minutes. In one example, the temperature is 72°C and the period is 3 minutes. In one example, the temperature is 72°C and the period is 4 minutes. In one example, the temperature is 72°C and the period is 5 minutes. In one example, the temperature is about 72.5°C and the period is between 1 to 12 minutes. In one example, the temperature is 72.5°C ± 0.2°C and the period is between 1 to 12 minutes. In one example, the temperature is 72.5°C and the period is between 1 to 12 minutes. In one example, the temperature is 72.5°C and the period is between 1 to 10 minutes. In one example, the temperature is 72.5°C and the period is between 1 to 8 minutes. In one example, the temperature is 72.5°C and the period is between 1 to 5 minutes. In one example, the temperature is 72.5°C and the period is between 1 to 3 minutes. In one example, the temperature is 72.5°C and the period is 1 minute. In one example, the temperature is 72.5°C and the period is 2 minutes. In one example, the temperature is 72.5°C and the period is 3 minutes. In one example, the temperature is 72.5°C and the period is 4 minutes. In one example, the temperature is 72.5°C and the period is 5 minutes. In one example, the temperature is 72.5°C and the period is 6 minutes. In one example, the temperature is 72.5°C and the period is 7 minutes. In one example, the temperature is 72.5°C and the period is 8 minutes. In one example, the temperature is 72.5°C and the period is 9 minutes. In one example, the temperature is 72.5°C and the period is 10 minutes. In one example, the temperature is 72.5°C and the period is 11 minutes. In one example, the temperature is 72.5°C and the period is 12 minutes. In one example, the temperature is about 73°C and the period is between 1 to 3 minutes. In one example, the temperature is 73°C ± 0.2°C and the period is between 1 to 3 minutes. In one example, the temperature is 73°C and the period is between 1 to 3 minutes. In one example, the temperature is 73°C and the period is between 1 to 2 minutes. In one example, the temperature is 73°C and the period is 1 minute. In one example, the temperature is 73°C and the period is 2 minutes. In one example, the temperature is 73°C and the period is 3 minutes. In one example, the temperature is about 74°C and the period is between 30 to 50 seconds. In one example, the temperature is 74°C ± 0.2°C and the period is between 30 to 50 seconds. In one example, the temperature is 74°C and the period is between 30 to 50 seconds. In one example, the temperature is 74°C and the period is 30 seconds. In one example, the temperature is 74°C and the period is 35 seconds. In one example, the temperature is 74°C and the period is 40 seconds. In one example, the temperature is 74°C and the period is 45 seconds. In one example, the temperature is 74°C and the period is 50 seconds. In one example, the method comprises multiple rounds of heating the fraction V or equivalent fraction thereof. For example, the method comprises at least one round of heating the fraction V or equivalent fraction thereof. In one example, the method comprises at least three rounds of heating the fraction V or equivalent fraction thereof. In one example, the method comprises at least four rounds of heating the fraction V or equivalent fraction thereof. In one example, the method comprises at least five rounds of heating the fraction V or equivalent fraction thereof. In one example, the fraction V or equivalent fraction thereof comprises a purity of at least 95% albumin. For example, the fraction V or equivalent fraction thereof comprises a purity of 95%, or 96%, or 97%, or 98%, or 99%, or 100% albumin. In one example, the fraction V or equivalent fraction thereof comprises a purity of at least 95% albumin. In one example, the fraction V or equivalent fraction thereof comprises a purity of at least 96% albumin. In one example, the fraction V or equivalent fraction thereof comprises a purity of at least 97% albumin. In one example, the fraction V or equivalent fraction thereof comprises a purity of at least 98% albumin. In one example, the fraction V or equivalent fraction thereof comprises a purity of at least 99% albumin. In one example, the fraction V or equivalent fraction thereof comprises a purity of 100% albumin. In one example, the fraction V or equivalent fraction thereof comprises a purity of at least 95% albumin and less than 5% impurities. In one example, the fraction V or equivalent fraction thereof comprises a purity of at least 96% albumin and less than 4% impurities. In one example, the fraction V or equivalent fraction thereof comprises a purity of at least 97% albumin and less than 3% impurities. In one example, the fraction V or equivalent fraction thereof comprises a purity of at least 98% albumin and less than 2% impurities. In one example, the fraction V or equivalent fraction thereof comprises a purity of at least 99% albumin and less than 1% impurities. In one example, the fraction V or equivalent fraction thereof comprises a purity of 100% albumin and no impurities. In one example, the albumin solution (e.g., the heat treated albumin solution and/or the albumin solution with reduced proteolytic activity) comprises a purity of at least 95% albumin. For example, the albumin solution comprises a purity of 95%, or 96%, or 97%, or 98%, or 99%, or 100% albumin. In one example, the albumin solution comprises a purity of at least 96% albumin. In one example, the albumin solution comprises a purity of at least 97% albumin. In one example, the albumin solution comprises a purity of at least 98% albumin. In one example, the albumin solution comprises a purity of at least 99% albumin. In one example, the albumin solution comprises a purity of 100% albumin. In one example, the albumin solution comprises a purity of at least 95% albumin and less than 5% impurities. In one example, the albumin solution comprises a purity of at least 96% albumin and less than 4% impurities. In one example, the albumin solution comprises a purity of at least 97% albumin and less than 3% impurities. In one example, the albumin solution comprises a purity of at least 98% albumin and less than 2% impurities. In one example, the albumin solution comprises a purity of at least 99% albumin and less than 1% impurities. In one example, the albumin solution comprises a purity of at least 100% albumin and no impurities. Methods of determining the purity of the albumin solution and/or fraction V or equivalent fraction thereof will be apparent to the skilled person and/or described herein. In one example, the purity of the albumin present in the albumin solution and/or the purity of the albumin present in the fraction V or equivalent fraction thereof is assessed using one or more of the following: acetate cellulose electrophoresis, sodium dodecyl-sulfate polyacrylamide gel electrophoresis (SDS-PAGE), agarose gel electrophoresis, matrix-assisted laser desorption/ionization-time of flight (MALDI-TOF) mass spectrometry (MS) peptide fingerprint analysis, liquid chromatography mass spectrometry (LC-MS), reversed-phase high- performance liquid chromatography (RP-HPLC), high performance liquid size exclusion chromatography (HPLC-SEC), capillary electrophoresis sodium dodecyl sulfate (CE-SDS), and nephelometry. In one example, the purity of the albumin is assessed using acetate cellulose electrophoresis. In one example, the purity of the albumin is assessed using SDS-PAGE. In one example, the purity of the albumin is assessed using agarose gel electrophoresis. In one example, the purity of the albumin is assessed using MALDI-TOF-MS peptide fingerprint analysis. In one example, the purity of the albumin is assessed using LC-MS. In one example, the purity of the albumin is assessed using RP-HPLC. In one example, the purity of the albumin is assessed using CE-SDS. In one example, the purity of the albumin is assessed using HPLC- SEC techniques. In one example, the purity of the albumin is assessed using nephelometry. In one example, the albumin solution (e.g., the heat treated albumin solution and/or the albumin solution with reduced proteolytic activity) comprises at least 85% albumin monomer. For example, the albumin solution comprises 85%, or 86% or, 87%, or 88%, or 89%, or 90%, or 91%, or 92%, or 93%, or 94%, or 95%, or 96%, or 97%, or 98%, or 99%, or 100% albumin monomer. In one example, the albumin solution comprises at least 86% albumin monomer. In one example, the albumin solution comprises at least 87% albumin monomer. In one example, the albumin solution comprises at least 88% albumin monomer. In one example, the albumin solution comprises at least 89% albumin monomer. In one example, the albumin solution comprises at least 90% albumin monomer. In one example, the albumin solution comprises at least 91% albumin monomer. In one example, the albumin solution comprises at least 92% albumin monomer. In one example, the albumin solution comprises at least 93% albumin monomer. In one example, the albumin solution comprises at least 94% albumin monomer. In one example, the albumin solution comprises at least 95% albumin monomer. In one example, the albumin solution comprises at least 96% albumin monomer. In one example, the albumin solution comprises at least 97% albumin monomer. In one example, the albumin solution comprises at least 98% albumin monomer. In one example, the albumin solution comprises at least 99% albumin monomer. In one example, the albumin solution comprises 100% albumin monomer. In one example, the fraction V or equivalent fraction thereof comprises at least 85% albumin monomer. For example, the fraction V or equivalent fraction thereof comprises 85%, or 86% or, 87%, or 88%, or 89%, or 90%, or 91%, or 92%, or 93%, or 94%, or 95%, or 96%, or 97%, or 98%, or 99%, or 100% albumin monomer. In one example, the fraction V or equivalent fraction thereof comprises at least 86% albumin monomer. In one example, the fraction V or equivalent fraction thereof comprises at least 87% albumin monomer. In one example, the fraction V or equivalent fraction thereof comprises at least 88% albumin monomer. In one example, the fraction V or equivalent fraction thereof comprises at least 89% albumin monomer. In one example, the fraction V or equivalent fraction thereof comprises at least 90% albumin monomer. In one example, the fraction V or equivalent fraction thereof comprises at least 91% albumin monomer. In one example, the fraction V or equivalent fraction thereof comprises at least 92% albumin monomer. In one example, the fraction V or equivalent fraction thereof comprises at least 93% albumin monomer. In one example, the fraction V or equivalent fraction thereof comprises at least 94% albumin monomer. In one example, the fraction V or equivalent fraction thereof comprises at least 95% albumin monomer. In one example, the fraction V or equivalent fraction thereof comprises at least 96% albumin monomer. In one example, the fraction V or equivalent fraction thereof comprises at least 97% albumin monomer. In one example, the fraction V or equivalent fraction thereof comprises at least 98% albumin monomer. In one example, the fraction V or equivalent fraction thereof comprises at least 99% albumin monomer. In one example, the fraction V or equivalent fraction thereof comprises 100% albumin monomer. In one example, the albumin solution (e.g., the heat treated albumin solution and/or the albumin solution with reduced proteolytic activity) comprises less than 5% albumin aggregate. For example, the albumin solution comprises less than 5%, or 4%, or 3%, or 2%, or 1%, or 0.5% albumin aggregate. In one example, the albumin solution comprises less than 5% albumin aggregate. In one example, the albumin solution comprises less than 4% albumin aggregate. In one example, the albumin solution comprises less than 3% albumin aggregate. In one example, the albumin solution comprises less than 2% albumin aggregate. In one example, the albumin solution comprises less than 1% albumin aggregate. In one example, the albumin solution comprises less than 0.5% albumin aggregate. For example, the albumin solution (e.g., the heat treated albumin solution and/or the albumin solution with reduced proteolytic activity) comprises less than 5% albumin aggregate according to the European Pharmacopoeia (Ph. Eur). For example, the albumin solution comprises less than 5%, or 4%, or 3%, or 2%, or 1%, or 0.5% albumin aggregate according to the European Pharmacopoeia (Ph. Eur). In one example, the albumin solution comprises less than 5% albumin aggregate according to the European Pharmacopoeia (Ph. Eur). In one example, the albumin solution comprises less than 4% albumin aggregate according to the European Pharmacopoeia (Ph. Eur). In one example, the albumin solution comprises less than 3% albumin aggregate according to the European Pharmacopoeia (Ph. Eur). In one example, the albumin solution comprises less than 2% albumin aggregate according to the European Pharmacopoeia (Ph. Eur). In one example, the albumin solution comprises less than 1% albumin aggregate according to the European Pharmacopoeia (Ph. Eur). In one example, the albumin solution comprises less than 0.5% albumin aggregate according to the European Pharmacopoeia (Ph. Eur). In one example, the fraction V or equivalent fraction thereof comprises less than 5% albumin aggregate. For example, the fraction V or equivalent fraction thereof comprises less than 5%, or 4%, or 3%, or 2%, or 1%, or 0.5% albumin aggregate. In one example, the fraction V or equivalent fraction thereof comprises less than 5% albumin aggregate. In one example, the fraction V or equivalent fraction thereof comprises less than 4% albumin aggregate. In one example, the fraction V or equivalent fraction thereof comprises less than 3% albumin aggregate. In one example, the fraction V or equivalent fraction thereof comprises less than 2% albumin aggregate. In one example, the fraction V or equivalent fraction thereof comprises less than 1% albumin aggregate. In one example, the fraction V or equivalent fraction thereof comprises less than 0.5% albumin aggregate. For example, the fraction V or equivalent fraction thereof comprises less than 5% albumin aggregate according to the European Pharmacopoeia (Ph. Eur). For example, the fraction V or equivalent fraction thereof comprises less than 5%, or 4%, or 3%, or 2%, or 1%, or 0.5% albumin aggregate according to the European Pharmacopoeia (Ph. Eur). In one example, the fraction V or equivalent fraction thereof comprises less than 5% albumin aggregate according to the European Pharmacopoeia (Ph. Eur). In one example, the fraction V or equivalent fraction thereof comprises less than 4% albumin aggregate according to the European Pharmacopoeia (Ph. Eur). In one example, the fraction V or equivalent fraction thereof comprises less than 3% albumin aggregate according to the European Pharmacopoeia (Ph. Eur). In one example, the fraction V or equivalent fraction thereof comprises less than 2% albumin aggregate according to the European Pharmacopoeia (Ph. Eur). In one example, the fraction V or equivalent fraction thereof comprises less than 1% albumin aggregate according to the European Pharmacopoeia (Ph. Eur). In one example, the fraction V or equivalent fraction thereof comprises less than 0.5% albumin aggregate according to the European Pharmacopoeia (Ph. Eur). Methods of determining the percentage of the albumin monomer and/or the percentage of the albumin aggregates in the albumin solution and/or in the fraction V or equivalent fraction thereof will be apparent to the skilled person and/or described herein. In one example, the percentage of the albumin monomer and/or the percentage of the albumin aggregate is determined using size-exclusion chromatography (SEC). In one example, the percentage of the albumin monomer is determined using SEC. In one example, the percentage of the albumin aggregate is determined using SEC. In one example, the albumin solution (e.g., the heat treated albumin solution and/or the albumin solution with reduced proteolytic activity) has a turbidity of less than 0.5, 0.4, 0.3, 0.2 or 0.1 optical density at 320 nm (OD₃₂₀). In one example, the albumin solution has a turbidity of less than 0.5 OD₃₂₀. In one example, the albumin solution has a turbidity of less than 0.4 OD₃₂₀. In one example, the albumin solution has a turbidity of less than 0.3 OD₃₂₀. In one example, the albumin solution has a turbidity of less than 0.2 OD₃₂₀. In one example, the albumin solution has a turbidity of less than 0.1 OD₃₂₀. In one example, the turbidity is determined using an optical absorbance detector (e.g., Photometer Evolution 220, Thermo Scientific). In one example, wavelength is measured at 320 nm. In one example, the albumin solution (e.g., the heat treated albumin solution and/or the albumin solution with reduced proteolytic activity) has a proteolytic activity of less than 2, 1.5, 1.0 or 0.5 milli optical density at 405 nm per minute (mOD₄₀₅/min). In one example, the albumin solution has a proteolytic activity of less than 2 mOD₄₀₅/min. In one example, the albumin solution has a proteolytic activity of less than 1.9 mOD₄₀₅/min. In one example, the albumin solution has a proteolytic activity of less than 1.8 mOD₄₀₅/min. In one example, the albumin solution has a proteolytic activity of less than 1.7 mOD₄₀₅/min. In one example, the albumin solution has a proteolytic activity of less than 1.6 mOD₄₀₅/min. In one example, the albumin solution has a proteolytic activity of less than 1.5 mOD₄₀₅/min. In one example, the albumin solution has a proteolytic activity of less than 1.4 mOD₄₀₅/min. In one example, the albumin solution has a proteolytic activity of less than 1.3 mOD₄₀₅/min. In one example, the albumin solution has a proteolytic activity of less than 1.2 mOD₄₀₅/min. In one example, the albumin solution has a proteolytic activity of less than 1.1 mOD₄₀₅/min. In one example, the albumin solution has a proteolytic activity of less than 1 mOD₄₀₅/min. In one example, the albumin solution has a proteolytic activity of less than 0.9 mOD₄₀₅/min. In one example, the albumin solution has a proteolytic activity of less than 0.8 mOD₄₀₅/min. In one example, the albumin solution has a proteolytic activity of less than 0.7 mOD₄₀₅/min. In one example, the albumin solution has a proteolytic activity of less than 0.6 mOD₄₀₅/min. In one example, the albumin solution has a proteolytic activity of less than 0.5 mOD₄₀₅/min. In one example, the albumin solution has a proteolytic activity of less than 0.4 mOD₄₀₅/min. In one example, the albumin solution has a proteolytic activity of less than 0.3 mOD₄₀₅/min. In one example, the albumin solution has a proteolytic activity of less than 0.2 mOD₄₀₅/min. In one example, the albumin solution has a proteolytic activity of less than 0.1 mOD₄₀₅/min. Methods of determining the proteolytic activity of a fraction V or equivalent fraction thereof comprising albumin or an albumin solution (e.g., the heat treated albumin solution and/or the albumin solution with reduced proteolytic activity) will be apparent to the skilled person and/or described herein. For example, it will be understood that methods of determining the proteolytic activity of a fraction V or equivalent fraction thereof comprising albumin or albumin solution will be dependent on the method (e.g., assay kit or plate reader), the sample matrix (e.g. presence of protease inhibitors), and the parameters used (e.g., buffer composition, incubation time and temperature), and as well as the dilution of the sample. In one example, the proteolytic activity is determined using an assay kit selected from the group consisting of a thrombin activity assay kit, a general serine protease assay kit, a kallikrein activity assay kit, a plasmin activity assay kit, a FXa activity kit, and combinations thereof. In one example, the proteolytic activity is determined using a Plate Reader GloMax Discover (Promega). For example, the proteolytic activity is measured at 405 nm. In one example, the proteolytic activity is determined using a thrombin activity assay kit comprising a chromogenic substrate. In one example, the proteolytic activity is determined using a general serine protease assay kit comprising a chromogenic substrate. In one example, the proteolytic activity is determined using a kallikrein activity assay kit comprising a chromogenic substrate. In one example, the proteolytic activity is determined using a plasmin activity assay kit comprising a chromogenic substrate. In one example, the proteolytic activity is determined using a FXa activity kit comprising a chromogenic substrate. For example, the proteolytic activity is determined using a thrombin activity assay kit comprising chromogenic substrate S-2238. In one example, the proteolytic activity is determined using a general serine protease assay kit comprising chromogenic substrate S-2288. In one example, the proteolytic activity is determined using a kallikrein activity assay kit comprising chromogenic substrate S-2302. In one example, the proteolytic activity is determined using a plasmin activity assay kit comprising chromogenic substrate S-2251. In one example, the proteolytic activity is determined using a FXa activity kit comprising chromogenic substrate S-2765. The skilled person will recognise a suitable fraction V or equivalent fraction thereof comprising albumin for use in a method of the disclosure. In one example, the fraction V or equivalent fraction thereof has been subjected to one or more steps selected from a group consisting of ion exchange chromatography, viral inactivation, viral filtration, ultrafiltration/diafiltration and combinations thereof. An exemplary fraction V or equivalent fraction thereof comprising albumin includes albumin of human or animal origin or other original sources or fractions thereof. In one example, the fraction V or equivalent fraction thereof is derived from a plasma or plasma fraction thereof. For example, the fraction V or equivalent fraction thereof is derived from cryo- rich plasma, cryo-poor plasma, partially purified plasma solution, partially purified cryo-poor plasma solution and combinations thereof. In one example, the ethanol fractionation process is the Cohn purification fractionation process or variation thereof. In another example, the ethanol fractionation process is the Kistler/Nitschmann purification fractionation process or variation thereof. In one example, the fraction V comprising albumin is a Cohn Fraction V (Fr V) or equivalent fraction thereof. In one example, the equivalent fraction thereof is a Kistler/Nitschmann Precipitate C Fraction (KN C). In one example, the equivalent fraction thereof is a fraction V obtained from cold-ethanol fractionation of plasma or plasma fraction thereof. In one example, the equivalent fraction thereof is a suspension, filtrate or concentrate thereof. For example of a suspension, filtrate or concentrate of Precipitate C or of Fraction V may be referred to herein as Filtrate D. In one example, the equivalent fraction thereof is filtrate D. In one example, the fraction V or equivalent fraction thereof comprising albumin is selected from the group consisting of a mammalian fraction V or equivalent fraction thereof, a human fraction V or equivalent fraction thereof, an equine fraction V or equivalent fraction thereof, and a bovine fraction V or equivalent fraction thereof. In one example, the fraction V or equivalent fraction thereof is a mammalian fraction V or equivalent fraction thereof. In one example, the fraction V or equivalent fraction thereof is a human fraction V or equivalent fraction thereof. In one example, the fraction V or equivalent fraction thereof is an equine fraction V or equivalent fraction thereof. In one example, the fraction V or equivalent fraction thereof is a bovine fraction V or equivalent fraction thereof. In one example, the albumin is mammalian serum albumin. In one example, the albumin is human serum albumin. In another example, the albumin is bovine serum albumin. In another example, the albumin is equine serum albumin. In one example, the fraction V or equivalent fraction thereof is thawed at room temperature. In one example, the fraction V or equivalent fraction thereof does not comprise a detectable amount of ethanol. In one example, the fraction V or equivalent fraction thereof comprises a detectable amount of ethanol. For example, the fraction V or equivalent fraction thereof is from Cohn Fraction V (Fr V). During Cohn fractionation ethanol is added to the plasma in stages to form precipitate. In one example, the Fr V is precipitated using ethanol. For example, the Fr V is precipitated using about 40% ethanol. In one example, the Fr V comprises residual ethanol. In one example, the Fr V comprises maximum 15% v/v ethanol. In one example, the Fr V does not comprise a detectable amount of ethanol. In another example, the fraction V or equivalent fraction thereof is Kistler/Nitschmann Precipitate C (KN C). During Kistler/Nitschmann fractionation ethanol is added to the plasma in stages to form precipitate. In one example, the KN C is precipitated using ethanol. For example, the KN C is precipitated using about 40% ethanol. In one example, the KN C comprises residual ethanol. In one example, the KN C comprises maximum 15% v/v ethanol. In one example, the KN C does not comprise a detectable amount of ethanol. In one example, the fraction V or equivalent fraction thereof comprises between 40 g/L to 260 g/L of albumin. In one example, the fraction V or equivalent fraction thereof comprises between 40 g/L to 60 g/L of albumin. In one example, the fraction V or equivalent fraction thereof comprises between 190 g/L to 210 g/L of albumin. In one example, the fraction V or equivalent fraction thereof comprises between 240 g/L to 260 g/L of albumin. In one example, the fraction V or equivalent fraction thereof comprises 40 g/L of albumin. In one example, the fraction V or equivalent fraction thereof comprises 50 g/L of albumin. In one example, the fraction V or equivalent fraction thereof comprises 60 g/L of albumin. In one example, the fraction V or equivalent fraction thereof comprises 190 g/L of albumin. In one example, the fraction V or equivalent fraction thereof comprises 200 g/L of albumin. In one example, the fraction V or equivalent fraction thereof comprises 210 g/L of albumin. In one example, the fraction V or equivalent fraction thereof comprises 240 g/L of albumin. In one example, the fraction V or equivalent fraction thereof comprises 250 g/L of albumin. In one example, the fraction V or equivalent fraction thereof comprises 260 g/L of albumin. In one example, the fraction V or equivalent fraction thereof comprises at least one stabiliser. In one example, the at least one stabiliser is added to the fraction V or equivalent fraction thereof prior to heating the fraction V or equivalent fraction thereof. For example, the stabiliser is sodium caprylate or N-acetyl-DL-tryptophan. In some examples, the fraction V or equivalent fraction thereof comprises sodium caprylate and N-acetyl-DL-tryptophan. In some examples, the sodium caprylate is added to the fraction V or equivalent fraction thereof prior to heating the fraction V or equivalent fraction thereof. In some examples, the sodium caprylate is added to the fraction V or equivalent fraction thereof prior to heating the fraction V or equivalent fraction thereof, wherein the fraction V or equivalent fraction thereof already comprises sodium caprylate. In one example, the fraction V or equivalent fraction thereof comprises at least 0.07 mmol per gram of total protein of the stabiliser. In one example, the fraction V or equivalent fraction thereof comprises 0.07 mmol per gram of total protein of the stabiliser. In one example, the fraction V or equivalent fraction thereof comprises 0.08 mmol per gram of total protein of the stabiliser. In one example, the fraction V or equivalent fraction thereof comprises 0.09 mmol per gram of total protein of the stabiliser. In one example, the fraction V or equivalent fraction thereof comprises 0.10 mmol per gram of total protein of the stabiliser. In another example, the fraction V or equivalent fraction thereof comprises at least 0.16 mmol per gram of total protein of the stabiliser. In one example, the fraction V or equivalent fraction thereof comprises 0.16 mmol per gram of total protein of the stabiliser. In one example, the fraction V or equivalent fraction thereof comprises 0.07 mmol per gram of total protein of sodium caprylate and 0.07 mmol per gram of total protein of N-acetyl-DL-tryptophan. In one example, the fraction V or equivalent fraction thereof comprises 0.07 mmol per gram of total protein of sodium caprylate and 0.08 mmol per gram of total protein of N-acetyl-DL-tryptophan. In one example, the fraction V or equivalent fraction thereof comprises 0.07 mmol per gram of total protein of sodium caprylate and 0.09 mmol per gram of total protein of N-acetyl-DL- tryptophan. In one example, the fraction V or equivalent fraction thereof comprises 0.08 mmol per gram of total protein of sodium caprylate and 0.07 mmol per gram of total protein of N- acetyl-DL-tryptophan. In one example, the fraction V or equivalent fraction thereof comprises 0.08 mmol per gram of total protein of sodium caprylate and 0.08 mmol per gram of total protein of N-acetyl-DL-tryptophan. In one example, the fraction V or equivalent fraction thereof comprises 0.08 mmol per gram of total protein of sodium caprylate and 0.09 mmol per gram of total protein of N-acetyl-DL-tryptophan. In one example, the fraction V or equivalent fraction thereof comprises 0.09 mmol per gram of total protein of sodium caprylate and 0.07 mmol per gram of total protein of N-acetyl-DL-tryptophan. In one example, the fraction V or equivalent fraction thereof comprises 0.09 mmol per gram of total protein of sodium caprylate and 0.08 mmol per gram of total protein of N-acetyl-DL-tryptophan. In one example, the fraction V or equivalent fraction thereof comprises 0.09 mmol per gram of total protein of sodium caprylate and 0.09 mmol per gram of total protein of N-acetyl-DL-tryptophan. In one example, the fraction V or equivalent fraction thereof comprises 0.10 mmol per gram of total protein of sodium caprylate and 0.07 mmol per gram of total protein of N-acetyl-DL- tryptophan. In one example, the fraction V or equivalent fraction thereof comprises 0.10 mmol per gram of total protein of sodium caprylate and 0.08 mmol per gram of total protein of N- acetyl-DL-tryptophan. In one example, the fraction V or equivalent fraction thereof comprises 0.10 mmol per gram of total protein of sodium caprylate and 0.09 mmol per gram of total protein of N-acetyl-DL-tryptophan. In one example, the fraction V or equivalent fraction thereof comprises 0.16 mmol per gram of total protein of sodium caprylate. In one example, the fraction V or equivalent fraction thereof comprises 50 g/L of albumin, 0.08 mmol per gram of total protein of sodium caprylate and 0.08 mmol per gram of total protein of N-acetyl-DL-tryptophan. In one example, the fraction V or equivalent fraction thereof comprises 200 g/L of albumin, 0.08 mmol per gram of total protein of sodium caprylate and 0.08 mmol per gram of total protein of N-acetyl-DL-tryptophan. In one example, the fraction V or equivalent fraction thereof comprises 250 g/L of albumin, 0.08 mmol per gram of total protein of sodium caprylate and 0.08 mmol per gram of total protein of N-acetyl-DL-tryptophan. In one example, the fraction V or equivalent fraction thereof has a pH of between 6 and 7.5. In one example, the fraction V or equivalent fraction thereof has a pH of between 6.5 and 7.5. In one example, the fraction V or equivalent fraction thereof has a pH of between 6.7 and 7.3. In one example, the fraction V or equivalent fraction thereof has a pH of 6.0. In one example, the fraction V or equivalent fraction thereof has a pH of 6.1. In one example, the fraction V or equivalent fraction thereof has a pH of 6.2. In one example, the fraction V or equivalent fraction thereof has a pH of 6.3. In one example, the fraction V or equivalent fraction thereof has a pH of 6.4. In one example, the fraction V or equivalent fraction thereof has a pH of 6.5. In one example, the fraction V or equivalent fraction thereof has a pH of 6.6. In one example, the fraction V or equivalent fraction thereof has a pH of 6.7. In one example, the fraction V or equivalent fraction thereof has a pH of 6.8. In one example, the fraction V or equivalent fraction thereof has a pH of 6.9. In one example, the fraction V or equivalent fraction thereof has a pH of 7.0. In one example, the fraction V or equivalent fraction thereof has a pH of 7.1. In one example, the fraction V or equivalent fraction thereof has a pH of 7.2. In one example, the fraction V or equivalent fraction thereof has a pH of 7.3. In one example, the fraction V or equivalent fraction thereof has a pH of between 6 and 7.5 measured at a temperature of between 8°C to 25°C. In one example, the fraction V or equivalent fraction thereof has a pH of between 6.5 and 7.5 measured at a temperature of between 8°C to 25°C. In one example, the fraction V or equivalent fraction thereof has a pH of between 6.7 and 7.3 measured at a temperature of between 8°C to 25°C. In one example, the fraction V or equivalent fraction thereof has a pH of 6.0 measured at a temperature of between 8°C to 25°C. In one example, the fraction V or equivalent fraction thereof has a pH of 6.1 measured at a temperature of between 8°C to 25°C. In one example, the fraction V or equivalent fraction thereof has a pH of 6.2 measured at a temperature of between 8°C to 25°C. In one example, the fraction V or equivalent fraction thereof has a pH of 6.3 measured at a temperature of between 8°C to 25°C. In one example, the fraction V or equivalent fraction thereof has a pH of 6.4 measured at a temperature of between 8°C to 25°C. In one example, the fraction V or equivalent fraction thereof has a pH of 6.5 measured at a temperature of between 8°C to 25°C. In one example, the fraction V or equivalent fraction thereof has a pH of 6.6 measured at a temperature of between 8°C to 25°C. In one example, the fraction V or equivalent fraction thereof has a pH of 6.7 measured at a temperature of between 8°C to 25°C. In one example, the fraction V or equivalent fraction thereof has a pH of 6.8 measured at a temperature of between 8°C to 25°C. In one example, the fraction V or equivalent fraction thereof has a pH of 6.9 measured at a temperature of between 8°C to 25°C. In one example, the fraction V or equivalent fraction thereof has a pH of 7.0 measured at a temperature of between 8°C to 25°C. In one example, the fraction V or equivalent fraction thereof has a pH of 7.1 measured at a temperature of between 8°C to 25°C. In one example, the fraction V or equivalent fraction thereof has a pH of 7.2 measured at a temperature of between 8°C to 25°C. In one example, the fraction V or equivalent fraction thereof has a pH of 7.3 measured at a temperature of between 8°C to 25°C. In one example, the pH of the fraction V or equivalent fraction thereof is adjusted prior to heating the fraction V or equivalent fraction thereof. In one example, the fraction V or equivalent fraction thereof comprises 50 g/L of albumin, 0.08 mmol per gram of total protein of sodium caprylate, 0.08 mmol per gram of total protein of N-acetyl-DL-tryptophan and has a pH of between 6.7 and 7.3 measured at room temperature. In one example, the fraction V or equivalent fraction thereof comprises 200 g/L of albumin, 0.08 mmol per gram of total protein of sodium caprylate, 0.08 mmol per gram of total protein of N-acetyl-DL-tryptophan and has a pH of between 6.7 and 7.3 measured at room temperature. In one example, the fraction V or equivalent fraction thereof comprises 250 g/L of albumin, 0.08 mmol per gram of total protein of sodium caprylate, 0.08 mmol per gram of total protein of N-acetyl-DL-tryptophan and has a pH of between 6.7 and 7.3 measured at room temperature. In one example, the method further comprises clarification, pasteurisation, terminal incubation and combinations thereof. In one example, the method further comprises clarification of the albumin solution. In one example, the albumin solution is clarified. In one example, the method comprises one or more rounds of clarifying the albumin solution. For example, the method comprises at least one round of clarifying the albumin solution. In one example, the method comprises at least two rounds of clarifying the albumin solution. In one example, the method comprises at least three rounds of clarifying the albumin solution. In one example, the method comprises at least four rounds of clarifying the albumin solution. In one example, the method comprises at least five rounds of clarifying the albumin solution. In one example, the method comprises one or more rounds of heating the fraction V or equivalent fraction thereof and multiple rounds of clarifying the albumin solution. Methods of clarification of the albumin solution will be apparent to the skilled person and/or described herein. For example, the albumin solution is clarified by passing the albumin solution through a filter. For example, a depth or membrane filter can be used. In one example, a polyethersulfone filter is used. For example, the albumin solution is passed through a combination of filters. For example, the combination is a 1.2 and 0.45/0.22 µm membrane filter combination. For example, the albumin solution is clarified by passing the albumin solution through a polyethersulfone filter. For example, the albumin solution is clarified by passing the albumin solution through a depth filter (e.g., BECO® depth filter). In one example, the albumin solution is clarified by passing the albumin solution through a filter press (e.g., BECO® integra plate or compact plate) comprising one or more depth filter(s). In one example, the filter press further comprises one or more filter aid(s) (e.g., cellulose-based filter aids such as Diacel® 150). In one example, the albumin solution is clarified by passing the albumin solution through a lipid-specific filter (e.g., Zeta Plus ™ DEL Series filter). In one example, the albumin solution is clarified Cohn Fraction V (Fr V). In one example, the albumin solution is clarified Kistler/Nitschmann Fraction V (KN V). In one example, the method further comprises pooling of at least two fraction Vs or equivalent fraction thereof such as KN C. For example, the at least two fraction Vs or equivalent fractions thereof are from different Cohn Fr V solutions. In one example, the at least two fraction Vs or equivalent fractions thereof are from different KN C solutions. In one example, the at least two fraction Vs or equivalent fractions thereof are from a Cohn Fr V solution and a KN C solution. In one example, the method further comprises pooling of at least three, or four, or five, or six, or seven, or eight, or nine or ten fraction Vs or equivalent fractions thereof (e.g., KN C). For example, the fraction Vs or equivalent fractions thereof for pooling may be selected from Cohn Fraction V (Fr V), Kistler/Nitschmann Precipitate C (KN C) and combinations thereof. In one example, the method further comprises pasteurisation. In one example, the albumin solution is pasteurised after heating the fraction V or equivalent fraction thereof. For example, pasteurisation comprises the step of heating the albumin solution at a temperature of 60°C for a period of about 10 hours. In one example, pasteurisation is done in a water bath. In one example, the method does not comprise pasteurisation after heating the fraction V or equivalent fraction thereof. In one example, the method further comprises terminal incubation. In one example, the method further comprises terminal incubation of the albumin solution after heating the fraction V or equivalent fraction thereof. In one example, the method further comprises terminal incubation after pasteurising the albumin solution. In one example, the method further comprises terminal incubation as the final step of the method described herein. In one example, terminal incubation comprises heating the albumin solution at a temperature of between 30 to 32°C for a period of at least 14 days. In one example, terminal incubation comprises heating the albumin solution at a temperature of between 20 to 25°C for a period of at least 14 days. In one example, terminal incubation comprises heating the albumin solution at a temperature of between 20 to 25°C for a period of at least 4 weeks. In one example, terminal incubation comprises heating the albumin solution at a temperature of between 20 to 25°C for a period of 14 to 34 days. In one example, terminal incubation comprises heating the albumin solution at a temperature of between 20 to 25°C for a period of 30 to 32 days. In one example, the method of the disclosure is performed as a batch process. In one example, the method of the disclosure is performed as a continuous process. In one example, the method of the disclosure is performed at large scale. For example, the method is performed on an industrial or a commercial scale. Methods of performing on an industrial or a commercial scale will be apparent to a skilled person and/or described herein. For example, the method performed on an industrial scale comprises large scale purification, heat treatment and/or a reduction in proteolytic activity of a fraction V or equivalent fraction thereof comprising albumin. In one example, large scale purification is performed using at least 500 kg of the fraction V or equivalent fraction thereof. For example, large scale purification is performed using between 500 kg to 1,000 kg, or 1,000 kg to 2,500 kg, or 2,500 kg to 5,000 kg, or 5,000 kg to 7,500 kg, or 7,500 kg, or 10,000 kg, or 10,000 kg to 12,500 kg, or 12,500 kg to 15,000 kg of the fraction V or equivalent fraction thereof. In one example, large scale purification is performed using at least 1,000 kg, or 2,500 kg, or 5,000 kg, or 7,500 kg, or 10,000 kg, or 12,500 kg, or 15,000 kg of the fraction V or equivalent fraction thereof. In one example, large scale purification is performed using at least 1,000 kg of the fraction V or equivalent fraction thereof. In one example, large scale purification is performed using at least 2,500 kg of the fraction V or equivalent fraction thereof. In one example, large scale purification is performed using at least 5,000 kg of the fraction V or equivalent fraction thereof. In one example, large scale purification performed using at least 7,500 kg of the fraction V or equivalent fraction thereof. In one example, large scale purification is performed using at least 10,000 kg of the fraction V or equivalent fraction thereof. In one example, large scale purification is performed using at least 12,500 kg of the fraction V or equivalent fraction thereof. In one example, large scale is performed using at least 15,000 kg of the fraction V or equivalent fraction thereof. In one example, the method further comprises formulating the albumin solution (e.g., the heat treated albumin solution and/or the albumin solution with reduced proteolytic activity) into a pharmaceutical composition. The present disclosure provides a pharmaceutical composition comprising an albumin solution purified or produced by a method of the present disclosure. It will be apparent to the skilled person from the disclosure herein that reference to a pharmaceutical composition comprising an albumin solution purified or produced by a method of the present disclosure refers to a composition which meets the appropriate pharmacopoeia standards, such as European Pharmacopoeia (Ph. Eur), United States Pharmacopeia (USP) and Chinese Pharmacopoeia or as otherwise herein defined. For example, a composition suitable for pharmaceutical use is a composition that meets the pharmacopoeia standards, such as Ph. Eur, USP and/or China and which is specifically formulated for administration in humans. For example, following the test procedures as described for a human albumin solution in the Ph. Eur (version 10.6) the human serum albumin preparation is sterile; pyrogen free; has endotoxin levels below 0.5 IU per mL for solutions less than 50 g/L, or less than 1.3 IU per mL for solutions from 50 g/L to 200 g/L, or less than 1.7 IU/mL for solutions greater than 200 g/L; an aluminium content of a maximum of 200 μg/L, a prekallikrein activator (PKA) maximum of 35 IU/mL; a haem content not greater than 0.15; a potassium maximum of 0.05 mmol per gram of protein; a sodium maximum of 160 mmol/L and 95 % to 105% of the content of Na stated on the label; a maximum of 10% polymers and aggregates; not more than 5% of protein has a mobility different from the principal band by zone electrophoresis; a pH of 6.7 to 7.3 and a total protein not less than 9% and not more than 10% of the stated content. In one example, the pharmaceutical composition comprises between 5 to 300 g/L of albumin. For example, the pharmaceutical composition comprises 5 g/L of albumin. In one example, the pharmaceutical composition comprises 10 g/L of albumin. In one example, the pharmaceutical composition comprises 15 g/L of albumin. In one example, the pharmaceutical composition comprises 20 g/L of albumin. In one example, the pharmaceutical composition comprises 25 g/L of albumin. In one example, the pharmaceutical composition comprises 30 g/L of albumin. In one example, the pharmaceutical composition comprises 35 g/L of albumin. In one example, the pharmaceutical composition comprises 40 g/L of albumin. In one example, the pharmaceutical composition comprises 45 g/L of albumin. In one example, the pharmaceutical composition comprises 50 g/L of albumin. In one example, the pharmaceutical composition comprises 55 g/L of albumin. In one example, the pharmaceutical composition comprises 60 g/L of albumin. In one example, the pharmaceutical composition comprises 65 g/L of albumin. In one example, the pharmaceutical composition comprises 70 g/L of albumin. In one example, the pharmaceutical composition comprises 75 g/L of albumin. In one example, the pharmaceutical composition comprises 80 g/L of albumin. In one example, the pharmaceutical composition comprises 85 g/L of albumin. In one example, the pharmaceutical composition comprises 90 g/L of albumin. In one example, the pharmaceutical composition comprises 95 g/L of albumin. In one example, the pharmaceutical composition comprises 100 g/L of albumin. In one example, the pharmaceutical composition comprises 105 g/L of albumin. In one example, the pharmaceutical composition comprises 110 g/L of albumin. In one example, the pharmaceutical composition comprises 115 g/L of albumin. In one example, the pharmaceutical composition comprises 120 g/L of albumin. In one example, the pharmaceutical composition comprises 125 g/L of albumin. In one example, the pharmaceutical composition comprises 130 g/L of albumin. In one example, the pharmaceutical composition comprises 135 g/L of albumin. In one example, the pharmaceutical composition comprises 140 g/L of albumin. In one example, the pharmaceutical composition comprises 145 g/L of albumin. In one example, the pharmaceutical composition comprises 150 g/L of albumin. In one example, the pharmaceutical composition comprises 155 g/L of albumin. In one example, the pharmaceutical composition comprises 160 g/L of albumin. In one example, the pharmaceutical composition comprises 165 g/L of albumin. In one example, the pharmaceutical composition comprises 170 g/L of albumin. In one example, the pharmaceutical composition comprises 175 g/L of albumin. In one example, the pharmaceutical composition comprises 180 g/L of albumin. In one example, the pharmaceutical composition comprises 185 g/L of albumin. In one example, the pharmaceutical composition comprises 190 g/L of albumin. In one example, the pharmaceutical composition comprises 195 g/L of albumin. In one example, the pharmaceutical composition comprises 200 g/L of albumin. In one example, the pharmaceutical composition comprises 205 g/L of albumin. In one example, the pharmaceutical composition comprises 210 g/L of albumin. In one example, the pharmaceutical composition comprises 215 g/L of albumin. In one example, the pharmaceutical composition comprises 220 g/L of albumin. In one example, the pharmaceutical composition comprises 225 g/L of albumin. In one example, the pharmaceutical composition comprises 230 g/L of albumin. In one example, the pharmaceutical composition comprises 235 g/L of albumin. In one example, the pharmaceutical composition comprises 240 g/L of albumin. In one example, the pharmaceutical composition comprises 245 g/L of albumin. In one example, the pharmaceutical composition comprises 250 g/L of albumin. In one example, the pharmaceutical composition comprises 255 g/L of albumin. In one example, the pharmaceutical composition comprises 260 g/L of albumin. In one example, the pharmaceutical composition comprises 265 g/L of albumin. In one example, the pharmaceutical composition comprises 270 g/L of albumin. In one example, the pharmaceutical composition comprises 275 g/L of albumin. In one example, the pharmaceutical composition comprises 280 g/L of albumin. In one example, the pharmaceutical composition comprises 285 g/L of albumin. In one example, the pharmaceutical composition comprises 290 g/L of albumin. In one example, the pharmaceutical composition comprises 295 g/L of albumin. In one example, the pharmaceutical composition comprises 300 g/L of albumin. In one example, the pharmaceutical composition comprises a nominal osmolality of between about 200 mOsm/kg and 500 mOsm/kg. In another example, the pharmaceutical composition comprises a nominal osmolality of between about 100 mOsm/kg and 300 mOsm/kg. In one example, the pharmaceutical composition comprises a nominal osmolality of between 130 to 260 mOsm/kg. In one example, the pharmaceutical composition comprises a nominal osmolality of between 250 and 270 mOsm/kg. In one example, the pharmaceutical composition comprises a nominal osmolality of 258 mOsm/kg. In one example, the pharmaceutical composition comprises a nominal osmolality of 260 mOsm/kg. For example, the pharmaceutical composition comprises a nominal osmolality of between about 120 mOsm/kg and 140 mOsm/kg. In one example, the pharmaceutical composition comprises a nominal osmolality of 130 mOsm/kg. For example, the pharmaceutical composition comprises a nominal osmolality of 130 mOsm/kg, or 140 mOsm/kg, or 150 mOsm/kg, or 160 mOsm/kg, or 170 mOsm/kg, or 180 mOsm/kg, or 190 mOsm/kg, or 200 mOsm/kg, or 210 mOsm/kg, or 220 mOsm/kg, or 230 mOsm/kg, or 240 mOsm/kg, or 250 mOsm/kg, or 251 mOsm/kg, or 252 mOsm/kg, or 253 mOsm/kg, or 254 mOsm/kg, or 255 mOsm/kg, or 256 mOsm/kg, or 257 mOsm/kg, or 258 mOsm/kg, or 259 mOsm/kg, or 260 mOsm/kg. In one example, the pharmaceutical composition comprises a pH of between 6.7 and 7.3. In one example, the pharmaceutical composition comprises a pH of 6.7. In one example, the pharmaceutical composition comprises a pH of 6.8. In one example, the pharmaceutical composition comprises a pH of 6.9. In one example, the pharmaceutical composition comprises a pH of 7.0. In one example, the pharmaceutical composition comprises a pH of 7.1. In one example, the pharmaceutical composition comprises a pH of 7.2. In one example, the pharmaceutical composition comprises a pH of 7.3. In one example, the pharmaceutical composition comprises a Prekallikrein activator (PKA) level of less than 35 IU/mL. In one example, the pharmaceutical composition comprises a PKA level of less than 30 IU/mL. In one example, the pharmaceutical composition comprises a PKA level of less than 25 IU/mL. In one example, the pharmaceutical composition comprises a PKA level of less than 20 IU/mL. In one example, the pharmaceutical composition comprises a PKA level of less than 15 IU/mL. In one example, the pharmaceutical composition comprises a PKA level of less than 10 IU/mL. In one example, the pharmaceutical composition comprises a PKA level of less than 5 IU/mL. In one example, the pharmaceutical composition comprises a PKA level of less than 3 IU/mL. In one example, the pharmaceutical composition comprises an aluminium content of less than 200 mcg/L. In one example, the pharmaceutical composition comprises an aluminium content of less than 150 mcg/L. In one example, the pharmaceutical composition comprises an aluminium content of less than 100 mcg/L. In one example, the pharmaceutical composition comprises an aluminium content of less than 50 mcg/L. In one example, the pharmaceutical composition comprises an aluminium content of less than 20 mcg/L. In one example, the pharmaceutical composition comprises a potassium content of less than 0.002 M. In one example, the pharmaceutical composition comprises a potassium content of less than 0.001 M. In one example, the pharmaceutical composition further comprises one or more stabilisers. In one example, the one or more stabilisers is selected from the group consisting of an amino acid, a polyol, a surfactant, sodium N-acetyl-tryptophan, sodium caprylate and combinations thereof. In one example, the one or more stabilisers is an amino acid stabiliser. For example, the amino acid stabiliser is selected from the group consisting of glycine, proline and combinations thereof. In one example, the amino acid stabiliser is L-proline. In one example, the pharmaceutical composition further comprises 200 mmol/L to 300 mmol/L of L-proline. For example, the pharmaceutical composition further comprises 225 mmol/L to 275 mmol/L of L- proline. In one example, the pharmaceutical composition further comprises 240 mmol/L to 260 mmol/L of L-proline. For example, the pharmaceutical composition further comprises 250 mmol/L of L-proline. In one example, the amino acid stabiliser is glycine. In one example, the one or more stabilisers is a polyol. For example, the polyol is selected from the group consisting of sorbitol, maltose and combinations thereof. In one example, the stabiliser is sorbitol. In one example, the stabiliser is maltose. In one example, the one or more stabilisers is a surfactant. For example, the surfactant is polysorbate. For example, the polysorbate is polysorbate 80. In one example, the stabiliser is sodium acetyltryptophanate. In one example, the stabiliser is octanoate. In one example, the stabiliser is sodium acetyltryptophanate and sodium octanoate. In one example, the pharmaceutical composition further comprises a tonicity agent. For example, the tonicity agent is sodium chloride. In one example, the pharmaceutical composition further comprises a solvent. For example, the solvent is water for injections. In one example, the pharmaceutical composition comprises albumin and one or more of the following excipients: a stabiliser, a polyol and a surfactant. In one example, the pharmaceutical composition comprises a sodium content of less than 140 mmol/L. In one example, the pharmaceutical composition comprises 250 g/L of albumin, the nominal osmolality of 258 mOsm/kg, 20 mmol of sodium acetyltryptophanate, 20 mmol of sodium octanoate and a sodium content of 140 mmol/L. In one example, the pharmaceutical composition comprises 200 g/L of albumin, the nominal osmolality of 258 mOsm/kg, 16 mmol of sodium acetyltryptophanate, 16 mmol of sodium octanoate and a sodium content of 140 mmol/L. In one example, the pharmaceutical composition comprises 50 g/L of albumin, the nominal osmolality of 258 mOsm/kg, 4 mmol of sodium acetyltryptophanate, 4 mmol of sodium octanoate and a sodium content of 140 mmol/L. In one example, the pharmaceutical composition comprises 200 g/L of albumin, the nominal osmolality of 130 mOsm/kg, 32 mmol/L of octanoate and a sodium content of 48 to 100 mmol/L. In one example, the pharmaceutical composition comprises 40 g/L of albumin, the nominal osmolality of 260 mOsm/kg, 6.4 mmol/L of octanoate, 128 mmol/L of chloride and a sodium content of 140 mmol/L. In one example, the pharmaceutical composition does not comprise preservatives. For example, the pharmaceutical composition is preservative free. The present disclosure also provides the pharmaceutical composition described herein for use in treating, preventing and/or delaying progression of a condition in a subject. For example, the present disclosure provides a pharmaceutical composition described herein for use in treating a condition in a subject. In another example, the present disclosure provides a pharmaceutical composition described herein for use in preventing a condition in a subject. In a further example, the present disclosure provides a pharmaceutical composition described herein for use in delaying progression of a condition in a subject. In some examples, the pharmaceutical composition is present in a vial, a prefilled syringe or an autoinjector device. The present disclosure also provides a prefilled syringe comprising the pharmaceutical composition described herein. The present disclosure also provides an autoinjector device comprising the pharmaceutical composition described herein. In one example, the composition of the disclosure is administered subcutaneously to the subject in need thereof. In another example, the composition of the disclosure is administered intravenously to the subject in need thereof. In one example, the composition of the disclosure is self-administered. For example, the composition of the disclosure is self-administered subcutaneously. In one example, the composition of the disclosure is provided in a pre-filled syringe. In one example, the composition of the disclosure is self-administered subcutaneously, with a pre-filled syringe. The present disclosure further provides use of an albumin solution purified or produced by a method described herein in the manufacture of a medicament for treating, preventing and/or delaying progression of a condition in a subject. For example, the present disclosure provides use of the albumin solution purified or produced by a method described herein in the manufacture of a medicament for treating a condition in a subject. In another example, the present disclosure provides use of the albumin solution purified or produced by a method described herein in the manufacture of a medicament for preventing a condition in a subject. In a further example, the present disclosure provides use of the albumin solution purified or produced by a method described herein in the manufacture of a medicament for delaying progression of a condition in a subject. The present disclosure also provides a method of treating, preventing and/or delaying progression of a condition in a subject, the method comprising administering the pharmaceutical composition of the present disclosure to the subject. For example, the present disclosure provides a method of treating a condition in a subject. In another example, the present disclosure provides a method of preventing a condition in a subject. In a further example, the present disclosure provides a method of delaying progression of a condition in a subject. The present disclosure also provides a kit for use in treating or preventing or delaying progression of a condition in a subject, the kit comprising: (a) at least one pharmaceutical composition described herein; (b) instructions for using the kit in treating or preventing or delaying the condition in the subject; and (c) optionally, at least one further therapeutically active compound or drug. In one example, the condition is selected from a group consisting of hypoproteinaemia, shock, burns, adult respiratory distress syndrome, haemodialysis, plasma exchange, cardiopulmonary bypass, acute liver failure, hypoalbuminemia, hypovolemia and combinations thereof. In one example of any method described herein, the subject is a mammal, for example a primate such as a human. BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 is representation of albumin bulk samples heated under various conditions. (A) and (B) heated between 72°C to 76.5°C for up to 5 minutes and (C) heated at 73°C (left) and 72.5°C (right) for 5 minutes. Figure 2 is a graphical representation of the proteolytic activity of (A) S-2288 and (B) S-2302 at various temperatures. Figure 3 is a graphical representation of the proteolytic activity of S-2288 and S-2302 at 60°C. Figure 4 is a graphical representation of (A) Actual by Predicted Plot for monomer content; (B) Residual by Predicted Plot for monomer content; and (C) Studentized Residuals of monomer content. Samples of batch P100470852 are denoted as squares and samples of batch P100470856 are denoted as dots. The light grey colour represents heating at +70°C, medium grey relates to a temperature of +71°C, dark grey to +72°C, and the black symbols are related to heating at +73°C. Figure 5 is a graphical representation of the Prediction Profiler for monomer content. Figure 6 is a graphical representation of the Prediction Profiler for Proteolytic Activity of (A) S-2288, (B) S-2302 and (C) Contour Profiler for Proteolytic Activity of S-2302. Figure 7 is a graphical representation of the Prediction Profiler for peak area. Figure 8 is a graphical representation of non-reduced (A and C) and reduced (B and D) SDS-PAGE Gels. The samples applied to the gel are shown in Table 9. Figure 9 is a graphical representation of turbidity behaviour of (A) batch P100470852 and (B) batch P100470856. Figure 10 is a graphical representation of (A) the Prediction Profiler for all dependent variables, (B) Contour Profiler with Batch P100470852 and (C) Contour Profiler with Batch P100470856. Figure 11 is a graphical representation of a SEC Chromatogram of (A) batch P100470852 and (B) batch P100470856; the polymer peak of (C) batch P100470852: the unheated sample (sample before heat treatment), sample heated at +60°C for 10 hours, and the three samples (sample no. 3, 4 and 5) as shown in Table 10 and (D) batch P100470856: the unheated sample (sample before heat treatment), sample heated at +60°C for 10 hours, and the three samples (sample no.18, 19 and 20) as shown in Table 10. Figure 12 is a schematic flow diagram illustrating an exemplary method for the preparation of a fraction V or equivalent fraction thereof obtained from an ethanol fractionation process (e.g., Cohn purification or Kistler/Nitschmann purification or a variation thereof). DETAILED DESCRIPTION General Throughout this specification, unless specifically stated otherwise or the context requires otherwise, reference to a single step, composition of matter, group of steps or group of compositions of matter shall be taken to encompass one and a plurality (i.e. one or more) of those steps, compositions of matter, groups of steps or groups of compositions of matter. Those skilled in the art will appreciate that the present disclosure is susceptible to variations and modifications other than those specifically described. It is to be understood that the disclosure includes all such variations and modifications. The disclosure also includes all of the steps, features, compositions and compounds referred to or indicated in this specification, individually or collectively, and any and all combinations or any two or more of said steps or features. The present disclosure is not to be limited in scope by the specific examples described herein, which are intended for the purpose of exemplification only. Functionally equivalent products, compositions and methods are clearly within the scope of the present disclosure. Any example of the present disclosure herein shall be taken to apply mutatis mutandis to any other example of the disclosure unless specifically stated otherwise. Unless specifically defined otherwise, all technical and scientific terms used herein shall be taken to have the same meaning as commonly understood by one of ordinary skill in the art (for example, in cell culture, molecular genetics, immunology, immunohistochemistry, protein chemistry, and biochemistry). The term “and/or”, e.g., “X and/or Y” shall be understood to mean either “X and Y” or “X or Y” and shall be taken to provide explicit support for both meanings or for either meaning. The term “about” in relation to a numerical value x is optional and means, for example, any number within 1%, 5% or 10% of the referenced number. In one example, the term “about” in reference to temperature shall be understood to refer to ± 0.2°C. The term “about” also encompasses the exact number recited. Throughout this specification the word “comprise”, or variations such as “comprises” or “comprising”, will be understood to imply the inclusion of a stated element, integer or step, or group of elements, integers or steps, but not the exclusion of any other element, integer or step, or group of elements, integers or steps. As used herein the term “derived from” shall be taken to indicate that a specified integer may be obtained from a particular source albeit not necessarily directly from that source. Furthermore, as used herein the singular forms of “a”, “and” and “the” include plural references unless the context clearly dictates otherwise. Selected Definitions Serum albumin, or blood albumin, is the most abundant blood protein and functions as a carrier protein for steroids, fatty acids and thyroid hormones in the blood, as well as playing a major role in stabilising extracellular fluid volume. As used herein, the term “albumin solution” shall be understood to refer to a heat treated solution comprising albumin and/or an albumin solution with reduced proteolytic activity. The term “purify”, or “purifying” or “purification” shall be taken to mean the isolation, whether completely or partially, of albumin from a fraction V or equivalent fraction thereof. The terms “reduce” or “reducing” are used herein to refer to lowering the amount or level of any of the features listed herein (e.g., proteolytic activity), relative to either the amount or level in the fraction V or equivalent fraction thereof prior to heating at a temperature. The term “proteolytic activity” shall be understood to mean any activity relating to proteolytic enzymes. The term “heat treatment” or “heat treated” shall be understood to mean a method of heating a mixture of solution, holding it at that temperature, and then cooling it back to the original temperature (e.g., room temperature). The term “cryo-precipitate” or “cryo-precipitates” refers to proteins in plasma that precipitate out of solution when a unit of fresh frozen plasma is slowly thawed in the cold. Cryo-precipitates include factor VIII, fibrinogen, von Willebrand factor, factor XIII and platelet membrane microparticles. The term “cryo-poor plasma” shall be taken to mean plasma removed of cryo- precipitates. The term “cryo-rich plasma” shall be taken to mean plasma comprising components typically found in plasma. The term “partially purified plasma solution” shall be understood to mean any fraction or solution from any stage of plasma purification. The term “partially purified cryo-poor plasma” shall be understood to encompass plasma solutions such as IgG-poor cryo-poor plasma, cryo-poor plasma after plasma thromboplastin component adsorption, cryo-poor plasma after prothrombin complex factors adsorption, and after cryo-poor plasma after diethylaminoethyl (DEAE) and quaternary aminoethyl (QAE) adsorption. The term “fraction V or equivalent fraction thereof” shall be understood to refer to a mixture of albumin (e.g., of human or animal origin or other original sources or fractions thereof) and one or more additional proteins (e.g., an acid glycoprotein, a Zn-α2-glycoprotein, α2HS-glycoprotein, polysaccharides, amino acids and lipids) that has been obtained from an ethanol fractionation process (e.g., Cohn purification or Kistler/Nitschmann purification or a variation thereof) and has been resuspended in a solution. The term “Cohn Fraction V” or “Fr V” shall be understood to refer to the fifth fraction of plasma proteins derived from the Cohn purification fractionation process or variation thereof. The term “Kistler/Nitschmann Precipitate C” or “KN C” or “Precipitate C” shall be understood to refer to the fifth fraction of plasma proteins derived from the Kistler/Nitschmann purification fractionation process or variation thereof. In one example, a Kistler/Nitschmann Precipitate C is an equivalent fraction to a Cohn Fraction V. The term “purity” shall refer to the portion of the albumin relative to the total protein content expressed as a percentage. The term “impurity” or “impurities” shall be taken to include one or more components in the fraction V or equivalent fraction thereof other than albumin. For example, impurities can include prekallikrein activator (PKA), plasma lipids, plasma proteins, proteases (e.g. serine proteases, kallikrein, plasmin and FXa), serine protease inhibitors (e.g. C1 inhibitor, alpha-1- antitrypsin and anti-thrombin), IgG, IgA, IgM, factor VIII, fibrinogen, von Willebrand factor, activated clotting factors (e.g. FXa, FIXa, FVIIa and thrombin), factor XIII, contact system factors (e.g. FXIa, FXIIa and plasma kallikrein), factor IX, prothrombin complex, C1 esterase inhibitor, protein C, anti-thrombin III, a RhD immunoglobulin and platelet membrane microparticles. In one example, the impurity is selected from the group consisting of prekallikrein activator (PKA), plasma lipids, plasma proteins, proteases (e.g. serine proteases, kallikrein, plasmin and FXa), serine protease inhibitors (e.g. C1 inhibitor, alpha-1- antitrypsin and anti-thrombin), IgG, IgA, IgM, factor VIII, fibrinogen, von Willebrand factor, activated clotting factors (e.g. FXa, FIXa, FVIIa and thrombin), factor XIII, contact system factors (e.g. FXIa, FXIIa and plasma kallikrein), factor IX, prothrombin complex, C1 esterase inhibitor, protein C, anti-thrombin III, a RhD immunoglobulin, platelet membrane microparticles and combinations thereof. The term “monomer” shall be understood to mean the portion of the albumin present as a monomer relative to the total protein content expressed as a percentage. The term “aggregate” shall be understood to mean the portion of the albumin present as an oligomer, polymer or aggregate relative to the total protein content expressed as a percentage. The term “detectable amount” shall be understood to mean any identifiable quantity or amount of, for example, ethanol present in a solution. The term “industrial or commercial scale” or “large scale” or “manufacturing scale” shall refer to the amount of product that would be produced in a batch that was designed for clinical testing, formulation, sale and/or distribution to the public. For example, industrial scale refers to large scale purification of albumin to produce the albumin product. The term “pharmaceutical composition” shall be taken to mean a formulation of albumin with compounds generally accepted in the art for the delivery of albumin to a subject. Exemplary compounds include all pharmaceutically acceptable carriers, diluents or excipients thereof. The term “treat” or “treatment” or “treating” shall be taken to mean administering a therapeutically effective amount of albumin such that one or more symptoms or characteristics of the condition is reduced in the subject or that the subject is no longer clinically diagnosed with the condition. The term “preventing”, “prevent” or “prevention” includes providing prophylaxis with respect to occurrence or recurrence of a specified condition in a subject. A subject may be predisposed to or at risk of developing a condition but has not yet been diagnosed with the condition. As used herein, the phrase “delaying progression of” includes reducing or slowing down the progression of a condition in a subject and/or at least one symptom of the condition. The term “condition” shall be taken to mean a state of being or health status of a subject in need of treatment with serum albumin. Exemplary conditions include but are not limited to hypoproteinaemia, shock, burns, adult respiratory distress syndrome, haemodialysis, plasma exchange cardiopulmonary bypass, acute liver failure, hypoalbuminemia and hypovolemia. The term “subject” shall be taken to mean any animal including humans, for example a mammal. Exemplary subjects include but are not limited to humans and non-human primates. For example, the subject is a human. Albumin Solution The present disclosure also provides a method of heat treating a fraction V or equivalent fraction thereof comprising albumin, the method comprising heating the fraction V or equivalent fraction thereof at a certain temperature for a certain period of time, thereby producing a heat treated albumin solution. The present disclosure also provides a method of heat treating a fraction V or equivalent fraction thereof comprising albumin, the method comprising one or more rounds of heating the fraction V or equivalent fraction thereof at a certain temperature for a certain period of time, thereby producing a heat treated albumin solution. The present disclosure also provides a method of heat treating a fraction V or equivalent fraction thereof comprising albumin, the method comprising one or more rounds of heating the fraction V or equivalent fraction thereof at a certain temperature for a certain period of time, one or more rounds of clarifying the fraction V or equivalent fraction thereof after heating the fraction V or equivalent fraction thereof, thereby producing a heat treated albumin solution. The present disclosure further provides a method of reducing proteolytic activity of a fraction V or equivalent fraction thereof comprising albumin, the method comprising heating the fraction V or equivalent fraction thereof at a certain temperature for a certain period of time, thereby producing an albumin solution with reduced proteolytic activity. The present disclosure further provides a method of reducing proteolytic activity of a fraction V or equivalent fraction thereof comprising albumin, the method comprising one or more rounds of heating the fraction V or equivalent fraction thereof at a certain temperature for a certain period of time, thereby producing an albumin solution with reduced proteolytic activity. The present disclosure further provides a method of reducing proteolytic activity of a fraction V or equivalent fraction thereof comprising albumin, the method comprising heating the fraction V or equivalent fraction thereof at a certain temperature for a certain period of time, one or more rounds of clarifying the fraction V or equivalent fraction thereof after heating the fraction V or equivalent fraction thereof, thereby producing an albumin solution with reduced proteolytic activity. It will be apparent to the skilled person suitable methods for heating the fraction V or equivalent fraction thereof to the appropriate temperature for the required period. Analysis of albumin solution Methods of determining total protein content, purity, percentage of albumin monomer and albumin aggregate, turbidity and proteolytic activity will be apparent to the skilled person and/or described herein. Total protein content In one example, the total protein content of the albumin solution is assessed. In one example, the total protein content of the fraction V or equivalent fraction thereof is assessed. Suitable methods for assessing the total protein content will be apparent to the skilled person and/or are described herein. In one example, the total protein content is determined using nephelometry (e.g., on a BN II system with a commercially available test procedure and test reagents from Siemens Healthcare GmbH). In one example, the total protein content is determined using an optical density measurement at 280 nm. In one example, the total protein content accounting for turbidity is determined using an optical density measurement at 280 nm less an optical density measurement at 320 nm. In one example, the total protein content is determined using UV absorbance. In other examples, the total protein content is determined using an analytical assay (e.g., Kjeldahl method, Dumas method, Bradford assays, Lowry assay and bicinchoninic acid assay). Purity In one example, the purity of the albumin solution is assessed. In one example, the purity of the fraction V or equivalent fraction thereof is assessed. Suitable methods for assessing the purity will be apparent to the skilled person and/or are described herein. In one example, purity is determined by SDS-PAGE and MALDI-TOF-MS peptide fingerprint analysis. Briefly, the albumin solution described herein is loaded onto a suitable SDS-PAGE gel (e.g., 8-16% TRIS-glycine), along with a protein size marker and a positive control for the albumin (e.g., Alburex or Albumex) under reduced and non-reduced conditions. Proteins are separated based on size and protein bands of interest are isolated, processed and analysed by MALDI-TOF-MS. In another example, purity is determined by SDS-PAGE and LC-ESI-MS/MS. In another example, purity is determined by RP-HPLC and CE-SDS. In another example, purity is determined by agarose gel electrophoresis. In one example, purity is determined by acetate cellulose electrophoresis and SDS- PAGE. In one example, purity is determined by nephelometry. Briefly, the albumin solution is analysed by nephelometry for the target protein albumin and impurities such as α1-acid glycoprotein (AAG); ceruloplasmin (CER), haptoglobin (HPT); hemopexin (HPX); prealbumin (PRE) and transferrin (TRF). Yield and impurity reduction are calculated from the nephelometric data. In some examples, the nephelometry is immunonephelometry. Turbidity In one example, the turbidity of the albumin solution is assessed. Suitable methods for assessing the turbidity of the albumin solution will be apparent to the skilled person and/or are described herein. For example, turbidity is determined using an optical absorbance detector (e.g., Photometer Evolution 220, Thermo Scientific). In one example, wavelength is measured at 320 nm. In another example, turbidity is determined using nephelometry. In another example, turbidity is determined using optoymetry. In another example, turbidity is determined using turbidimetry (e.g., using a Hach TL2360 hand-held turbidimeter meter). Structural integrity and post-translational modifications The structural integrity and/or the post-translational modifications of the albumin solution can be determined by assessing the particle size of the components present in the albumin solution. For example, the particle size is determined using chromatography methods, mass spectrometry methods, capillary zone electrophoresis and/or spectroscopic techniques (e.g., Naldi M, Baldassarre M, Domenicali M, Bartolini M, Caraceni P. Structural and functional integrity of human serum albumin: Analytical approaches and clinical relevance in patients with liver cirrhosis. J Pharm Biomed Anal. 2017 Sep 10;144:138-153. doi: 10.1016/j.jpba.2017.04.023. Epub 2017 Apr 18. PMID: 28465079.). Further methods for assessing particle size will be apparent to a skilled person and/or described herein. In one example, the percentage of albumin monomer is determined by HPLC. In another example, the percentage of albumin aggregate is determined by HPLC. For example, the HPLC is size-exclusion chromatography (SE-HPLC). In some examples, the SE-HPLC is completed at a pressure of about 10 to about 100 bar. In one example, the percentage of albumin monomer is determined by SDS-PAGE. In another example, the percentage of albumin aggregate is determined by SDS-PAGE. Proteolytic activity The proteolytic activity of the albumin solution can be assessed by measuring the activity of thrombin, general serine proteases, FXIa, kallikrein, plasmin and FXa e.g., using commercially available kits, such as thrombin activity assay kit (S-2238), general serine protease assay kit (S-2288), kallikrein activity assay kit (S-2302), plasmin activity assay kit (S- 2251) and FXa activity kit (S-2765). Methods for assessing proteolytic activity will be apparent to a skilled person and/or described herein. Prekallikrein Activator (PKA) is a biologically active fragment released from activated Factor XII, and has been associated with clinical hypotensive reactions with albumin. PKA activates the zymogen prekallikrein (PK) to kallikrein, which in turn causes rapid activation of the kinin pathway due to a positive feedback mechanism, leading to vasodilation and hypotension. Strict pharmacopoeial limits now apply to control PKA in albumin, the Ph. Eur (2008) limit for albumin is 35 IU/mL for both 4.5/5% and 20/25% presentations. Kallikrein catalyses the hydrolysis of paranitroaniline (PNA). Thus, the presence of PKA can be measured indirectly by measuring hydrolysis of PNA from the chromogenic substrate S-2302 substrate and the PNA is measured at 405 nm. Serine proteases (e.g., plasmin, trypsin and thrombin) are biologically active fragments and catalyse the hydrolysis of PNA. The presence of serine proteases can be determined by measuring hydrolysis of PNA from the chromogenic substrate S-2288 substrate and the PNA is measured at 405 nm. Additional purification steps Additional purification steps can be performed after heating the albumin solution. In one example, the method further comprises pasteurisation and/or terminal incubation of the albumin solution. Additional purification steps will be apparent to the skilled person and/or described herein. In one example, the method further comprises pasteurisation of the albumin solution. The Ph. Eur and USP require that albumin is pasteurised after it is filled into the final container. This simple measure ensures that there is no risk of recontamination of the product once it has been filled and pasteurised. In one example, the method further comprises terminal incubation of the albumin solution. The requirement to incubate the pasteurised final product (e.g., an albumin solution) is also set out in the pharmacopoeia: Ph. Eur states not less than 14 days at 30-32°C, or not- less-than 4 weeks at 20-25°C; USP states at least 14 days at 20-35°C. In conjunction with visual inspection, terminal incubation is designed to provide additional assurance of the sterility of the product through the detection of microbial growth during inspection. Pharmaceutical Compositions The present disclosure provides a pharmaceutical composition comprising an albumin solution (e.g., the purified albumin solution, the heat treated albumin solution and/or the albumin solution with reduced proteolytic activity) produced by a method of the disclosure. Albumin solutions (e.g., a heat treated albumin solution and/or an albumin solution with reduced proteolytic activity) of the disclosure (syn. active ingredients) are useful for formulation into a pharmaceutical composition for parenteral, such as intravenous administration or subcutaneous administration, for therapeutic and prophylactic treatment. For example, the serum albumin conjugate is administered intravenously. The pharmaceutical compositions for administration will commonly comprise a solution of the albumin solution of the disclosure dissolved in a pharmaceutically acceptable carrier, such as an aqueous carrier. A variety of aqueous carriers can be used, e.g., buffered saline and the like. The pharmaceutical compositions can contain pharmaceutically acceptable carriers as required to approximate physiological conditions such as pH adjusting and buffering agents, toxicity adjusting agents and the like, for example, sodium acetate, sodium chloride, potassium chloride, calcium chloride, sodium lactate and the like. The concentration of the albumin solution of the present disclosure in these formulations can vary widely, and will be selected primarily based on fluid volumes, viscosities, body weight and the like in accordance with the particular mode of administration selected and the patient's needs. The vehicles can contain minor amounts of additives that enhance isotonicity and chemical stability, e.g., buffers and preservatives. Suitable pharmaceutical compositions in accordance with the disclosure will generally include an amount of the albumin solution admixed with an acceptable pharmaceutical carrier, such as a sterile aqueous solution, to give a range of final concentrations, depending on the intended use. The techniques of preparation are generally known in the art as exemplified by Remington's Pharmaceutical Sciences, 16th Ed. Mack Publishing Company, 1980. In one example, the pharmaceutical composition comprises an albumin solution (e.g., the purified albumin solution, the heat treated albumin solution and/or the albumin solution with reduced proteolytic activity) produced by a method of the present disclosure. In one example, the pharmaceutical composition comprises 40 g/L to 300 g/L of albumin. For example, the pharmaceutical composition comprises, 40 g/L, 45 g/L, 50 g/L, 55 g/L, 60 g/L, 65 g/L, 70 g/L, 75 g/L, 80 g/L, 85 g/L, 90 g/L, 95 g/L, 100 g/L, 105 g/L, 110 g/L, 115 g/L, 120 g/L, 125 g/L, 130 g/L, 135 g/L, 140 g/L, 145 g/L, 150 g/L, 155 g/L, 160 g/L, 165 g/L, 170 g/L, 175 g/L, 180 g/L, 185 g/L, 190 g/L, 195 g/L, 200 g/L, 205 g/L, 210 g/L, 215 g/L, 220 g/L, 225 g/L, 230 g/L, 235 g/L, 240 g/L, 245 g/L, 250 g/L, 255 g/L, 260 g/L, 265 g/L, 270 g/L, 275 g/L, 280 g/L, 285 g/L, 290 g/L, 295 g/L, or 300 g/L of albumin. Formulations of the albumin solution to be administered will vary according to the route of administration and formulation (e.g., solution, emulsion, capsule) selected. The albumin solution can be stored in the liquid stage or can be lyophilised for storage and reconstituted in a suitable carrier prior to use according to art-known lyophilization and reconstitution techniques. Method of use As discussed herein, the present disclosure provides a method of treating, preventing and/or delaying progression of a condition in a subject, comprising administering the pharmaceutical composition described herein to the subject. In one example, the condition is hypoproteinaemia. In one example, the condition is shock. In one example, the condition is a burn. In one example, the condition is adult respiratory distress syndrome. In one example, the condition is haemodialysis. In one example, the condition is plasma exchange. In one example, the condition is cardiopulmonary bypass. In one example, the condition is acute liver failure. In one example, the condition is hypoalbuminemia. In one example, the condition is hypovolemia. In one example, the condition is a bleeding disorder. In one example, the subject suffers from a bleeding disorder. The bleeding disorder can be inherited or acquired. For example, a subject suffering from a bleeding disorder has suffered a symptom of a bleeding disorder, such as easy bruising, bleeding gums, heavy bleeding from small cuts or dental work, unexplained nosebleeds, heavy menstrual bleeding, bleeding into joints, excessive bleeding following surgery or combinations thereof. In one example, the subject is at risk of developing a bleeding disorder. A subject is at risk if he or she has a higher risk of developing a bleeding disorder than a control population. The control population can include one or more subjects selected at random from the general population (e.g., matched by age, gender, race and/or ethnicity) who have not suffered from or have a family history of angina, stroke and/or heart attack. A subject can be considered at risk for a bleeding disorder if a “risk factor” associated with a bleeding disorder is found to be associated with that subject. A risk factor can include any activity, trait, event or property associated with a given disorder, for example, through statistical or epidemiological studies on a population of subjects. A subject can thus be classified as being at risk for a bleeding disorder even if studies identifying the underlying risk factors did not include the subject specifically. For example, a subject who has excessive bleeding is at risk of developing a bleeding disorder because the frequency of a bleeding disorder is increased in a population of subjects who have excessive bleeding as compared to a population of subjects who do not. In one example, the subject is at risk of developing a bleeding disorder and the pharmaceutical composition is administered before or after the onset of symptoms of a bleeding disorder. In one example, the pharmaceutical composition is administered before the onset of symptoms of a bleeding disorder. In one example, the pharmaceutical composition is administered after the onset of symptoms of a bleeding disorder. In one example, the pharmaceutical composition is administered at a dose that alleviates or reduces one or more of the symptoms of a bleeding disorder in a subject at risk. The methods of the present disclosure can be readily applied to any form of bleeding disorder in a subject. A method of the present disclosure can also include co-administration of the pharmaceutical composition according to the disclosure together with the administration of another therapeutically effective agent for the prevention or treatment of a bleeding disorder. As will be apparent from the foregoing, the present disclosure provides methods of concomitant therapeutic treatment of a subject, comprising administering to a subject in need thereof an effective amount of a first agent and a second agent, wherein the first agent is a pharmaceutical composition of the present disclosure, and the second agent is also for the prevention or treatment of a bleeding disorder. As used herein, the term “concomitant” as in the phrase "concomitant therapeutic treatment" includes administering a first agent in the presence of a second agent. A concomitant therapeutic treatment method includes methods in which the first, second, third or additional agents are co-administered. A concomitant therapeutic treatment method also includes methods in which the first or additional agents are administered in the presence of a second or additional agent, wherein the second or additional agent, for example, may have been previously administered. A concomitant therapeutic treatment may be executed step-wise by different actors. For example, one actor may administer to a subject a first agent and as a second actor may administer to the subject a second agent and the administering steps may be executed at the same time, or nearly the same time, or at distant times, so long as the first agent (and/or additional agents) are after administration in the presence of the second agent (and/or additional agents). The actor and the subject may be the same entity (e.g., a human). The optimum concentration of the active ingredient(s) in the chosen medium can be determined empirically, according to procedures known to the skilled artisan, and will depend on the ultimate pharmaceutical formulation desired. The dosage ranges for the administration of the pharmaceutical composition of the disclosure are those large enough to produce the desired effect. For example, the pharmaceutical composition comprises an effective amount of an albumin solution (e.g., the purified albumin solution, the heat treated albumin solution and/or the albumin solution with reduced proteolytic activity). In one example, the pharmaceutical composition comprises a therapeutically effective amount of the albumin solution. In another example, the composition comprises a prophylactically effective amount of the albumin solution. The dosage should not be so large as to cause adverse side effects, such as paradoxical bleedings and development of inhibitors. Generally, the dosage will vary with the age, condition, sex and extent of the disease in the patient and can be determined by one of skill in the art. The dosage can be adjusted by the individual physician in the event of any complication. Dosage can vary from about 0.1 mg/kg to about 300 mg/kg, e.g., from about 0.2 mg/kg to about 200 mg/kg, such as, from about 0.5 mg/kg to about 20 mg/kg, in one or more dose administrations daily, for one or several days. In some examples, the pharmaceutical composition is administered at an initial (or loading) dose which is higher than subsequent (maintenance doses). In some examples, a dose escalation regime is used, in which the pharmaceutical composition is initially administered at a lower dose than used in subsequent doses. This dosage regime is useful in the case of subject’s initially suffering adverse events. In the case of a subject that is not adequately responding to treatment, multiple doses in a week may be administered. Alternatively, or in addition, increasing doses may be administered. A subject may be retreated with the pharmaceutical composition, by being given more than one exposure or set of doses, such as at least about two exposures of the pharmaceutical composition, for example, from about 2 to 60 exposures, and more particularly about 2 to 40 exposures, most particularly, about 2 to 20 exposures. In one example, any retreatment may be given when signs or symptoms of disease return, e.g., a bleeding episode. In another example, any retreatment may be given at defined intervals. For example, subsequent exposures may be administered at various intervals, such as, for example, about 24- 28 weeks or 48-56 weeks or longer. For example, such exposures are administered at intervals each of about 24-26 weeks or about 38-42 weeks, or about 50-54 weeks. In the case of a subject that is not adequately responding to treatment, multiple doses in a week may be administered. Alternatively, or in addition, increasing doses may be administered. In another example, for subjects experiencing an adverse reaction, the initial (or loading) dose may be split over numerous days in one week or over numerous consecutive days. Administration of the pharmaceutical composition according to the methods of the present disclosure can be continuous or intermittent, depending, for example, on the recipient's physiological condition, whether the purpose of the administration is therapeutic or prophylactic, and other factors known to skilled practitioners. The administration may be essentially continuous over a preselected period of time or may be in a series of spaced doses, e.g., either during or after development of a condition. Kits and Other Compositions of Matter Another example of the disclosure provides kits containing a albumin solution (e.g., a heat treated albumin solution and/or an albumin solution with reduced proteolytic activity) of the present disclosure useful for the treating, preventing and/or delaying progression of a condition as described herein. In one example, the kit comprises (a) a container comprising an albumin solution optionally in a pharmaceutically acceptable carrier or diluent; and (b) a package insert with instructions for treating or preventing a condition in a subject. In one example, the kit comprises (a) a container comprising an albumin solution; (b) instructions for using the kit in treating, preventing and/or delaying progression of the condition in the subject; and (c) optionally, at least one further therapeutically active compound or drug. In accordance with this example of the disclosure, the package insert is on or associated with the container. Suitable containers include, for example, bottles, vials, syringes, etc. The containers may be formed from a variety of materials such as glass or plastic. The container holds or contains a composition that is effective for treating, preventing and/or delaying progression of a condition and may have a sterile access port (for example, the container may be an intravenous solution bag or a vial having a stopper pierceable by a hypodermic injection needle). At least one active agent in the composition is the albumin solution. The label or package insert indicates that the composition is used for treating a subject eligible for treatment, with specific guidance regarding dosing amounts and intervals of the albumin solution and any other medicament being provided. The kit may further comprise an additional container comprising a pharmaceutically acceptable diluent buffer, such as bacteriostatic water for injection (BWFI), phosphate-buffered saline, Ringer's solution, and/or dextrose solution. The kit may further include other materials desirable from a commercial and user standpoint, including other buffers, diluents, filters, needles, and syringes. The kit optionally further comprises a container comprises a second medicament, wherein the albumin solution is a first medicament, and which article further comprises instructions on the package insert for treating the subject with the second medicament, in an effective amount. The second medicament may be a therapeutic protein. The invention is further disclosed in the following numbered paragraphs: 1. A method of heat treating a fraction V or an equivalent fraction thereof comprising albumin, the method comprising heating the fraction V or an equivalent fraction thereof at a temperature of between 70°C ± 0.2°C to 74°C ± 0.2°C for a period of between 30 seconds to 30 minutes, thereby producing a heat treated albumin solution. 2. A method of reducing proteolytic activity of a fraction V or an equivalent fraction thereof comprising albumin, the method comprising heating the fraction V or an equivalent fraction thereof at a temperature of between 70°C ± 0.2°C to 74°C ± 0.2°C for a period of between 30 seconds to 30 minutes, thereby producing an albumin solution with reduced proteolytic activity. 3. The method of paragraph 1 or paragraph 2, wherein: i) the temperature is between 70°C ± 0.2°C to 71°C ± 0.2°C and the period is between 1 to 30 minutes; ii) the temperature is 72°C ± 0.2°C and the period is between 1 to 20 minutes; ii) the temperature is 72.5°C ± 0.2°C and the period is between 1 to 12 minutes; iii) the temperature is 73°C ± 0.2°C and the period is between 1 to 3 minutes; or iv) the temperature is 74°C ± 0.2°C and the period is 50 seconds. 4. The method of any one of paragraphs 1 to 3, wherein the albumin solution comprises a purity of at least 95% albumin. 5. The method of any one of paragraphs 1 to 4, wherein the albumin solution comprises at least 85% albumin monomer. 6. The method of any one of paragraphs 1 to 5, wherein the albumin solution comprises less than 5% albumin aggregate. 7. The method of paragraph 5 or 6, wherein the percentage of albumin monomer and/or the percentage of albumin aggregate is determined using size-exclusion chromatography (SEC). 8. The method of any one of paragraphs 1 to 7, wherein the albumin solution has a turbidity of less than 0.5, 0.4, 0.3, 0.2 or 0.1 optical density at 320 nm (OD₃₂₀). 9. The method of paragraph 8, wherein the turbidity is determined using an optical absorbance detector. 10. The method of any one of paragraphs 1 to 9, wherein the albumin solution has a proteolytic activity of less than 2, 1.5, 1.0 or 0.5 milli optical density at 405 nm per minute (mOD₄₀₅/min). 11. The method of paragraph 10, wherein the proteolytic activity is determined using an assay kit selected from the group consisting of a thrombin activity assay kit, a general serine protease assay kit, a kallikrein activity assay kit, a plasmin activity assay kit, a FXa activity kit, and combinations thereof. 12. The method of any one of paragraphs 1 to 11, wherein the fraction V is a Cohn Fraction V (Fr V). 13. The method of any one of paragraphs 1 to 12, wherein the equivalent fraction thereof is Kistler/Nitschmann Precipitate C. 14. The method of any one of paragraphs 1 to 13, wherein the fraction V or equivalent fraction thereof comprises a purity of at least 95% albumin. 15. The method of any one of paragraphs 1 to 14, wherein the fraction V or equivalent fraction thereof does not comprise a detectable amount of ethanol. 16. The method of any one of paragraphs 1 to 15, wherein the fraction V or equivalent fraction thereof comprises at least one stabiliser. 17. The method of paragraph 16, wherein the stabiliser is sodium caprylate and/or N-acetyl- DL-tryptophan. 18. The method of paragraph 16 or 17, wherein the fraction V or equivalent fraction thereof comprises at least 0.07 mmol per gram of total protein of the stabiliser. 19. The method of any one of paragraphs 1 to 18, wherein the temperature is between 69.8°C to 70.2°C and the period is between 20.5 to 27.5 minutes. 20. The method of any one of paragraphs 1 to 19, wherein the temperature is between 69.8°C to 70.2°C and the period is 24 minutes. 21. The method of any one of paragraphs 1 to 20, wherein the method further comprises pasteurisation and/or terminal incubation of the albumin solution. 22. The method of paragraph 21, wherein pasteurisation comprises the step of heating the albumin solution to a temperature of 60°C for a period of about 10 hours. 23. The method of any one of paragraphs 1 to 22, wherein the method is performed as a batch process or the method is performed as a continuous process. 24. The method of any one of paragraphs 1 to 23, wherein the albumin is human serum albumin or bovine serum albumin. 25. A method of heat treating a fraction V or equivalent fraction thereof comprising albumin, the method comprising one or more rounds of heating the fraction V or equivalent fraction thereof at a temperature of: i) between 70°C ± 0.2°C to 71°C ± 0.2°C for a period of between 1 to 30 minutes; ii) 72°C ± 0.2°C and for a period of between 1 to 20 minutes; ii) 72.5°C ± 0.2°C and for a period of between 1 to 12 minutes; iii) 73°C ± 0.2°C and for a period of between 1 to 3 minutes; or iv) 74°C ± 0.2°C and for a period of 50 seconds, and one or more rounds of clarifying the fraction V or equivalent fraction thereof after heating the fraction V or equivalent fraction thereof, thereby producing a heat treated albumin solution. 26. The method of any one of paragraphs 1 to 25, wherein the fraction V or equivalent fraction thereof comprises 200 g/L or 250 g/L of albumin. 27. A pharmaceutical composition comprising the albumin solution produced by a method of any one of paragraphs 1 to 26. 28. The pharmaceutical composition of paragraph 27, wherein the pharmaceutical composition comprises a nominal osmolality of between 130 to 260 mOsm/kg. 29. The pharmaceutical composition of paragraph 27 or 28, wherein the pharmaceutical composition has a pH of between 6.7 and 7.3. 30. The pharmaceutical composition of any one of paragraphs 27 to 29, wherein the pharmaceutical composition comprises a prekallikrein activator (PKA) level of less than 35 IU/mL. 31. The pharmaceutical composition of any one of paragraphs 27 to 30, wherein the pharmaceutical composition comprises an aluminium content of less than 200 mcg/L. 32. The pharmaceutical composition of any one of paragraphs 27 to 31, wherein the pharmaceutical composition comprises a potassium content of less than 0.002 M. 33. The pharmaceutical composition of any one of paragraphs 27 to 32, wherein the pharmaceutical composition comprises 250 g/L of albumin, a nominal osmolality of 258 mOsm/kg, 20 mmol of sodium acetyltryptophanate, 20 mmol of sodium octanoate and a sodium content of 140 mmol/L. 34. The pharmaceutical composition of any one of paragraphs 27 to 32, wherein the pharmaceutical composition comprises 200 g/L of albumin, a nominal osmolality of 258 mOsm/kg, 16 mmol of sodium acetyltryptophanate, 16 mmol of sodium octanoate and a sodium content of 140 mmol/L. 35. The pharmaceutical composition of any one of paragraphs 27 to 32, wherein the pharmaceutical composition comprises 50 g/L of albumin, a nominal osmolality of 258 mOsm/kg, 4 mmol of sodium acetyltryptophanate, 4 mmol of sodium octanoate and a sodium content of 140 mmol/L. 36. The pharmaceutical composition of any one of paragraphs 27 to 32, wherein the pharmaceutical composition comprises 200 g/L of albumin, a nominal osmolality of 130 mOsm/kg, 32 mmol/L of octanoate and a sodium content of 48 to 100 mmol/L. 37. The pharmaceutical composition of any one of paragraphs 27 to 32, wherein the pharmaceutical composition comprises 40 g/L of albumin, a nominal osmolality of 260 mOsm/kg, 6.4 mmol/L of octanoate, 128 mmol/L of chloride and a sodium content of 140 mmol/L. 38. Use of the albumin solution produced by a method of any one of paragraphs 1 to 26 in the manufacture of a medicament for treating, preventing and/or delaying progression of a condition in a subject. 39. The pharmaceutical composition of any one of paragraphs 27 to 37, for use in treating, preventing and/or delaying progression of a condition in a subject. 40. A method of treating, preventing and/or delaying progression of a condition in a subject, the method comprising administering the pharmaceutical composition of any one of paragraphs 27 to 37 to the subject. 41. The use of paragraph 38, or the pharmaceutical composition of paragraph 39, or the method of paragraph 40, wherein the condition is selected from a group consisting of hypoproteinaemia, shock, burns, adult respiratory distress syndrome, haemodialysis, plasma exchange, cardiopulmonary bypass, acute liver failure, hypoalbuminemia, hypovolemia and combinations thereof. 42. A method of heat treating a fraction V or equivalent fraction thereof comprising albumin, the method comprising one or more rounds of heating the fraction V or equivalent fraction thereof at a temperature of: i) between 70°C ± 0.2°C to 71°C ± 0.2°C for a period of between 1 to 30 minutes; ii) 72°C ± 0.2°C and for a period of between 1 to 20 minutes; ii) 72.5°C ± 0.2°C and for a period of between 1 to 12 minutes; iii) 73°C ± 0.2°C and for a period of between 1 to 3 minutes; or iv) 74°C ± 0.2°C and for a period of 50 seconds, and one or more rounds of clarifying the fraction V or equivalent fraction thereof after heating the fraction V or equivalent fraction thereof, thereby producing a heat treated albumin solution, wherein the fraction V or equivalent fraction thereof comprises 50 g/L of albumin, 0.08 mmol per gram of total protein of sodium caprylate, 0.08 mmol per gram of total protein of N- acetyl-DL-tryptophan, at least 90% albumin monomer, a purity of at least 96% albumin and has a pH of between 6.7 and 7.3 measured at room temperature. 43. A method of heat treating a fraction V or equivalent fraction thereof comprising albumin, the method comprising one or more rounds of heating the fraction V or equivalent fraction thereof at a temperature of: i) between 70°C ± 0.2°C to 71°C ± 0.2°C for a period of between 1 to 30 minutes; ii) 72°C ± 0.2°C and for a period of between 1 to 20 minutes; ii) 72.5°C ± 0.2°C and for a period of between 1 to 12 minutes; iii) 73°C ± 0.2°C and for a period of between 1 to 3 minutes; or iv) 74°C ± 0.2°C and for a period of 50 seconds, and one or more rounds of clarifying the fraction V or equivalent fraction thereof after heating the fraction V or equivalent fraction thereof, thereby producing a heat treated albumin solution, wherein the fraction V or equivalent fraction thereof comprises 200 g/L of albumin, 0.08 mmol per gram of total protein of sodium caprylate, 0.08 mmol per gram of total protein of N-acetyl-DL-tryptophan, at least 90% albumin monomer, a purity of at least 96% albumin and has a pH of between 6.7 and 7.3 measured at room temperature. 44. A method of heat treating a fraction V or equivalent fraction thereof comprising albumin, the method comprising one or more rounds of heating the fraction V or equivalent fraction thereof at a temperature of: i) between 70°C ± 0.2°C to 71°C ± 0.2°C for a period of between 1 to 30 minutes; ii) 72°C ± 0.2°C and for a period of between 1 to 20 minutes; ii) 72.5°C ± 0.2°C and for a period of between 1 to 12 minutes; iii) 73°C ± 0.2°C and for a period of between 1 to 3 minutes; or iv) 74°C ± 0.2°C and for a period of 50 seconds, and one or more rounds of clarifying the fraction V or equivalent fraction thereof after heating the fraction V or equivalent fraction thereof, thereby producing a heat treated albumin solution, wherein the fraction V or equivalent fraction thereof comprises 250 g/L of albumin, 0.08 mmol per gram of total protein of sodium caprylate, 0.08 mmol per gram of total protein of N-acetyl-DL-tryptophan, at least 90% albumin monomer, a purity of at least 96% albumin and has a pH of between 6.7 and 7.3 measured at room temperature. The present disclosure includes the following non-limiting Examples. EXAMPLES Example 1: Materials and methods Albumin Bulk Material The albumin bulk material is a fraction V or equivalent fraction thereof comprising which is adjusted to a target protein concentration of 200 g/L or 250 g/L (±10 g/L) of albumin with a pH of 6.7 to 7.3 when measured at room temperature. The albumin bulk material also comprises sodium caprylate, which is determined as an in-process-control testing (≤ 2.9 g/L related to a 20% albumin solution). The measured value of remaining caprylate is then used to specifically calculate the additional amount of caprylate that needs to be added to adjust the solution to the defined caprylate concentration of 2.75 g/L (± 0.35 g/L) (resulting in 0.07 to 0.10 mmol per gram of total protein) before preliminary heating experiments were conducted. The percentage of albumin monomer in the albumin bulk material is around 93 to 97% (as measured by the SEC method according to Ph.Eur) and the purity is greater than 96% (as measured by agarose gel electrophoresis) with less than 4% of residual proteins (i.e., impurities). Preliminary heating experiments 1 mL of albumin bulk from a production batch was added to 1.8 mL cryo-tubes and 200μL PCR cups. These tubes/cups were then tempered in a temperature-controlled water bath at 70°C, 72°C, 72.5°C, 73°C, 74°C, 75°C, 76.5°C, 80°C, and 85°C for the intervals of 30 seconds to 30 minutes. Additional tubes/cups were tempered in a temperature-controlled water bath at 60°C for up to 10 hours to mimic the current bulk heating procedure, and a sample was taken every hour. The samples were fixed in foam floats to ensure optimal contact between the water and the sample. After the samples were removed from the water bath, they were placed directly in a room temperature water bath for 1 minute, then stored at 2-8°C. Proteolytic activity A GloMax® Discover Plater Reader (Promega) was used to measure proteolytic activity. Sample buffer (10 mM Tris-HCl and 0.5 M NaCl) was prepared using 1.2 g Tris-HCl and 29.24 g NaCl in 1 L of Milli-Q water, the pH adjusted to pH 7 using 5 M HCl and stored at -20°C. Prior to each assay, the sample buffer was thawed at 37°C in a water bath and 20% Human Serum Albumin (HSA; ~225 μL 20% HSA in 45 mL of buffer) was added. Substrate buffer (50 mM Tris-HCl and 0.15 M NaCl) was prepared using 6.04 g Tris- HCl and 8.76 g NaCl in 1 L of MQ water, the pH adjusted to pH 8 using 5 M HCl and stored at -20°C. Prior to each assay, the substrate buffer was thawed at 37°C in a water bath. The substrate buffer was used to reconstitute lyophilised S-2288 (Haemochrom general serine protease assay kit) and S-2302 (Haemochrom kallikrein activity assay kit) at a concentration of 0.6 mM. 50 µL of sample buffer was pipetted into a 96 well plate, followed by 50 µL of diluted albumin samples. For each experiment, sample buffer, substrate buffer and undiluted sample were used as controls. The wavelength was set to 405 nm and temperature at 37°C. The plate was covered and incubated in the Plate Reader at 37°C for 15 minutes. After incubation, S- 2288 or S-2302 was added by the plate reader and the plate was agitated for 10 seconds. Measurements were taken every 5 minutes for a period of 30 minutes. Optical density (OD) was measured taking into account dilution factors. Size exclusion chromatography (SEC) Running buffer was prepared by dissolving 11.68 g of table salt in 1.8 L of Milli-Q water, then adding 9.04 mL of 95% orthophosphoric acid and adjusting the pH to 7.2 with 2 M NaOH. Samples were diluted with PBS buffer to a concentration of 5 g/L. The UltiMate 3000 HPLC system (Thermo Scientific) was rinsed with the running buffer and the TSK G3000SW HPLC column (Tosoh) was calibrated. The samples were stored in the auto sampler at 7°C. Column temperature was 20°C. To control the analysis, the system suitability test (SST) control sample was also tested. This is applied in triplicate before and after the samples to be tested and, when measuring more than 15 samples, is also co-tested between the other samples for consistency. Samples and controls were separated isocratically over 30 minutes using the PBS buffer. The flow rate was 0.5 mL/min and the injected sample volume was 10 μL for the control and 5 μL for the samples. Detection of the fractions was performed photometrically in the ultraviolet range at 280 nm. SDS-PAGE SDS-PAGE was performed to identify any unusual protein fragments that may have been caused by extreme heating of albumin bulk. Samples were pre-diluted with isotonic saline to a concentration of 1 g/L. Non-reduced samples had 50 µL tris-glycine buffer added to a total volume of 100 µL. Reduced samples had 40 µL tris-glycine buffer and 10 µL reduction solution (20 mL Milli-Q water and 0.62 g DTT) added to a total volume of 100 µL. The samples were heated at 95°C for 10 minutes. 10 μL of sample and 5 μL of a protein standard were used. Electrophoretic separation was performed at 125 V for 75 minutes. Gels were placed in 100 mL of fixative solution for at least one hour, then stained in 100 mL Coomassie Blue for two to three hours at 70°C, under agitation. Three decolourisation steps were performed with 100 mL of Milli-Q water, each decolourisation step was for at least one hour. Turbidity A photometer was used to measure the turbidity of the samples. Samples were diluted 1:200 in two steps. The pre dilution was 1:10 and the second dilution step was 1:20. A wavelength of 280 nm and 320 nm was used. The absorbance at a wavelength of 320 nm (representative for the turbidity of the sample) is subtracted from the absorbance at 280 nm to determine the protein concentration. Example 2: Identification of suitable parameters Preliminary heating experiments Figure 1 shows five different heat-treated samples with varying levels of aggregation and turbidity. Temperatures above 73°C were determined to be too high, unless only heated for short time periods, due to the high level of aggregation of the albumin. Figure 1C shows that even a minimal variance in temperature (e.g., 0.5°C) can have a significant impact on aggregation and turbidity. Table 1 illustrates the correlation between temperature and time on the turbidity of the albumin bulk. Table 1: Turbidity behaviour of albumin bulk at various conditions Proteolytic activity The proteolytic activity of bulk albumin was compared between the present experiments (samples taken every 5 minutes) (Figure 2) and the previously known method for bulk heating albumin (i.e., albumin bulk heated for 10 hours at 60°C, described herein as the “production method”) (samples taken every hour) (Figure 3). Inactivation of proteases by the higher temperature is at least 12 times faster than during common bulk heating. Size exclusion chromatography Fractions from the SEC of the bulk albumin are shown in Table 18. Aggregate content needs to remain below or equal to 5% in order for the albumin to be approved for market according to the Ph. Eur. Table 2: SEC results of different conditions 15 73 5 96.6 0.5 0.2 2.5 2.5 Example 3: Further experiments Samples Two different batches (i.e., P100470852 and P100470856) of albumin bulk from production were used as sample material. These batches were processed according to the same manufacturing procedures, however, differences in various process parameters (e.g., long filter aid contact times) resulted in differences in protease levels present between the batches. The conditions for the heating experiments shown in Table 3 and are distributed over the entire temperature range for both batches. Table 3: Sample conditions Albumin bulk was procured from the production before and after standardised bulk heating for comparisons and the results are summarised in Table 4. Table 4: Summarized results of the initial value and production Overall Experimental Design Based on the data from the preliminary tests (see Examples 1 and 2), models for further testing were developed using JMP software. Models were based on two independent variables (i.e., temperature and time) and four dependent variables (i.e., percentage of albumin monomer, percentage of albumin aggregate and proteolytic activity). Models were first created for each dependent variable individually as set out below. Experimental Design – Percentage of Albumin Monomer To study the effect of time and temperature on percentage of albumin monomer a model was designed based on the various parameters as set out in Table 5. All parameters, other than the quadratic effect of time, had a P-value of less than 0.1 and were included in the monomer model going forward. Table 5: Relationships and parameters considered for the monomer content model Source PValue The model was statistically tested by examining a scatterplot of the Actual by Predicted (Figure 4A), Residual by Predicted Plot (Figure 4B) and Studentised Residuals Plot (Figure 4C). Figure 4A shows no discernible pattern, Figure 4B shows an even distribution of residuals above and below the zero line and Figure 4C shows no outlier values. The model was then optimised for maximum desirability by addition of target values and analysed with the Prediction Profiler (Figure 5). Desired dependent variable target values were based on the results of the co-tested samples that were subjected to the production method and weighted for overall desirability (Table 4). For the percentage of albumin monomer, the target value was set to the mean of both batches (i.e., 94.2%). This target value was assigned a desirability factor of 1. The target values of 100% and 90% were each assigned a desirability factor of 0. The model predicted that 94.2% of albumin monomer is achieved at a relative time of -0.48 (i.e., 15 minutes) at a temperature of 70.06°C. The model predicts that a higher percentage of albumin monomer can be achieved at a relative time of 0.5 minutes at a temperature of 72.5°C. Experimental Design – Proteolytic Activity To study the effect of time and temperature on proteolytic activity a model was designed based on the various parameters set out in Tables 6 and 7. Only parameters with a P-value of less than 0.1 were included in the model going forward. Table 6: Relationships and parameters considered for the S-2288 model Source PValue Table 7: Relationships and parameters considered for the S-2302 model Source PValue The model was statistically tested by examining a scatterplot of the Actual by Predicted, Residual by Predicted Plot and Studentised Residuals Plot (not shown; no anomalies or outliers were found). The model was then optimised for maximum desirability by addition of target values and analysed with the Prediction Profiler (Figure 6). Desired dependent variable target values were based on the results of the co-tested samples that were subjected to the production method and weighted for overall desirability. For S-2288, 0.3 mOD/min was assigned a desirability factor of 0, 0.1 mOD/min was assigned a desirability factor of 0.5 and 0 mOD/min was assigned a desirability factor of 1. For substrate S-23020.5 mOD/min was assigned a desirability factor of 0, 0.2mOD/min was assigned a desirability factor of 0.5 and 0 mOD/min was assigned a desirability factor of 1. The model predicted a minimal proteolytic activity as detected by S-2288 at a relative time of 0.34 (i.e., 16.5 minutes) at a temperature of 71.1°C (Figure 6A). The model predicted minimum inactivation of proteolytic activity as detected by S-2288 after 2 minutes at 73°C. The model predicted a minimal proteolytic activity as detected by S-2302 at a relative incubation time of 0.53 (i.e., 17.5 minutes) at a temperature of 71.14°C (Figure 6B). The model predicted minimum inactivation of proteolytic activity as detected by S-2302 after 2 minutes at 73°C. Figure 6C illustrates the proteolytic activity as detected by S-2302 as a function of temperature and relative time. A value of 0.2 mOD/min was chosen as the high limit. This results in the grey area on the left in the figure. Based on the prediction of the model, a proteolytic activity of more than 0.2 mOD/min can be expected in this area. For the contour, an activity of 0.1 mOD/min was specified. For all conditions being located on this contour, a proteolytic activity of 0.1 mOD/min is predicted. The grey round area on the right of the blot shows a region where the activity theoretically lower than 0 mOD/min. Experimental Design – Monomer Peak Area To study the effect on monomer peak area a model was designed based on the various parameters as set out in Table 8. Only parameters with a P-value of less than 0.1 were included in the model going forward. Table 8: Relationships and parameters considered for the peak area model Source LogWorth PValue The model was statistically tested by examining a scatterplot of the Actual by Predicted, Residual by Predicted Plot and Studentised Residuals Plot (not shown; no anomalies or outliers were found). The model was then optimised for maximum desirability by addition of target values and analysed with the Prediction Profiler (Figure 7). Desired dependent variable target values were based on the results of the co-tested samples that were subjected to the production method and weighted for overall desirability. For the monomer peak area, the target value was set to the mean of both batches (i.e., 23.2 mOD*min). This target value was assigned a desirability factor of 1, and 24 mOD*min and 21 mOD*min were each assigned a desirability factor of 0.5. The model predicted a maximum value of 22.97 mOD*min for the peak area at a relative time of 1 (i.e., 30 minutes) at a temperature of 70°C. SDS-PAGE Samples for SDS-PAGE are shown in Table 9. Table 9: Representation of the applied sample in SDS-PAGE Each sample was analysed under non-reducing (gels A and C) and reducing (gels B and D) conditions. This analysis was undertaken to ensure there were no high molecular weight aggregates or fragments due to the decomposition of molecules undergoing extreme heating. The gels do not show any batch-dependent changes (Figure 8). Turbidity Turbidity was measured using a photometer. There were no differences between the two batches, and the difference of the initial (unheated) solution and the bulk heated sample from the production method was 0.0 OD. Accordingly, the turbidity illustrated Figure 9 was the result of the new heating method. For the samples that were generated twice under the same conditions, the mean value was calculated from the results and the standard deviation was included as an error in the diagram. Albumin Polymer Peak The albumin polymer peak was determined using size exclusion chromatography. It is an important release criterion for the albumin product and must not exceed 10%. The percentage of the albumin polymer is shown in Table 10. Before heating the albumin bulk, the percentage of the albumin polymer is 0%. Bulk heating results in formation of polymers and a corresponding peak in the chromatogram. Table 10: Percentage of the albumin polymer Interestingly, sample 26 demonstrates 0.3% albumin polymer following heating at 72°C for 12 minutes, whereas the monomer content is 99.2% prior to bulk heating. This indicates a higher purity of monomer content after bulk heating. Experimental Design – four dependent variables To study the effect on each dependent variable (i.e., percentage of albumin monomer, albumin monomer peak and proteolytic activity) a model was designed and evaluated based on the various parameters as set out in Table 11. Only parameters with a P-value of less than 0.1 were included in the model going forward. The model was statistically tested by examining a scatterplot of the Actual by Predicted, Residual by Predicted Plot and Studentised Residuals Plot (not shown; no anomalies or outliers were found). Table 11: Relationships and parameters considered for all responses Source PValue The model was then optimised for maximum desirability by addition of target values and analysed with the Prediction Profiler (Figure 10A). Desired dependent variable target values were as described above. Contour Profilers illustrate the results for each batch (Figures 10B and C). The model predicted that a temperature of 70.03°C for a time of about 24 minutes would result in the maximum desirability for each target value of each dependent variable. The model showed that there was tolerance for the time to fall between 20.5 to 27.5 minutes and maintain a high desirability for each target value of each dependent variable. The model also showed that there was tolerance for the temperature to fall between 69.8°C and 70.2°C and maintain a high desirability for each target value of each dependent variable. To confirm the model predictions, production batches of albumin were heated (Table 12). The results compared favourably with the outcomes of the production method (Figure 11). The dimer content of all heated samples was found to below that of the unheated samples (Figure 8C and D). Table 12: Summarised Results from Batch P100470852 (1) and Batch P100470856 (2)

Claims

CLAIMS 1. A method of heat treating a fraction V or an equivalent fraction thereof comprising albumin, the method comprising heating the fraction V or an equivalent fraction thereof at a temperature of between 70°C ± 0.2°C to 74°C ± 0.2°C for a period of between 30 seconds to 30 minutes, thereby producing a heat treated albumin solution. 2. The method of claim 1, wherein: i) the temperature is between 70°C ± 0.2°C to 71°C ± 0.2°C and the period is between 1 to 30 minutes; ii) the temperature is 72°C ± 0.2°C and the period is between 1 to 20 minutes; iii) the temperature is 72.5°C ± 0.2°C and the period is between 1 to 12 minutes; iv) the temperature is 73°C ± 0.2°C and the period is between 1 to 3 minutes; or v) the temperature is 74°C ± 0.

2°C and the period is 50 seconds.

3. The method of claim 1 or claim 2, wherein the albumin solution comprises: a purity of at least 95% albumin; at least 85% albumin monomer; and/or less than 5% albumin aggregate; for example, wherein the percentage of albumin monomer and/or the percentage of albumin aggregate is determined using size-exclusion chromatography (SEC). 4. The method of any one of claims 1 to 3, wherein the albumin solution has a turbidity of less than 0.5, 0.

4, 0.3, 0.2 or 0.1 optical density at 320 nm (OD₃₂₀), for example, wherein the turbidity is determined using an optical absorbance detector. 5. The method of any one of claims 1 to 4, wherein the albumin solution has a proteolytic activity of less than 2, 1.5, 1.0 or 0.

5 milli optical density at 405 nm per minute (mOD₄₀₅/min), for example, wherein the proteolytic activity is determined using an assay kit selected from the group consisting of a thrombin activity assay kit, a general serine protease assay kit, a kallikrein activity assay kit, a plasmin activity assay kit, a FXa activity kit, and combinations thereof.

6. The method of any one of claims 1 to 5, wherein the fraction V is a Cohn Fraction V (Fr V).

7. The method of any one of claims 1 to 6, wherein the equivalent fraction thereof is Kistler/Nitschmann Precipitate C.

8. The method of any one of claims 1 to 7, wherein the fraction V or equivalent fraction thereof: comprises a purity of at least 95% albumin; does not comprise a detectable amount of ethanol; and/or comprises at least one stabiliser, for example, wherein the stabiliser is sodium caprylate and/or N-acetyl-DL-tryptophan, and/or wherein the fraction V or equivalent fraction thereof comprises at least 0.07 mmol per gram of total protein of the stabiliser.

9. The method of any one of claims 1 to 8, wherein: (i) the temperature is between 69.8°C to 70.2°C and the period is between 20.5 to 27.5 minutes or the temperature is between 69.8°C to 70.2°C and the period is 24 minutes; (ii) the method further comprises pasteurisation and/or terminal incubation of the albumin solution, for example, wherein the pasteurisation comprises the step of heating the albumin solution to a temperature of 60°C for a period of about 10 hours; and/or (iii) the method is performed as a batch process or the method is performed as a continuous process.

10. The method of any one of claims 1 to 9, wherein the albumin is human serum albumin or bovine serum albumin.

11. The method of any one of claims 1 to 10, wherein the fraction V or equivalent fraction thereof comprises 200 g/L or 250 g/L of albumin.

12. A pharmaceutical composition comprising the albumin solution produced by a method of any one of claims 1 to 11.

13. The pharmaceutical composition of claim 12, wherein the pharmaceutical composition comprises: a nominal osmolality of between 130 to 260 mOsm/kg; a pH of between 6.7 and 7.3; a prekallikrein activator (PKA) level of less than 35 IU/mL; an aluminium content of less than 200 mcg/L; and/or a potassium content of less than 0.002 M.

14. The pharmaceutical composition of claim 12 or claim 13, wherein the pharmaceutical composition comprises: acetyltryptophanate, 20 mmol of sodium octanoate and a sodium content of 140 mmol/L; 200 g/L of albumin, a nominal osmolality of 258 mOsm/kg, 16 mmol of sodium acetyltryptophanate, 16 mmol of sodium octanoate and a sodium content of 140 mmol/L; 50 g/L of albumin, a nominal osmolality of 258 mOsm/kg, 4 mmol of sodium acetyltryptophanate, 4 mmol of sodium octanoate and a sodium content of 140 mmol/L; 200 g/L of albumin, a nominal osmolality of 130 mOsm/kg, 32 mmol/L of octanoate and a sodium content of 48 to 100 mmol/L; or 40 g/L of albumin, a nominal osmolality of 260 mOsm/kg, 6.4 mmol/L of octanoate, 128 mmol/L of chloride and a sodium content of 140 mmol/L.

15. The pharmaceutical composition of any one of claims 12 to 14, for use in treating, preventing and/or delaying progression of a condition in a subject, for example, wherein the condition is selected from a group consisting of hypoproteinaemia, shock, burns, adult respiratory distress syndrome, haemodialysis, plasma exchange, cardiopulmonary bypass, acute liver failure, hypoalbuminemia, hypovolemia and combinations thereof.