WO2026030152A1 - System and method for assessing transferability of a fill recipe - Google Patents

Abstract

A method for assessing transferability of a fill recipe includes collecting acceleration data of a needle of an off-line filler using an accelerometer, and collecting acceleration data of a needle of an online filler using another accelerometer. The method further includes calculating at least one of velocity, speed, or displacement data of the needle of each of the off-line filler and the online filler. The method also includes generating a graphical representation of at least one of the calculated velocity, speed, or displacement data of the needle of the off-line filler relative to the at least one of the calculated velocity, speed, or displacement data of the needle of the online filler by overlaying the at least one of the calculated velocity, speed, and displacement data to identify any data discrepancy. The method still further includes adjusting at least one parameter of the fill recipe for transferring.

Description

SYSTEM AND METHOD FOR ASSESSING TRANSFERABILITY OF A FILL RECIPE

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of the filing date of U.S. Provisional Patent Application No. 63/676,853, filed July 29, 2024, which is hereby incorporated by reference in its entirety.

FIELD OF DISCLOSURE

[0002] The present disclosure generally relates to fill recipes for drug containers and, more particularly, a system and method of assessing the transferability of a fill recipe for a drug container between an off-line filler and a commercial online filler.

BACKGROUND

[0003] Drug product filling relies on a controlled flow of drug product to ensure product quality is maintained throughout a fill cycle. Typically, a robust fill recipe is developed on an off-line filler and transferred to a commercial or online filler. This technology transfer process ensures efficient line time use, especially for line time-constrained commercial fillers. Nozzle movement is one component of a user-input fill recipe that governs a speed at which the filling nozzle enters and exits a drug container. While many known off-line fillers utilize the same filling technology, machine specifications for a filling speed and nozzle movement are not aligned between off-line fillers and commercial line fillers. More generally, differences in manufacturer and specifications between off-line filler equipment and a commercial line filler equipment creates several challenges to successfully transfer an off-line filler fill recipe for a drug container to an online filler. For example, a lack of accurate understanding of nozzle, and thus needle, movement between different fill sites has many unwanted implications, such as fill nozzle submergence, filling outside of the drug container, and bubbles and/or turbulence due to varying nozzle speed.

[0004] In addition, in some conventional examples, a high-speed camera is coupled to the off-line filler and used to qualitatively assess fill quality and other parameters of the fill recipe that may be transferred to the online filler, for example. However, the data (e.g., relative to the off-line filler) collected by the high-speed camera is not precise and thus errors and/or at least various discrepancies affecting a fill occur when transferring the fill recipe to the online filler,

SUMMARY

[0005] In accordance with a first aspect, a method for assessing transferability of a fill recipe for a drug container is disclosed and comprises collecting acceleration data of a needle of an off-line filler during a fill using an accelerometer coupled to the offline filler, the fill performed according to a fill recipe. The method also comprises collecting acceleration data of a needle of an online filler during a fill using an accelerometer coupled to the online filler, the fill performed according to the fill recipe. The method still further includes calculating, via one or more processors, at least one of velocity, speed, or displacement data of the needle of the off-line filler during the fill and at least one of velocity, speed, or displacement data of the needle of the online filler during the fill. In addition, the method includes comparing at least one of the calculated velocity, speed, or displacement data of the needle of the off-line filler and at least one of the calculated velocity, speed, or displacement data of the needle of the online filler to identify any data discrepancy and/or alignment in one of the calculated velocity, speed, or displacement data The method still further includes adjusting at least one parameter of the fill recipe for transferring to one or more of the online filler or a different online filler using any data discrepancy.

[0006] In accordance with another aspect, a system for assessing transferability of a fill recipe for a drug container comprises an off-line filler having a needle, and an accelerometer coupled to a portion of the off-line filler and configured to collect acceleration data of the needle of the off-line filler during a fill. The system also includes a computing device coupled to the accelerometer and having at least one processor and a memory communicatively coupled to the processor. The memory includes computer-readable instructions that, when executed, cause the at least one processor to calculate at least one of velocity, speed, or displacement data of the needle of the off-line filler using the acceleration data collected by the accelerometer during the fill. The computer-readable instructions further cause the at least one processor to compare the at least one of the calculated velocity, speed, or displacement data of the needle of the off-line filler to at least one of a threshold velocity, speed, or displacement data, respectively, or at least one of a calculated velocity, speed, or displacement data, respectively, of a needle of an online filler during a fill.

[0007] In accordance with yet another aspect, a tangible, computer-readable medium storing instructions that when executed by one or more processors of a computing system cause the computer system to calculate at least one of velocity, speed, or displacement data of a needle of the off-line filler using the acceleration data collected by an accelerometer coupled to the off-line filler during the fill. In addition, the instructions further cause the computer system to generate a graphical representation of at least one of the calculated velocity, speed, or displacement data of the needle of the off-line filler relative to calculated velocity, speed, or acceleration data of a needle of an online filler for use with determining a fill recipe for the online filler. At least one of the calculated velocity, speed, or displacement data of the needle of the off-line filler is overlaying at least one of the calculated velocity, speed, or acceleration data, respectively, of the online filler to identify any data discrepancy to help adjust the fill recipe for transferring.

BRIEF DESCRIPTION OF THE DRAWINGS

[0008] It is believed that the disclosure will be more fully understood from the following description taken in conjunction with the accompanying drawings. Some of the drawings may have been simplified by the omission of selected elements for the purpose of more clearly showing other elements. Such omissions of elements in some drawings are not necessarily indicative of the presence or absence of particular elements in any of the example embodiments, except as may be explicitly delineated in the corresponding written description. Also, none of the drawings is necessarily to scale.

[0009] FIG. 1 is a block diagram depicting a system for assessing the transferability of a fill recipe for a drug container according to an aspect of the present disclosure.

[0010] FIG. 2 is a perspective view of a portion of an off-line filler of the system of FIG. 1;

[0011] FIG. 3 is a perspective view of a portion of an online filler of the system of FIG. 1;

[0012] FIG. 4A is a perspective view of a needle of the system of FIG. 1 in a basic needle position relative to a drug container;

[0013] FIG. 4B is another perspective view of the needle of the system of FIG. 1 relative to the drug container and in a start needle down position of a fill;

[0014] FIG. 4G is another perspective view of the needle of the system of FIG. 1 disposed within the drug container;

[0015] FIG. 4D is another perspective view of the needle of the system of FIG. 1 with the needle in a start needle up position relative to the drug container;

[0016] FIG. 4E is a perspective view of the needle of the system of FIG. 1 with the needle at an end of dosing or fill position;

[0017] FIG. 4F is a perspective view of the needle of the system of FIG. 1 with the needle back at the basic needle position when the fill is complete;

[0018] FIG. 5 is a graphical representation of a maximum main drive speed relative to vials per minute/per nozzle according to an exemplary fill recipe for each of the off-line filler and the online filler of the system of the present disclosure; [0019] FIG. 6 is a graphical representation of acceleration, velocity, and displacement data of the off-line filler of the system of the present disclosure according to a fill recipe;

[0020] FIG. 7 is another graphical representation of acceleration, velocity, and displacement data of the off-line filler of the system of the present disclosure according to another fill recipe;

[0021] FIG. 8 is a graphical representation of acceleration, velocity, and displacement data of the off-line filler of the system of the present disclosure according to a yet another fill recipe;

[0022] FIG. 9A is a graphical representation of pump speed relative to time overlaid for each of the off-line filler and the online filler according to the same fill recipe;

[0023] FIG. 9B is another graphical representation of pump speed relative to time overlaid for each of the off-line filler and the online filler according to another fill recipe;

[0024] FIG. 9C is another graphical presentation of pump speed relative to time overlaid for each of the off-line filler and the online filler according to yet another fill recipe;

[0025] FIG. 10 is a chart depicting needle movement offset for transfer of a fill recipe from the off-line filler to the online filler, the off-line filler and the online filler having different reference positions in the fill recipes for some parameters of the fill recipe;

[0026] FIG. 11 is a flow chart depicting various parameters of the fill of the drug container for the off-line filler;

[0027] FIG. 12 is a flow chart depicting various parameters of the fill of the drug container for the online filler;

[0028] FIG. 13 is a graphical representation including an overlay of each of the acceleration, velocity and displacement data for each of the off-line filler and the online filler according to the methods of the present disclosure; and

[0029] FIG. 14 is a chart depicting a fill recipe of the off-line filler transferred to the online filler with some adjustments made to the fill recipe for the online filler.

DETAILED DESCRIPTION

[0030] Generally, a system and method for assessing the transferability of a fill recipe for a drug container is disclosed. In one example, the method comprises collecting acceleration data of a needle of an off-line filler during a fill using an accelerometer coupled to a portion of the off-line filler, and the fill is conducted according to a certain fill recipe. The method also comprises collecting acceleration data of a needle of an online filler during a fill using an accelerometer coupled to the online filler, the fill performed according to the fill recipe. The method also includes calculating, via one or more processors, at least one of velocity, speed, or displacement data of the needle of the off-line filler during the fill and then comparing at least one of the calculated velocity, speed, or displacement data of the needle of the off-line filler and at least one of the calculated velocity, speed, or displacement data of the needle of the online filler to identify any data discrepancy and/or alignment in one of the calculated velocity, speed, or displacement data. The method still further comprises adjusting the fill recipe for transferring to one or more of the online filler or a different online filler using any identified data discrepancy in the overlay.

[0031] Referring now to Fig. 1, a system 10 for assessing transferability of a fill recipe for a drug container comprises an offline filler 12 having a needle 13A. An accelerometer 13B is coupled to a portion of the off-line filler 12 and configured to collect acceleration data of the needle 13A of the off-line filler 12 during a fill according to a fill recipe, as explained more below. In one example, the off-line filler 12 is a Bausch+Strobel™ B6 VarioSys™ filler, and in another example the off-line filler 12 is a Bausch+Strobel™ B6 Benchtop filler. Several other off-line fillers with varying needle movement speeds, such as still others made by Bausch+Strobel™, may alternatively be used and still fall within the scope of the present disclosure. As one of ordinary skill in the art will understand, the off-line filler 12 may include one or more of a pilot plant filler, a filler that is not within a filling line of a manufacturing plant, and/or a bench top filler. In one example, the off-line filler 12 is a bench top off-line filler that is scaled down version of the online filler 14. The bench top off-line filler of this example would typically have 1 to 2 filling nozzles for characterization purposes while the online filler 14 would have 10 to 20 nozzles for commercial production. The bench top offline filler would have similar H Ml , control logic, and algorithms compared to the online filler but not identical and therefore require additional characterization tools, e.g., the accelerometer, to compensate for the differences.

[0032] In some examples, the system 10 for assessing transferability of a fill recipe for a drug container may also include an online filler 14 having at least one needle 15A, as depicted in Fig. 1 and explained more below. In this example, another accelerometer 15B is coupled to a portion of the online filler 14. The accelerometer 15B is configured to collect acceleration data of the at least one needle 15A of the online filler 14 during a fill and according to the fill recipe, such as the fill recipe used for the fill of the off-line filler 12, as also explained more below. In one example, the online filler 14 is a Production Module 2 (PM2) Isolator Vial Filling Line (IVFL), which is a clinical or commercial line and a line time-constrained filler having a plurality of needles and drug containers, such as vials. Several other known online fillers with varying needle movement speeds, and others made by Bausch+Strobel, may alternatively be used and still fall within the scope of the present disclosure. The online filler 14 may generally include a filling line used in multiple biologies manufacturing plants and/or sites, for example, and/or a filler 14 disposed within a manufacturing line.

[0033] The system 10 for assessing transferability of a fill recipe for a drug container also comprises a computing system 16. The computing system 16 includes at least one computing device 18 that is coupled to one or both of the accelerometers, 13B and 15B, coupled to the off-line filler 12 and the online filler 14, respectively. The computing device 18 includes at least one memory device (M) 20, such as a memory device for data storage, at least one processor (P) 22 executable by the at least one memory device 20, a user interface(UI) 24, which may include a graphical user interface (GUI) 26, a network interface 28 (Nl) for connection with a wireless network 30 or a wired network, for example, and a Bluetooth (B) interface 35. The at least one processor 22 may be a general processor, a digital signal processor, ASIC, field programmable gate array, graphics processing unit, analog circuit, digital circuit, or any other known or later developed processor. The at least one processor 22 may operate pursuant to a profile stored in the memory device 20 of the computing device 18, for example. The at least one processor 22 may also include one or more processors, for example. The at least one memory device 20 may be a volatile memory or a nonvolatile memory. In addition, the at least one memory device 20 may include one or more of a read-only memory (“ROM”), random-access memory (“RAM”), a flash memory, an electronic erasable program read-only memory (“EEPROM”), or other type of memory. Further, the memory device 20 may include optical storage, magnetic storage (hard drive), or any other form of data storage. In addition, in other examples, the at least one processor 22 may be a combination of a primary processor and a coprocessor, e.g., x86 or x64 CPU for handling GUI, data storage, logging, and other operations, and a DSP for software-based hardware control. The computing device 18 further includes a receiver (R) 32 and a transmitter (T) 34.

[0034] In one example, the memory device 20 of the computing device 18 may include software and/or computer-readable instructions stored therein and be communicatively coupled to the at least one processor 22 that, when executed, cause the at least one processor 22 to calculate at least one of velocity, speed, or displacement data of the needle 13A of the off-line filler 12 using acceleration data collected by the accelerometer 13B during the fill of the off-line filler 12. The at least one processor 22 then compares the at least one calculated velocity, speed, or displacement data of the off-line filler 12 to at least one of threshold velocity, speed, or displacement data, respectively, or at least one of calculated velocity, speed, or displacement data, respectively, of the needle 15A of the online filler 14, for example, during a fill and based on the acceleration data collected by the accelerometer 15B coupled to the online filler 14 to identify any data discrepancy for adjusting the fill recipe to be transferred to the online filler. This discrepancy identified may then be used to adjust the fill recipe for transferring to the online filler 14 or a different online filler, for example. In one example, the at least one processor 22 may optionally generate a graphical representation of at least one of the calculated velocity, speed, or displacement data of the needle 13B of the off-line filler 12 and one of the threshold velocity, speed, or displacement data or at least one of the calculated velocity, speed, and displacement data of the needle 15A of the online filler 14 for use with determining a fill recipe for the online filler 14. The graphical representation is generated on the graphical user interface 26 of the computing device 18, for example. In the graphical representation, at least one of the calculated velocity, speed, or displacement data of the needle 13A of the off-line filler 12 overlays at least one of the threshold velocity, speed, or displacement data or the at least one calculated velocity, speed, or displacement data of the online filler 14.

[0035] Referring now to Fig. 2, a perspective view of a portion of an exemplary off-line filler 12 according to the present disclosure is depicted. The portion of the off-line filler 12 includes a needle filling arm 40 coupled to a vertical member 42 on which a nozzle 44 holding the needle 13A (not shown) is disposed. During operation of the off-line filler 12, such as during a fill, the vertical member 42 and thus the nozzle 44 move together along a length of a longitudinal axis X of the vertical member 42 to which the needle filling arm 40 is coupled. As a result, the needle filling arm 40 moves in the same direction and along the same longitudinal axis X as the nozzle 44. In this example, the accelerometer 13B of the off-line filler 12 is coupled to the needle filling arm 40 and is thus able to collect data related to movement of the needle filling arm 40 and nozzle 44 to which the needle 13A is coupled, such as acceleration data relative to the needle 13A of the off-line filler 12. While the accelerometer 13B is coupled to the needle filling arm 40 in this example, it will be appreciated that the accelerometer 13B may alternatively be coupled to another component of the off-line filler 12, such as a component that is coupled to the needle filling arm 40 and moveable with the needle filling arm 40, and still fall within the scope of the present disclosure. In another example, a high-speed camera (Fig. 1) 46 may also be used with the accelerometer 13B in collecting acceleration data of the needle 13A of the off-line filler 12. In this example, having precise accelerometer measurements enhances the value of videos from the high-speed camera 46 to quantify needle movement, for example.

[0036] Referring now to Fig. 3, a portion of the online filler 14 of the present disclosure is depicted. The online filler 14 includes a needle filling arm 52 to which the accelerometer 15B is coupled and on which at least one nozzle 54 holding the needle 15A is disposed. During operation of the online filler 14, such as during a fill, the needle filling arm 52 and thus the nozzle 54 to which the needle 15A is connected move together in a vertical direction, such as an up and down movement, enabling the accelerometer 15B to collect data related to the needle filling arm 52, the nozzle 54 and thus the needle 15A coupled thereto, such as acceleration data relative to the needle 15A of the online filler 14. While the accelerometer 15B is coupled to the needle filling arm 52 in this example, it will be appreciated that the accelerometer 15B may alternatively be coupled to another component of the online filler 14, such as another component that is coupled to the needle filling arm 52 and moveable with the needle filling arm 52, and still fall within the scope of the present disclosure. In another example, a high-speed camera (Fig. 1) 47 may also be used with the accelerometer 15B in collecting acceleration data of the needle 15A of the online filler 14. As further depicted in Fig. 3, the online filler 14 may include a plurality of nozzles 56 coupled to the needle filling arm 52, and each nozzle 54 of the plurality of nozzles 56 may include a needle 15A. In this example, the accelerometer 15B is able to collect data relative to each nozzle 54 and needle 15A coupled thereto of the online filler 14 during the fill.

[0037] In one example, the accelerometers 13B and 15B coupled to each of the off-line filler 12 and the online filler 14, respectively, are each a WitMotion Intertial Measurement Unit (IMU), WT901CTTL). This IMU is capable of measuring acceleration, angular velocity, angle, and magnetic field, for example, and includes an output frequency of 0.2-200Hz. In addition, this IMU has an acceleration range of +/- 16g, an acceleration resolution of 0.005g, and a battery length of approximately 4 hours. The IMU is Bluetooth enabled, which allows the accelerometers 13B and 15B to collect data relative to the needles 13A and 15A and transmit the same to the computing system 16 for use with further calculations in the methods described herein, for example.

[0038] Referring now to Figs. 4A-4F, a drug container 60, such as a vial, used in the off-line filler 12 of the present disclosure is depicted. The needle 13A of the off-line filler 12 is depicted at various stages and positions of the fill. Specifically, in Fig. 4A the needle 13A is depicted at a basic needle position in the filler 12 at which the needle 13A is in a position disposed above the drug container 60 such that the needle 13A is not disposed within the drug container 60. Once the fill begins, the needle 13A is moved, e.g., via the needle filling arm, in a vertical direction toward the drug container 60, such that the needle 13A is disposed within the drug container 60. In this start needle down position depicted in Fig. 4B, a tip of the needle 13A is disposed in approximately a central portion of the drug container 60. In Fig. 4C, the needle 13A is disposed further downward into the drug container 60 such the tip of the needle 13A is disposed in approximately a bottom portion of the drug container 60 and ready for the fill accordingly to the set fill recipe parameters.

[0039] As the fill progresses, the needle 13A is moved to a start needle up position, as depicted in Fig. 4D. In this position, the tip of the needle 13A is moved from the position near approximately the bottom portion of the drug container 60 and back to a position within the drug container 60 that is in an approximately central location of the drug container 60. At the end of the dosing and/or fill, the needle 13A is depicted in yet another position further from the central area of the drug container 60, as depicted in Fig. 4E. In this position, the tip of the needle 13A has been moved such that the tip of the needle 13A is now disposed closer to an opening of the drug container 60 in comparison of the position of the tip of the needle 13A in the start needle up position of Fig. 4D. Lastly, the needle 13A is moved back to the basic and/or initial position, as depicted in Fig. 4F. In this position, the needle 13A is moved back to a position in which the needle 13A is disposed outside of the drug container 60. The accelerometer 13B of the off-line filler 12 is able to collect movement data, such as acceleration data, of the needle 13A at all the positions of the needle 13A during the fill, such as each of the positions represented in each of Figs. 4A-4F. This acceleration data may be used to calculate velocity and displacement data of the needle 13A, for example, which is used in developing the most accurate fill recipe of the online filler 14, for example, and other online fillers as well, as described more below.

[0040] In view of the foregoing, it will be appreciated that the system 10 may operate and/or be used to implement one or more of the following methods. Specifically, and according to one example, a method for assessing transferability of a fill recipe for the drug container 60 from the off-line filler 12 to the online filler 14, or another online filler, comprises first collecting acceleration data of the needle 13A of the off-line filler 12 during a fill using the accelerometer 13B coupled to the off-line filler 12, the fill according to a particular fill recipe. The method also comprises collecting acceleration data of the needle 15A of the online filler 14 during the fill using the accelerometer 15B coupled to the online filler 14, the fill according to the fill recipe. In one example, the fill recipe used for the fill of the off-line filler 12 is the same fill recipe used for the fill of the online filler 14.

[0041] In one example, and referring now to FIG. 5, a graphical representation, which may be depicted on the graphical user interface 26 of the system 10, for example, is depicted in which a maximum main drive speed relative to a vial per minute is depicted for each of the acceleration data collected for the off-line filler 12, a VarioSys Suite 4 in this example, and the online filler 14, a IVFL filler in this example. The needle speed for each of the off-line filler 12 and the online filler 14 mostly matches, however some speed differences occur. These mismatched speeds, along with other needle movement data calculated using the acceleration data collected by the accelerometers 13B and 15B, are taken into consideration during transfer of the fill recipe to the online filler 14 or another online filler and may also be used in adjusting fill recipes for other online fillers.

[0042] The method further comprises calculating, via the one or more processors 22 (Fig. 1), at least one of velocity, speed, or displacement data of the needle 13A of the off-line filler 12 during the fill using the collected acceleration data, and calculating at least one of velocity, speed, or displacement data of the needle 15A of the online filler 14 during the fill also using the collected acceleration data. In Figs. 6-8, individual data plots of collected acceleration data, calculated velocity data, and calculated displacement data for various fillers are depicted. For example, Fig. 6 depicts individual data plots for each of the collected acceleration data, the calculated velocity data, and the calculated displacement data, as explained more below, for the off-line filler 12. In this example, the off-line filler 12 is a Variosys model, with a 20R Vial, 7.7 mL Fill and at 73% main drive speed as part of the fill recipe. Fig. 7 depicts individual data plots again for each of the collected acceleration data, the calculated velocity data, and the calculated displacement data for the off-line filler 12. In this example, the off-line filler 12 is the Variosys model again, but with a 2R Vial, 0.75 mL Fill and at 100% MD (main drive speed) as part of the fill recipe. Fig. 8 depicts individual data plots of the collected acceleration data, the calculated velocity data, and the calculated displacement data for the off-line filler 12. In this example, the off-line filler is again Variosys model, but with a 5cc Vial, 0.764 mL Fill and at 100% MD (main drive speed) as part of the fill speed. As explained more below, at least one of the acceleration data, calculated velocity data, or calculated displacement data of the off-line filler 12 of the system 10 of the present disclosure is overlaid with at least one of the acceleration data, calculated velocity data, and calculated displacement data of the online filler 14 to compare needle movement. Any discrepancy is then used to adjust the fill recipe for the online filler 14 or another online filler going forward.

[0043] In one example, calculating, via the one or more processors 22, at least one of velocity, speed, or displacement data of the needle 13A of the off-line filler 12 during the fill and at least one of the velocity, speed, or displacement data of the needle 15A of the online filler 14 during the fill comprises calculating the velocity data of the needle 13A of the off-line filler 12 and the needle 15A of the online filler 14 and then detrending the collected acceleration data of each of the off-line filler 12 and the online filler 14 to remove drift by selecting an interval of time of the collected acceleration data for at least one of the off-line filler 12 and the online filler 14. A linear fit is then applied to the collected acceleration data of each of the off-line filler 12 and the online filler 14 at the same interval of time and then along an entire period of time of the collected acceleration data according to the interval of time. In one example, the interval of time is two seconds and the entire period of time is 20 seconds. Said another way, the linear fit is applied to the collected acceleration data of each of the off-line filler 12 and the online filler 14 every two seconds (the interval of time) for a twenty second period of time (the entire time period). In this way, drift and other small errors the accelerometers 13B, and 15B are subject to in recording the acceleration data that is used in calculating the velocity of the needles 13A and 15A are removed and/or minimized and a more accurate calculated velocity based on the collected acceleration data from the accelerometers 13B and 15B is obtained. The detrending is a linear fit of the data points spanning the two second interval of time, e.g., detrending operation for a short segment of data. In another example, the method further comprises calculating, via the one or more processors 22, displacement data of the needles 13A and 15A of each of the off-line filler 12 and the online filler 14 during the fill by integrating the calculated velocity data of each of the off-line filler 12 and the online filler 14. In one example, and in this example, integrating is defined as using a mathematical trapezoid rule to calculate the area under the function/change in velocity over time for each of the off-line filler 12 and the online filler 14.

[0044] The method also includes comparing at least one of the calculated velocity, speed, or displacement data of the needle 13A of the off-line filler 12 and at least one of the calculated velocity, speed, or displacement data of the needle 15A of the online filler 14 to identify any data discrepancy and/or alignment in one of the calculated velocity, speed, or displacement data. The method also then includes adjusting the fill recipe for transferring to one or more of the online filler 14 or a different online filler using any data discrepancy to update the fill recipe for a more accurate fill.

[0045] In one example, comparing at least one of the calculated velocity, speed, or displacement data of the needle 13A of the off-line filler 12 and at least one of the calculated velocity, speed, or displacement data of the needle 15A of the online filler 14 to identify any data discrepancy and/or alignment in one of the calculated velocity, speed, or displacement data may comprise generating, via the one or more processors 22, a graphical representation of at least one of the calculated velocity, speed, or displacement data of the needle 13A of the off-line filler 12 relative to at least one of the calculated velocity, speed, or displacement data, respectively, of the needle 15A of the online filler 14 on the graphical user interface 26 of the computing system 16, for example. In this example, at least one of the calculated velocity, speed, or displacement data of the needle 13A of the off-line filler 12 is overlaid with at least one of the calculated velocity, speed, or displacement data of the online filler 14 to identify any data discrepancy and/or misalignment.

[0046] In one example, the method may further comprise confirming or assessing the transferability of the fill recipe for the offline to online filler, which includes overlaying at least one of collected acceleration data, calculated speed, calculated velocity and/or calculated displacement data of the needle 13A of the off-line filler 12 relative to at least one of collected acceleration data, calculated speed, calculated velocity and/or calculated displacement data of the needle 15A of the online filler 14 via the graphical representation. In another example, the method of confirming or assessing the transferability of the fill recipe for the off-line filler may include overlaying at least one of acceleration data and pump speed of a pump of the off-line filler 12 with at least one of acceleration data and pump speed of a pump of the online filler 14 via the graphical representation. For example, and referring to Figs. 9A-9C, Fig. 9A depicts a graphical representation in which the pump speed of the pump of the off-line filler 12 with 6R vial, 100% MD, and a fill volume of 1.274 mL as part of the fill recipe is overlaid with the pump speed of the pump of the online filler 14 using the same fill recipe. The online filler 14 (corresponds to the Factory Acceptance Testing or FAT legend on the graphical representation) has a slower filling speed than the off-line filler 12 (corresponds to B6 Reverse legend). Fig. 9B depicts a similar trend. Fig. 9B depicts a graphical representation in which the pump speed of the pump of the off-line filler 12 with 20R vial, 73% maximum main drive, and a fill volume of 7.696 mL as part of the fill recipe is overlaid with the pump speed of the pump of the online filler 14 using the same fill recipe. The online filler 14 (corresponds to the FAT legend on the graphical representation) again has a slower filling speed than the off-line filler 12 (corresponds to B6 Reverse legend). Fig. 9C depicts another graphical representation in which the pump speed of the pump of the off-line filler 12 with 30R vial, 61 % maximum main drive, and a fill volume of 7.404 mL as part of the fill recipe is overlaid with the pump speed of the pump of the online filler 14 using the same fill recipe. The online filler 14 (corresponds to the FAT legend on the graphical representation) again has a slower filling speed than the off-line filler 12 (corresponds to B6 Reverse legend). These parameters are observed and confirmed due to the overlaying of the data, allowing adjustments to the various fill recipes to be made for the online filler 14, for example, for a more accurate fill.

[0047] For example, and referring now to Figs. 10-12, one or more adjustments, which may be referred to as an offset, for parameters of the fill recipe, such as parameters related to the movement of the needle 15A for fill recipe for the online filler 14, may be needed relative to the same parameters for the movement of the needle 13A for the fill recipe for the off-line filler 12 after identifying one or more discrepancies in the overlay. Specifically, for a needle setting dimension parameter of the fill recipe, the reference position of the online filler 14 is above the drug container or vial 60, as depicted in Fig. 12, while the reference position of the off-line filler 12 is a base 62 of the drug container of vial 60, as depicted in Fig. 11. In addition, for the basic needle position, the reference position for the online filler 14 is a container rim 64, as depicted in Fig. 12, while the reference position of the off-line filler 12 is the base 62, as depicted in Fig. 11. The same is true for the needle down parameter and the needle at the end of dosing parameter, as indicated in the table of Fig. 10, for example.

[0048] Fig. 10 depicts a chart of nomenclature used for a fill recipe for the online filler 14, such an IVFL online filler, alongside nomenclature used for a fill recipe of the off-line filler 12, e.g., a Variosys off-line filler. The chart further includes a column comparing the machine logic difference between each of the online filler 14 and the off-line filler 12, indicating how the reference positions for each of the online filler 14 and the off-line filler 12 vary. Fig. 11 depicts a flow chart of various reference positions of the needle 13A of the off-line filler 12 during a fill, including the reference position of the needle 13A relative to the drug container or the vial 60 that is also depicted therein. The reference positions of the needle 13A of the off-line filler 12 of Fig. 11 further use the same or about the same nomenclature of the off-line filler 12 in the chart of Fig. 10. Fig. 12 depicts a flow chart of various reference positions of the needle 15A of the online filler 14 during a fill, including the reference position of the needle 15A relative to the drug container or the vail 60 that is also depicted therein. Similar to the reference positions of the needle 13A of the off-line filler of Fig. 11, the reference positions of the needle 15A of the online filler 14 of Fig. 12 also use the same or about the same nomenclature of the online filler 14 in the chart of Fig. 10.

[0049] In one example, generating, via the one or more processors 22, the graphical representation of at least one of the calculated velocity, speed, or displacement data of the needle 13A of the off-line filler 12 and at least one of the calculated velocity, speed, or displacement data of the needle 15A of the online filler 14, wherein at least one of the calculated velocity, speed, or displacement data of the needle 13A of the off-line filler 12 is overlaid with the at least one of the calculated velocity, speed, or displacement data of the needle 15A of the online filler 14 to identify any data discrepancy comprises comparing the calculated velocity data of the needle 13A of the off-line filler 12 overlaid with the calculated velocity data of the needle 15A of the online filler 14. The method may then further include identifying at least one discrepancy between the calculated velocity data of the needle 13A of the off-line filter 12 and the needle 15A of the online filler 14.

[0050] In another example, a graphical representation including an overlay for each of the collected acceleration, the calculated velocity, and the calculated displacement data of the needle 13A of the off-line filler 12 relative to the collected acceleration, the calculated velocity, and the calculated displacement data of the needle 15A of the online filler 14 is depicted in Fig. 13. As indicated in the overlay of the collected acceleration data, the online filler 14, e.g., IVFL, of Fig. 13 accelerates slightly sooner. In addition, various reference positions of the needle 13A of the off-line filler 12 and the needle 15A of the online filler 15A may vary, as indicated, and should be and are considered when adjusting at least one or more than one parameter of a fill recipe to be transferred to the online filler 14.

[0051] In another example, adjusting the fill recipe for transferring to one or more of the online filler 14 or a different online filler using any data discrepancy to update the fill recipe for a more accurate fill comprises changing or updating one or more needle movement parameters and/or pump parameters of the online filler 14 based on a data discrepancy identified in overlaying at least one of the calculated velocity, speed, or displacement data of the off-line filler 12 and at least one of the calculated velocity, speed, or displacement data of the online filler 14. One example is depicted in Fig. 14 in which a fill recipe includes various needle movement parameters for the off-line filler 12, e.g., listed as Variosys in the chart of Fig. 14, and an adjusted fill recipe includes various needle parameters for the online filler 14, e.g., listed as IVFL in the chart of Fig. 14, based one or more data discrepancies identified in overlaying the data. For example, in this example, a maximum main drive speed parameter, a needle setting dimension parameter, a basic needle position parameter, a container end-position parameter, and a needle rise with filling level start parameter have all been updated and/or adjusted in the fill recipe for the online filler 14 compared to the fill recipe of the off-line filler 12. In addition, pump parameters to be adjusted include pump dosing speed parameter and a pump dosing stop ramp parameter, in one example.

[0052] In a manner similar to the calculating the velocity data of each of the needles 13A and 15A of the off-line filler 12 and the online filler 14, the method may optionally further include generating a graphical representation, such as on the graphical user interface 26 of the computing device 18 of the computing system 16 (Fig. 1), of the calculated displacement data of the needles 13A and 15A. In this example, the calculated displacement data of the needle 13A of the off-line filler 12 is overlaid with the calculated displacement data of the needle 15A of the online filler 14 to identify any data discrepancy that may be used in adjusting the fill recipe for the online filler 14, for example. [0053] At least in view of the foregoing, it will be appreciated that the system 10 and related methods of the present disclosure include several advantages. For example, the system 10 and methods show that collected needle movement acceleration, and subsequently calculated needle velocity and displacement based on the collected acceleration data by the accelerometers 13B and 15B, are shown to have good overlaps in the various overlays once the fill recipe is matched and/or adjusted between the off-line filler 12 and the online filler 14 using correct offsets. In addition, for future technology transfer recipes from known off-line fillers 12 to online fillers 14, the known off-line fillers 12 can provide the precise needle movement fill recipe for the online fillers 14 that should run similar to the fill recipe developed in the off-line filler 12, ensuring good quality filling during production.

[0054] The above description describes various system and methods of transferring a fill recipe for a drug container, such as a vial, with a drug product to an online filler. It should be clear that the system or methods can further comprise use of a drug product listed below with the caveat that the following list should neither be considered to be all inclusive nor limiting. The drug product will be contained in a reservoir. In some instances, the reservoir is a primary container that is either filled with the drug product. The primary container can be any known primary container types understood by a person having ordinary skill in the art, such as a vial, a cartridge, a syringe, or an ampoule, in one example.

[0055] For example, drug products that may be used with the methods disclosed herein may include colony stimulating factors, such as granulocyte colony-stimulating factor (G-CSF). Such G-CSF agents include, but are not limited to, Neupogen® (filgrastim) and Neulasta® (pegfilgrastim). In various other embodiments, the methods may use various pharmaceutical products, such as an erythropoiesis stimulating agent (ESA), which may be in a liquid or a lyophilized form. An ESA is any molecule that stimulates erythropoiesis, such as Epogen® (epoetin alfa), Aranesp® (darbepoetin alfa), Dynepo® (epoetin delta), Mircera® (methyoxy polyethylene glycol-epoetin beta), Hematide®, MRK-2578, INS-22, Retacrit® (epoetin zeta), Neorecormon® (epoetin beta), Silapo® (epoetin zeta), Binocrit® (epoetin alfa), epoetin alfa Hexal, Abseamed® (epoetin alfa), Ratioepo® (epoetin theta), Eporatio® (epoetin theta), Biopoin® (epoetin theta), epoetin alfa, epoetin beta, epoetin zeta, epoetin theta, and epoetin delta, as well as the molecules or variants or analogs thereof as disclosed in the following patents or patent applications, each of which is herein incorporated by reference in its entirety: U.S. Patent Nos. 4,703,008; 5,441,868; 5,547,933; 5,618,698; 5,621,080; 5,756,349; 5,767,078; 5,773,569; 5,955,422; 5,986,047; 6,583,272; 7,084,245; and 7,271,689; and PCT Publication Nos. WO 91/05867; WO 95/05465; WO 96/40772; WO 00/24893; WO 01/81405; and WO 2007/136752.

[0056] An ESA can be an erythropoiesis stimulating protein. As used herein, “erythropoiesis stimulating protein” means any protein that directly or indirectly causes activation of the erythropoietin receptor, for example, by binding to and causing dimerization of the receptor. Erythropoiesis stimulating proteins include erythropoietin and variants, analogs, or derivatives thereof that bind to and activate erythropoietin receptor; antibodies that bind to erythropoietin receptor and activate the receptor; or peptides that bind to and activate erythropoietin receptor. Erythropoiesis stimulating proteins include, but are not limited to, epoetin alfa, epoetin beta, epoetin delta, epoetin omega, epoetin iota, epoetin zeta, and analogs thereof, pegylated erythropoietin, carbamylated erythropoietin, mimetic peptides (including EMP1/hematide), and mimetic antibodies. Exemplary erythropoiesis stimulating proteins include erythropoietin, darbepoetin, erythropoietin agonist variants, and peptides or antibodies that bind and activate erythropoietin receptor (and include compounds reported in U.S. Publication Nos. 2003/0215444 and 2006/0040858, the disclosures of each of which is incorporated herein by reference in its entirety) as well as erythropoietin molecules or variants or analogs thereof as disclosed in the following patents or patent applications, which are each herein incorporated by reference in its entirety: U.S. Patent Nos. 4,703,008; 5,441,868; 5,547,933; 5,618,698; 5,621,080; 5,756,349; 5,767,078; 5,773,569; 5,955,422; 5,830,851; 5,856,298; 5,986,047; 6,030,086; 6,310,078; 6,391,633; 6,583,272; 6,586,398;

6,900,292; 6,750,369; 7,030,226; 7,084,245; and 7,217,689; U.S. Publication Nos. 2002/0155998; 2003/0077753; 2003/0082749; 2003/0143202; 2004/0009902; 2004/0071694; 2004/0091961; 2004/0143857; 2004/0157293; 2004/0175379; 2004/0175824; 2004/0229318; 2004/0248815; 2004/0266690; 2005/0019914; 2005/0026834; 2005/0096461; 2005/0107297; 2005/0107591; 2005/0124045; 2005/0124564; 2005/0137329; 2005/0142642; 2005/0143292; 2005/0153879; 2005/0158822; 2005/0158832; 2005/0170457; 2005/0181359; 2005/0181482; 2005/0192211; 2005/0202538; 2005/0227289; 2005/0244409; 2006/0088906; and 2006/0111279; and PCT Publication Nos. WO 91/05867; WO 95/05465; WO 99/66054; WO 00/24893; WO 01/81405; WO 00/61637; WO 01/36489; WO 02/014356; WO 02/19963; WO 02/20034; WO 02/49673; WO 02/085940; WO 03/029291; WO 2003/055526; WO 2003/084477; WO 2003/094858; WO 2004/002417; WO 2004/002424; WO 2004/009627; WO 2004/024761; WO 2004/033651; WO 2004/035603; WO 2004/043382; WO 2004/101600; WO 2004/101606; WO 2004/101611; WO 2004/106373; WO 2004/018667; WO 2005/001025; WO 2005/001136; WO 2005/021579; WO 2005/025606; WO 2005/032460; WO 2005/051327; WO 2005/063808; WO 2005/063809; WO 2005/070451; WO 2005/081687; WO 2005/084711; WO 2005/103076; WO 2005/100403; WO 2005/092369; WO 2006/50959; WO 2006/02646; and WO 2006/29094.

[0057] Examples of other pharmaceutical products that may be used with the methods disclosed herein may include, but are not limited to, antibodies such as Vectibix® (panitumumab), Xgeva™ (denosumab) and Prolia™ (denosamab); other biological agents such as Enbrel® (etanercept, TN F-receptor /Fc fusion protein, TNF blocker), Neulasta® (pegfilgrastim, pegylated filgastrim, pegylated G-CSF, pegylated hu-Met-G-CSF), Neupogen® (filgrastim , G-CSF, hu-MetG-CSF), and Nplate® (romiplostim); small molecule drugs such as Sensipar® (cinacalcet). The methods may also be used with a therapeutic antibody, a polypeptide, a protein or other chemical, such as an iron, for example, ferumoxytol, iron dextrans, ferric glyconate, and iron sucrose. The pharmaceutical product may be in liquid form, or reconstituted from lyophilized form.

[0058] Among particular illustrative proteins are the specific proteins set forth below, including fusions, fragments, analogs, variants or derivatives thereof: OPGL specific antibodies, peptibodies, and related proteins, and the like (also referred to as RANKL specific antibodies, peptibodies and the like), including fully humanized and human OPGL specific antibodies, particularly fully humanized monoclonal antibodies, including but not limited to the antibodies described in PCT Publication No. WO 03/002713, which is incorporated herein in its entirety as to OPGL specific antibodies and antibody related proteins, particularly those having the sequences set forth therein, particularly, but not limited to, those denoted therein: 9H7; 18B2; 2D8; 2E11; 16E1 ; and 22B3, including the OPGL specific antibodies having either the light chain of SEQ ID NO:2 as set forth therein in Figure 2 and/or the heavy chain of SEQ ID NO:4, as set forth therein in Figure 4, each of which is individually and specifically incorporated by reference herein in its entirety fully as disclosed in the foregoing publication;

[0059] Myostatin binding proteins, peptibodies, and related proteins, and the like, including myostatin specific peptibodies, particularly those described in U.S. Publication No. 2004/0181033 and PCT Publication No. WO 2004/058988, which are incorporated by reference herein in their entirety particularly in parts pertinent to myostatin specific peptibodies, including but not limited to peptibodies of the mTN8-19 family, including those of SEQ ID NQS:305-351, including TN8-19-1 through TN8-19-40, TN8-19 coni and TN8-19 con2; peptibodies of the mL2 family of SEQ ID NOS:357-383; the mL15 family of SEQ ID NOS:384- 409; the mL17 family of SEQ ID NQS:410-438; the mL20 family of SEQ ID NOS:439-446; the mL21 family of SEQ ID NOS:447- 452; the mL24 family of SEQ ID NOS:453-454; and those of SEQ ID NOS:615-631 , each of which is individually and specifically incorporated by reference herein in their entirety fully as disclosed in the foregoing publication;

[0060] IL-4 receptor specific antibodies, peptibodies, and related proteins, and the like, particularly those that inhibit activities mediated by binding of IL-4 and/or IL-13 to the receptor, including those described in PCT Publication No. WO 2005/047331 or PCT Application No. PCT/US2004/37242 and in U.S. Publication No. 2005/112694, which are incorporated herein by reference in their entirety particularly in parts pertinent to IL-4 receptor specific antibodies, particularly such antibodies as are described therein, particularly, and without limitation, those designated therein: L1 H1; L1 H2; L1 H3; L1 H4; L1 H5; L1 H6; L1 H7; L1 H8; L1 H9; L1 H10; L1 H11; L2H1; L2H2; L2H3; L2H4; L2H5; L2H6; L2H7; L2H8; L2H9; L2H10; L2H11; L2H12; L2H13; L2H14; L3H1; L4H1; L5H1; L6H1, each of which is individually and specifically incorporated by reference herein in its entirety fully as disclosed in the foregoing publication;

[0061] Interleukin 1-receptor 1 (“IL1-R1”) specific antibodies, peptibodies, and related proteins, and the like, including but not limited to those described in U.S. Publication No. 2004/097712, which is incorporated herein by reference in its entirety in parts pertinent to IL1-R1 specific binding proteins, monoclonal antibodies in particular, especially, without limitation, those designated therein: 15CA, 26F5, 27F2, 24E12, and 10H7, each of which is individually and specifically incorporated by reference herein in its entirety fully as disclosed in the aforementioned publication;

[0062] Ang2 specific antibodies, peptibodies, and related proteins, and the like, including but not limited to those described in PCT Publication No. WO 03/057134 and U.S. Publication No. 2003/0229023, each of which is incorporated herein by reference in its entirety particularly in parts pertinent to Ang2 specific antibodies and peptibodies and the like, especially those of sequences described therein and including but not limited to: L1(N); L1(N) WT; L1(N) 1 K WT; 2xL1(N); 2xL1(N) WT; Con4 (N), Con4 (N) 1 K WT, 2xCon4 (N) 1 K; L1C; L1C 1 K; 2xL1C; Con4C; Con4C 1 K; 2xCon4C 1 K; Con4-L1 (N); Con4-L1C; TN-12-9 (N); C17 (N); TN8-8(N); TN8-14 (N); Con 1 (N), also including anti-Ang 2 antibodies and formulations such as those described in PCT Publication No. WO 2003/030833 which is incorporated herein by reference in its entirety as to the same, particularly Ab526; Ab528; Ab531 ; Ab533; Ab535; Ab536; Ab537; Ab540; Ab543; Ab544; Ab545; Ab546; A551; Ab553; Ab555; Ab558; Ab559;

Ab565; AbFIAbFD; AbFE; AbFJ; AbFK; AbG1 D4; AbGC1 E8; AbH 1 C12; AblA1; AbIF; AbIK, AblP; and AblP, in their various permutations as described therein, each of which is individually and specifically incorporated by reference herein in its entirety fully as disclosed in the foregoing publication;

[0063] NGF specific antibodies, peptibodies, and related proteins, and the like including, in particular, but not limited to those described in U.S. Publication No. 2005/0074821 and U.S. Patent No. 6,919,426, which are incorporated herein by reference in their entirety particularly as to NGF-specific antibodies and related proteins in this regard, including in particular, but not limited to, the NGF-specific antibodies therein designated 4D4, 4G6, 6H9, 7H2, 14D10 and 14D11, each of which is individually and specifically incorporated by reference herein in its entirety fully as disclosed in the foregoing publication;

[0064] CD22 specific antibodies, peptibodies, and related proteins, and the like, such as those described in U.S. Patent No. 5,789,554, which is incorporated herein by reference in its entirety as to CD22 specific antibodies and related proteins, particularly human CD22 specific antibodies, such as but not limited to humanized and fully human antibodies, including but not limited to humanized and fully human monoclonal antibodies, particularly including but not limited to human CD22 specific IgG antibodies, such as, for instance, a dimer of a human-mouse monoclonal h LL2 gamma-chain disulfide linked to a human-mouse monoclonal h LL2 kappa-chain, including, but limited to, for example, the human CD22 specific fully humanized antibody in Epratuzumab, CAS registry number 501423-23-0;

[0065] IGF-1 receptor specific antibodies, peptibodies, and related proteins, and the like, such as those described in PCT Publication No. WO 06/069202, which is incorporated herein by reference in its entirety as to IGF-1 receptor specific antibodies and related proteins, including but not limited to the IGF-1 specific antibodies therein designated L1 H1, L2H2, L3H3, L4H4, L5H5, L6H6, L7H7, L8H8, L9H9, L10H10, L11 H11, L12H12, L13H13, L14H14, L15H15, L16H16, L17H17, L18H18, L19H19, L20H20, L21 H21, L22H22, L23H23, L24H24, L25H25, L26H26, L27H27, L28H28, L29H29, L30H30, L31 H31, L32H32, L33H33, L34H34, L35H35, L36H36, L37H37, L38H38, L39H39, L40H40, L41 H41, L42H42, L43H43, L44H44, L45H45, L46H46, L47H47, L48H48, L49H49, L50H50, L51 H51, L52H52, and IGF-1 R-binding fragments and derivatives thereof, each of which is individually and specifically incorporated by reference herein in its entirety fully as disclosed in the foregoing publication; [0066] Also among non-limiting examples of anti-IGF-1 R antibodies for use in the methods and compositions of the present invention are each and all of those described in:

[0067] (i) U.S. Publication No. 2006/0040358 (published February 23, 2006), 2005/0008642 (published January 13, 2005), 2004/0228859 (published November 18, 2004), including but not limited to, for instance, antibody 1A (DSMZ Deposit No. DSM ACC 2586), antibody 8 (DSMZ Deposit No. DSM ACC 2589), antibody 23 (DSMZ Deposit No. DSM ACC 2588) and antibody 18 as described therein;

[0068] (ii) PCT Publication No. WO 06/138729 (published December 28, 2006) and WO 05/016970 (published February 24, 2005), and Lu et al. (2004), J. Biol. Chem. 279:2856-2865, including but not limited to antibodies 2F8, A12, and IMC-A12 as described therein;

[0069] (iii) PCT Publication No. WO 07/012614 (published February 1, 2007), WO 07/000328 (published January 4, 2007), WO 06/013472 (published February 9, 2006), WO 05/058967 (published June 30, 2005), and WO 03/059951 (published July 24, 2003)

[0070] (iv) U.S. Publication No. 2005/0084906 (published April 21, 2005), including but not limited to antibody 7C10, chimaeric antibody C7C10, antibody h7C10, antibody 7H2M, chimaeric antibody *7C10, antibody GM 607, humanized antibody 7C10 version 1, humanized antibody 7C10 version 2, humanized antibody 7C10 version 3, and antibody 7H2HM, as described therein;

[0071] (v) U.S. Publication Nos. 2005/0249728 (published November 10, 2005), 2005/0186203 (published August 25, 2005), 2004/0265307 (published December 30, 2004), and 2003/0235582 (published December 25, 2003) and Maloney et al. (2003), Cancer Res. 63:5073-5083, including but not limited to antibody EM164, resurfaced EM164, humanized EM164, huEM164 v1.0, huEM164 v1.1, huEM164 v1.2, and huEM164 v1.3 as described therein;

[0072] (vi) U.S. Patent No. 7,037,498 (issued May 2, 2006), U.S. Publication Nos. 2005/0244408 (published November 30, 2005) and 2004/0086503 (published May 6, 2004), and Cohen, et al. (2005), Clinical Cancer Res. 11 :2063-2073, e.g., antibody CP-751,871, including but not limited to each of the antibodies produced by the hybridomas having the ATCC accession numbers PTA-2792, PTA-2788, PTA-2790, PTA-2791, PTA-2789, PTA-2793, and antibodies 2.12.1, 2.13.2, 2.14.3, 3.1.1, 4.9.2, and 4.17.3, as described therein;

[0073] (vii) U.S. Publication Nos. 2005/0136063 (published June 23, 2005) and 2004/0018191 (published January 29, 2004), including but not limited to antibody 19D12 and an antibody comprising a heavy chain encoded by a polynucleotide in plasmid 15H 12/19D12 HCA (y4), deposited at the ATCC under number PTA-5214, and a light chain encoded by a polynucleotide in plasmid 15H 12/19D12 LCF (K), deposited at the ATCC under number PTA-5220, as described therein; and

[0074] (viii) U.S. Publication No. 2004/0202655 (published October 14, 2004), including but not limited to antibodies PINT- 6A1, PINT-7 A2, PINT-7A4, PINT-7A5, PINT-7 A6, PINT-8A1, PINT-9A2, PINT-11A1, PINT-11A2, PINT-11A3, PINT-11A4, PINT- 11A5, PINT-11A7, PINT-11A12, PINT-12A1, PINT-12A2, PINT-12A3, PINT-12A4, and PINT-12A5, as described therein; each and all of which are herein incorporated by reference in their entireties, particularly as to the aforementioned antibodies, peptibodies, and related proteins and the like that target I GF- 1 receptors;

[0075] B-7 related protein 1 specific antibodies, peptibodies, related proteins and the like (“B7RP-1,” also is referred to in the literature as B7H2, ICOSL, B7h, and CD275), particularly B7RP-specific fully human monoclonal I gG2 antibodies, particularly fully human lgG2 monoclonal antibody that binds an epitope in the first immunoglobulin-like domain of B7RP-1, especially those that inhibit the interaction of B7RP-1 with its natural receptor, ICOS, on activated T cells in particular, especially, in all of the foregoing regards, those disclosed in U.S. Publication No. 2008/0166352 and PCT Publication No. WO 07/011941, which are incorporated herein by reference in their entireties as to such antibodies and related proteins, including but not limited to antibodies designated therein as follow: 16H (having light chain variable and heavy chain variable sequences SEQ ID NO:1 and SEQ ID NO:7 respectively therein); 5D (having light chain variable and heavy chain variable sequences SEQ ID NO:2 and SEQ ID NO:9 respectively therein); 2H (having light chain variable and heavy chain variable sequences SEQ ID NO:3 and SEQ ID NQ:10 respectively therein); 43H (having light chain variable and heavy chain variable sequences SEQ ID NO:6 and SEQ ID NO: 14 respectively therein); 41 H (having light chain variable and heavy chain variable sequences SEQ ID NO:5 and SEQ ID NO:13 respectively therein); and 15H (having light chain variable and heavy chain variable sequences SEQ ID NO:4 and SEQ ID NO: 12 respectively therein), each of which is individually and specifically incorporated by reference herein in its entirety fully as disclosed in the foregoing publication;

[0076] IL-15 specific antibodies, peptibodies, and related proteins, and the like, such as, in particular, humanized monoclonal antibodies, particularly antibodies such as those disclosed in U.S. Publication Nos. 2003/0138421; 2003/023586; and 2004/0071702; and U.S. Patent No. 7,153,507, each of which is incorporated herein by reference in its entirety as to IL-15 specific antibodies and related proteins, including peptibodies, including particularly, for instance, but not limited to, HuMax IL-15 antibodies and related proteins, such as, for instance, 146B7;

[0077] IFN gamma specific antibodies, peptibodies, and related proteins and the like, especially human IFN gamma specific antibodies, particularly fully human anti-IFN gamma antibodies, such as, for instance, those described in U.S. Publication No. 2005/0004353, which is incorporated herein by reference in its entirety as to IFN gamma specific antibodies, particularly, for example, the antibodies therein designated 1118; 1118*; 1119; 1121; and 1121*. The entire sequences of the heavy and light chains of each of these antibodies, as well as the sequences of their heavy and light chain variable regions and complementarity determining regions, are each individually and specifically incorporated by reference herein in its entirety fully as disclosed in the foregoing publication and in Thakur et al. (1999), Mol. Immunol. 36:1107-1115. In addition, description of the properties of these antibodies provided in the foregoing publication is also incorporated by reference herein in its entirety. Specific antibodies include those having the heavy chain of SEQ ID NO:17 and the light chain of SEQ ID NO:18; those having the heavy chain variable region of SEQ ID NO:6 and the light chain variable region of SEQ ID NO:8; those having the heavy chain of SEQ ID NO:19 and the light chain of SEQ ID NQ:20; those having the heavy chain variable region of SEQ ID NQ:10 and the light chain variable region of SEQ ID NO:12; those having the heavy chain of SEQ ID NO:32 and the light chain of SEQ ID NQ:20; those having the heavy chain variable region of SEQ ID NQ:30 and the light chain variable region of SEQ ID NO:12; those having the heavy chain sequence of SEQ ID NO:21 and the light chain sequence of SEQ ID NO:22; those having the heavy chain variable region of SEQ ID NO:14 and the light chain variable region of SEQ ID NO:16; those having the heavy chain of SEQ ID NO:21 and the light chain of SEQ ID NO:33; and those having the heavy chain variable region of SEQ ID NO:14 and the light chain variable region of SEQ ID NO:31, as disclosed in the foregoing publication. A specific antibody contemplated is antibody 1119 as disclosed in the foregoing U.S. publication and having a complete heavy chain of SEQ ID NO:17 as disclosed therein and having a complete light chain of SEQ ID NO:18 as disclosed therein;

[0078] TALL-1 specific antibodies, peptibodies, and the related proteins, and the like, and other TALL specific binding proteins, such as those described in U.S. Publication Nos. 2003/0195156 and 2006/0135431, each of which is incorporated herein by reference in its entirety as to TALL-1 binding proteins, particularly the molecules of Tables 4 and 5B, each of which is individually and specifically incorporated by reference herein in its entirety fully as disclosed in the foregoing publications;

[0079] Parathyroid hormone (“PTH”) specific antibodies, peptibodies, and related proteins, and the like, such as those described in U.S. Patent No. 6,756,480, which is incorporated herein by reference in its entirety, particularly in parts pertinent to proteins that bind PTH; [0080] Thrombopoietin receptor (“TPO-R”) specific antibodies, peptibodies, and related proteins, and the like, such as those described in U.S. Patent No. 6,835,809, which is herein incorporated by reference in its entirety, particularly in parts pertinent to proteins that bind TPO-R;

[0081] Hepatocyte growth factor (“HGF”) specific antibodies, peptibodies, and related proteins, and the like, including those that target the HGF/SF:cMet axis (HGF/SF:c-Met), such as the fully human monoclonal antibodies that neutralize hepatocyte growth factor/scatter (HGF/SF) described in U.S. Publication No. 2005/0118643 and PCT Publication No. WO 2005/017107, huL2G7 described in U.S. Patent No. 7,220,410 and OA-5d5 described in U.S. Patent Nos. 5,686,292 and 6,468,529 and in PCT Publication No. WO 96/38557, each of which is incorporated herein by reference in its entirety, particularly in parts pertinent to proteins that bind HGF;

[0082] TRAIL-R2 specific antibodies, peptibodies, related proteins and the like, such as those described in U.S. Patent No. 7,521,048, which is herein incorporated by reference in its entirety, particularly in parts pertinent to proteins that bind TRAIL-R2;

[0083] Activin A specific antibodies, peptibodies, related proteins, and the like, including but not limited to those described in U.S. Publication No. 2009/0234106, which is herein incorporated by reference in its entirety, particularly in parts pertinent to proteins that bind Activin A;

[0084] TGF-beta specific antibodies, peptibodies, related proteins, and the like, including but not limited to those described in U.S. Patent No. 6,803,453 and U.S. Publication No. 2007/0110747, each of which is herein incorporated by reference in its entirety, particularly in parts pertinent to proteins that bind TGF-beta;

[0085] Amyloid-beta protein specific antibodies, peptibodies, related proteins, and the like, including but not limited to those described in PCT Publication No. WO 2006/081171, which is herein incorporated by reference in its entirety, particularly in parts pertinent to proteins that bind amyloid-beta proteins. One antibody contemplated is an antibody having a heavy chain variable region comprising SEQ ID NO:8 and a light chain variable region having SEQ ID NO:6 as disclosed in the foregoing publication;

[0086] c-Kit specific antibodies, peptibodies, related proteins, and the like, including but not limited to those described in U.S. Publication No. 2007/0253951, which is incorporated herein by reference in its entirety, particularly in parts pertinent to proteins that bind c-Kit and/or other stem cell factor receptors;

[0087] OX40L specific antibodies, peptibodies, related proteins, and the like, including but not limited to those described in U.S. Publication No. 2006/0002929, which is incorporated herein by reference in its entirety, particularly in parts pertinent to proteins that bind OX40L and/or other ligands of the 0X40 receptor; and

[0088] Other exemplary proteins, including Activase® (alteplase, tPA); Aranesp® (darbepoetin alfa); Epogen® (epoetin alfa, or erythropoietin); GLP-1, Avonex® (interferon beta-1 a); Bexxar® (tositumomab, anti-CD22 monoclonal antibody); Betaseron® (interferon-beta); Campath® (alemtuzumab, anti-CD52 monoclonal antibody); Dynepo® (epoetin delta); Velcade® (bortezomib); MLN0002 (anti- a4B7 mAb); MLN1202 (anti-CCR2 chemokine receptor mAb); Enbrel® (etanercept, TNF-receptor /Fc fusion protein, TNF blocker); Eprex® (epoetin alfa); Erbitux® (cetuximab, anti-EGFR / HER1 / c-ErbB-1); Genotropin® (somatropin, Human Growth Hormone); Herceptin® (trastuzumab, anti-HER2/neu (erbB2) receptor mAb); Humatrope® (somatropin, Human Growth Hormone); Humira® (adalimumab); insulin in solution; Infergen® (interferon alfacon-1); Natrecor® (nesiritide; recombinant human B-type natriuretic peptide (hBNP); Kineret® (anakinra); Leukine® (sargamostim, rhuGM-CSF); LymphoCide® (epratuzumab, anti-CD22 mAb); Benlysta™ (lymphostat B, belimumab, anti-BlyS mAb); Metalyse® (tenecteplase, t-PA analog); Mircera® (methoxy polyethylene glycol-epoetin beta); Mylotarg® (gemtuzumab ozogamicin); Raptiva® (efalizumab); Cimzia® (certolizumab pegol, CDP 870); Soliris™ (eculizumab); pexelizumab (anti-C5 complement); Numax®

(MEDI-524); Lucentis® (ranibizumab); Panorex® (17-1A, edrecolomab); Trabio® (lerdelimumab); TheraCim hR3 (nimotuzumab); Omnitarg (pertuzumab, 2C4); Osidem® (IDM-1); OvaRex® (B43.13); Nuvion® (visilizumab); cantuzumab mertansine (huC242- DM1); NeoRecormon® (epoetin beta); Neumega® (oprelvekin, human interleukin-11); Neulasta® (pegylated filgastrim, pegylated G-CSF, pegylated hu-Met-G-CSF); Neupogen® (filgrastim , G-CSF, hu-MetG-CSF); Orthoclone OKT3® (muromonab-CD3, anti- CD3 monoclonal antibody); Procrit® (epoetin alfa); Remicade® (infliximab, anti-TNFa monoclonal antibody); Reopro® (abciximab, anti-GP llb/llia receptor monoclonal antibody); Actemra® (anti-l L6 Receptor mAb); Avastin® (bevacizumab), HuMax- CD4 (zanolimumab); Rituxan® (rituximab, anti-CD20 mAb); Tarceva® (erlotinib); Roferon-A®-(interferon alfa-2a); Simulect® (basiliximab); Prexige® (lumiracoxib); Synagis® (palivizumab); 146B7-CHO (anti-IL15 antibody, see U.S. Patent No. 7,153,507); Tysabri® (natalizumab, anti-a4integrin mAb); Valortim® (MDX-1303, anti-B. anthracis protective antigen mAb); Abthrax™; Vectibix® (panitumumab); Xolair® (omalizumab); ETI211 (anti-MRSA mAb); IL-1 trap (the Fc portion of human lgG1 and the extracellular domains of both IL-1 receptor components (the Type I receptor and receptor accessory protein)); VEGF trap (Ig domains of VEGFR1 fused to lgG1 Fc); Zenapax® (daclizumab); Zenapax® (daclizumab, anti-IL-2Ra mAb); Zevalin® (ibritumomab tiuxetan); Zetia® (ezetimibe); Orencia® (atacicept, TACI-lg); anti-CD80 monoclonal antibody (galiximab); anti-CD23 mAb (lumiliximab); BR2-Fc (huBR3 / huFc fusion protein, soluble BAFF antagonist); ONTO 148 (golimumab, anti-TNFa mAb); HGS-ETR1 (mapatumumab; human anti-TRAIL Receptor-1 mAb); HuMax-CD20 (ocrelizumab, anti-CD20 human mAb); HuMax- EGFR (zalutumumab); M200 (volociximab, anti-a5pi integrin mAb); MDX-010 (ipilimumab, anti-CTLA-4 mAb and VEGFR-1 (IMC-18F1 ); anti-BR3 mAb; anti-C. difficile Toxin A and Toxin B C mAbs MDX-066 (CDA-1) and MDX-1388); anti-CD22 dsFv- PE38 conjugates (CAT-3888 and CAT-8015); anti-CD25 mAb (HuMax-TAC); anti-CD3 mAb (NI-0401); adecatumumab; anti- CD30 mAb (MDX-060); MDX-1333 (anti-IFNAR); anti-CD38 mAb (HuMax CD38); anti-CD40L mAb; anti-Cripto mAb; anti-CTGF Idiopathic Pulmonary Fibrosis Phase I Fibrogen (FG-3019); anti-CTLA4 mAb; anti-eotaxin 1 mAb (CAT-213); anti-FGF8 mAb; anti-ganglioside GD2 mAb; anti-ganglioside GM2 mAb; anti-GDF-8 human mAb (MYO-029); anti-GM-CSF Receptor mAb (CAM- 3001); anti-HepC mAb (HuMax HepC); anti-IFNa mAb (MEDI-545, MDX-1103); anti-IGF1 R mAb; anti-IGF-1 R mAb (HuMax- Inflam); anti-l L12 mAb (ABT-874); anti-IL12/IL23 mAb (CNTO 1275); anti-l L13 mAb (CAT-354); anti-IL2Ra mAb (HuMax-TAC); anti-IL5 Receptor mAb; anti-integrin receptors mAb (MDX-018, CNTO 95); anti-IP10 Ulcerative Colitis mAb (MDX-1100); anti-LLY antibody; BMS-66513; anti-Mannose Receptor/hCGp mAb (MDX-1307); anti-mesothelin dsFv-PE38 conjugate (CAT-5001); anti- PDImAb (MDX-1106 (ONO-4538)); anti-PDGFRa antibody (IMC-3G3); anti-TGFB mAb (GC-1008); anti-TRAIL Receptor-2 human mAb (HGS-ETR2); anti-TWEAK mAb; anti-VEGFR/Flt-1 mAb; anti-ZP3 mAb (HuMax-ZP3); NVS Antibody #1; and NVS Antibody #2.

[0089] Also included can be a sclerostin antibody, such as but not limited to romosozumab, blosozumab, or BPS 804 (Novartis). Further included can be therapeutics such as rilotumumab, bixalomer, trebananib, ganitumab, conatumumab, motesanib diphosphate, brodalumab, vidupiprant, panitumumab, denosumab, NPLATE, PROLIA, VECTIBIX or XGEVA. Additionally, included in the device can be a monoclonal antibody (IgG) that binds human Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9), e.g. U.S. Patent No. 8,030,547, U.S. Publication No. 2013/0064825, WC2008/057457, WC2008/057458, WC2008/057459, WC2008/063382, WC2008/133647, WC2009/100297, WC2009/100318, WO2011/037791, WO2011/053759, WO2011/053783, WC2008/125623, WO2011/072263, WC2009/055783, WO2012/0544438, WO2010/029513, WO2011/111007, WO2010/077854, WO2012/088313, WC2012/101251, WO2012/101252, WO2012/101253, WC2012/109530, and WC2001/031007.

[0090] Also included can be talimogene laherparepvec or another oncolytic HSV for the treatment of melanoma or other cancers. Examples of oncolytic HSV include, but are not limited to talimogene laherparepvec (U.S. Patent Nos. 7,223,593 and 7,537,924); OncoVEXGALV/CD (U.S. Pat. No. 7,981,669); OrienXOW (Lei et al. (2013), World J. Gastroenterol., 19:5138-5143); G207, 1716; NV1020; NV12023; NV1034 and NV1042 (Vargehes et al. (2002), Cancer Gene Then, 9(12):967-978). [0091] Also included are TIMPs. TIMPs are endogenous tissue inhibitors of metalloproteinases (TIMPs) and are important in many natural processes. TIMP-3 is expressed by various cells or and is present in the extracellular matrix; it inhibits all the major cartilage-degrading metalloproteases, and may play a role in role in many degradative diseases of connective tissue, including rheumatoid arthritis and osteoarthritis, as well as in cancer and cardiovascular conditions. The amino acid sequence of TIMP-3, and the nucleic acid sequence of a DNA that encodes TIMP-3, are disclosed in U.S. Patent No. 6,562,596, issued May 13, 2003, the disclosure of which is incorporated by reference herein. Description of TIMP mutations can be found in U.S. Publication No. 2014/0274874 and PCT Publication No. WO 2014/152012.

[0092] Also included are antagonistic antibodies for human calcitonin gene-related peptide (CGRP) receptor and bispecific antibody molecule that target the CGRP receptor and other headache targets. Further information concerning these molecules can be found in PCT Application No. WO 2010/075238.

[0093] Additionally, bispecific T cell engager (BiTE®) molecules, e.g. BLINCYTO® (blinatumomab), can be used in the methods disclosed herein. Alternatively, included can be an APJ large molecule agonist e.g., apelin or analogues thereof in the device. Information relating to such molecules can be found in PCT Publication No. WO 2014/099984.

[0094] In certain embodiments, the medicament comprises a therapeutically effective amount of an anti-thymic stromal lymphopoietin (TSLP) or TSLP receptor antibody. Examples of anti-TSLP antibodies that may be used in such embodiments include, but are not limited to, those described in U.S. Patent Nos. 7,982,016, and 8,232,372, and U.S. Publication No. 2009/0186022. Examples of anti-TSLP receptor antibodies include, but are not limited to, those described in U.S. Patent No. 8,101,182. In particularly preferred embodiments, the medicament comprises a therapeutically effective amount of the anti-TSLP antibody designated as A5 within U.S. Patent No. 7,982,016.

[0095] Although the foregoing systems and methods, and elements thereof, have been described in terms of exemplary embodiments, they are not limited thereto. The detailed description is to be construed as exemplary only and does not describe every possible embodiment of the invention because describing every possible embodiment would be impractical, if not impossible. Numerous alternative embodiments could be implemented, using either current technology or technology developed after the filing date of this patent that would still fall within the scope of the claims defining the invention.

[0096] It should be understood that the legal scope of the invention is defined by the words of the claims set forth at the end of this patent. The appended claims should be construed broadly to include other variants and embodiments of same, which may be made by those skilled in the art without departing from the scope and range of equivalents of the devices, systems, methods, and their elements.

Claims

What is claimed is:

1. A method for assessing transferability of a fill recipe for a drug container, the method comprising: collecting acceleration data of a needle of an off-line filler during a fill using an accelerometer coupled to the off-line filler, the fill according to a fill recipe; collecting acceleration data of a needle of an online filler during a fill using an accelerometer coupled to the online filler, the fill according to the fill recipe; calculating, via one or more processors, at least one of velocity, speed, or displacement data of the needle of the off-line filler during the fill and at least one of velocity, speed, or displacement data of the needle of the online filler during the fill; comparing at least one of the calculated velocity, speed, or displacement data of the needle of the off-line filler and at least one of the calculated velocity, speed, or displacement data of the needle of the online filler to identify any data discrepancy and/or alignment in one of the calculated velocity, speed, or displacement data; and adjusting at least one parameter of the fill recipe or another fill recipe for transferring to one or more of the online filler or a different online filler using any data discrepancy.

2. The method of claim 1 , wherein collecting acceleration data of a needle of an off-line filler during a fill using an accelerometer coupled to the off-line filler comprises collecting acceleration data of the needle of the off-line filler during the fill using the accelerometer coupled to a filling needle arm of the off-line filler configured to move with the needle.

3. The method of either one of claims 1 or 2, wherein collecting acceleration data of a needle of an online filler during a fill using an accelerometer coupled to the online filler comprises collecting the acceleration data of the needle of the online filler using the accelerometer coupled to a filling needle arm of the online filler configured to move with the needle.

4. The method of any one of claims 1-3, wherein calculating, via one or more processors, at least one of velocity, speed and displacement data of the needle of the off-line filler during the fill and at least one of velocity, speed and displacement data of the needle of the online filler during the fill comprises calculating velocity data of the needle of the off-line filler using the collected acceleration data of the needle of the off-line filler and calculating velocity data of the needle of the online filler using the collected acceleration data of the needle of the online filler.

5. The method of any one of claims 1-4, wherein calculating, via one or more processors, at least one of velocity, speed and displacement data of the needle of the off-line filler during the fill and at least one of velocity, speed and displacement data of the needle of the online filler during the fill comprises calculating, via one or more processors, velocity data of the needle of the off-line filler during the fill and velocity data of the needle of the online filler during the fill and detrending the collected acceleration data of each of the off-line filler and the online filler to remove drift by selecting an interval of time of the collected acceleration data of each of the off-line filler and the online filler and applying a linear fit to the collected acceleration data of each of the off-line filler and the online filler at the interval of time.

6. The method of any one of claim 1-5, wherein calculating, via one or more processors, at least one of velocity, speed, or displacement data of the needle of the off-line filler during the fill and at least one of velocity, speed, or displacement data of the needle of the online filler during the fill comprises calculating, via the one or more processors, displacement data of the needle of at least one of the off-line filler or the online filler during the fill by integrating the calculated velocity data of at least one of the off-line filler or the online filler, respectively.

7. The method of any one of claims 1-6, wherein comparing at least one of the calculated velocity, speed, or displacement data of the needle of the off-line filler and at least one of the calculated velocity, speed, or displacement data of the needle of the online filler to identify any data discrepancy and/or alignment in one of the calculated velocity, speed, or displacement data comprises generating, via one or more processors, a graphical representation of at least one of the calculated velocity, speed, or displacement data of the needle of the off-line filler and at least one of the calculated velocity, speed, or displacement data of the needle of the online filler, including generating the graphical representation on a graphical user interface of a computing device coupled to at least one of the off-line filler and the online filler.

8. The method of any one of claims 1-7, wherein after adjusting at least one parameter of the fill recipe for transferring to one or more of the online filler or a different online filler using any data discrepancy, the method further comprises comparing at least one of the calculated velocity, speed, or displacement data of the needle of the off-line filler during the fill according to the fill recipe with at least one of the calculated velocity, speed, or displacement data of the online filler during the fill according to an adjusted fill recipe using at least one overlay generated in a graphical representation on a graphical user interface and confirming the transferability of the adjusted fill recipe for the online filler or the different online filler.

9. The method of any one of claims 1-8, wherein adjusting at least one parameter of the fill recipe for transferring to one or more of the online filler or a different online filler using any data discrepancy comprises changing one or more needle movement parameters or pump parameters of the online filler based on a data discrepancy identified in overlaying the at least one of the calculated velocity, speed, or displacement data of the off-line filler and at least one of the calculated velocity, speed, or displacement data of the online filler, the needle movement parameters including one or more of maximum main drive speed, needle setting dimension, basic needle position, container end position, and filling level end position, and the pump parameters including one or more of pump dosing speed and pump dosing stop ramp.

10. The method of any one of claim 1-9, wherein collecting acceleration data of a needle of an off-line filler during a fill using an accelerometer coupled to the off-line filler and collecting acceleration data of a needle of an online filler during a fill using an accelerometer coupled to the online filler further comprises collecting the acceleration data of the needle of one or more of the off-line filler and the online filler using the accelerometer and a high-speed camera.

11. A system for assessing transferability of a fill recipe for a drug container, the system comprising: an off-line filler having a needle; an accelerometer coupled to a portion of the off-line filler and configured to collect acceleration data of the needle of the off-line filler during a fill; a computing device coupled to the accelerometer and having at least one processor and a memory communicatively coupled to the processor, the memory including computer-readable instructions that, when executed, cause the at least one processor to: calculate at least one of velocity, speed, or displacement data of the needle of the off-line filler using the acceleration data collected by the accelerometer during the fill; and compare the at least one of the calculated velocity, speed, or displacement data of the needle of the off-line filler to at least one of a threshold velocity, speed, or displacement data, respectively, or at least one of a calculated velocity, speed, or displacement data, respectively, of a needle of an online filler during a fill to identify any data discrepancy for adjusting the fill recipe to be transferred to the online filler.

12. The system of claim 11, wherein the off-line filler further comprises a needle filling arm and the accelerator is operatively coupled to the needle filling arm and moveable with the needle filling arm.

13. The system of either one of claims 11 or 12, the system further comprising a high-speed camera configured to be used with the accelerometer in collecting acceleration data of the needle of the off-line filler.

14. The system of any one of claims 11-13, further comprising an online filler and an accelerator coupled to the online filler, the accelerator coupled to the online filler configured to collect acceleration data relative to a needle of the online filler during a fill according to the same recipe as the fill of the off-line filler, and the computing device coupled to the accelerometer of the online filler and the memory including computer-readable instructions that, when executed, further cause the at least one processor to: calculate at least one of velocity, speed, or displacement data of the needle of the online filler using the acceleration data collected by the accelerometer coupled to the online filler during the fill; and generate a graphical representation of at least one of the calculated velocity, speed, or displacement data of the needle of the off-line filler and at least one of the calculated velocity, speed, or displacement data of the needle of the online filler, wherein the at least one of the calculated velocity, speed, or displacement data of the needle of the off-line filler is overlaid with the at least one of the calculated velocity, speed, or displacement data, respectively, of the online filler to identify any data discrepancy for use with determining a fill recipe for the online filler.

15. The system of any one of claims 11-14, wherein the computer-readable instructions that, when executed, cause the at least one processor to calculate at least one of the velocity, speed, or displacement data of the needle of the off-line filler during the fill further comprises instructions that cause the at least one processor to: calculate the velocity data of the needle by detrending the collected acceleration data of the off-line filler to remove drift by selecting an interval of time of the collected acceleration data and applying a linear fit to the collected acceleration data at the interval of time and then along an entire period of time of the collected acceleration data according to the interval of time.

16. The system of any one of clams 11-15, further comprising that the computer readable instructions that, when executed, cause the at least one processor to adjust at least one parameter of the fill recipe for transferring to one or more of the online filler or another online filler using any data discrepancy and confirm the transferability of an adjusted fill recipe for the online filler or another online filler.

17. The system of any one of claims 11-16, wherein the memory includes the computer-readable instructions that, when executed, further cause the at least one processor to generate a graphical representation of at least one of the calculated velocity, speed, or displacement data of the needle of the off-line filler and at least one of the threshold velocity, speed, or displacement data or at least one of the calculated velocity, speed, or displacement data of the needle of the online filler for use with determining a fill recipe for the online filler, wherein at least one of the velocity, speed, or displacement data of the needle of the off-line filler is overlaid with at least one of the threshold velocity, speed, or displacement data, respectively, or at least one of the calculated velocity, speed, or displacement data, respectively, of the online filler, and the computing device further comprises a graphical user interface on which the graphical representation is generated.

18. A tangible, computer-readable medium storing instructions that when executed by one or more processors of a computing system cause the computer system to: calculate at least one of velocity, speed, or displacement data of a needle of the off-line filler using the acceleration data collected by an accelerometer coupled to the off-line filler during the fill; and generate a graphical representation of at least one of the calculated velocity, speed, or displacement data of the needle of the off-line filler relative to calculated velocity, speed, or acceleration data of a needle of an online filler for use with determining a fill recipe for the online filler, wherein at least one of the calculated velocity, speed, or displacement data of the needle of the off-line filler is overlaid with at least one of the calculated velocity, speed, or acceleration data, respectively, of the online filler to identify any data discrepancy.

19. The computer-readable medium of claim 18, which further causes the computer system to adjust at least one parameter of the fill recipe for transferring to one or more of the online filler or another online filler using any identified data discrepancy and confirm the transferability of an adjusted fill recipe for the online filler or another online filler.

20. The computer-readable medium of either one of claims 18 or 19, which further causes the computer system to calculate the velocity data of the needle of the off-line filler during the fill and at least one of: detrend the collected acceleration data of the off-line filler to remove drift by selecting an interval of time of the collected acceleration data and applying a linear fit to the collected acceleration data at the interval of time and then along an entire period of time of the collected acceleration data according to the interval of time; or calculate displacement of the needle of the off-line filler by integrating the calculated velocity data.