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AR117896A1 - Procedimiento de fabricación continuo para la fabricación de productos biológicos mediante integración de procedimientos de principio activo y producto terminado - Google Patents

Procedimiento de fabricación continuo para la fabricación de productos biológicos mediante integración de procedimientos de principio activo y producto terminado

Info

Publication number
AR117896A1
AR117896A1 ARP200100205A ARP200100205A AR117896A1 AR 117896 A1 AR117896 A1 AR 117896A1 AR P200100205 A ARP200100205 A AR P200100205A AR P200100205 A ARP200100205 A AR P200100205A AR 117896 A1 AR117896 A1 AR 117896A1
Authority
AR
Argentina
Prior art keywords
finished product
integration
manufacture
active principle
manufacturing procedure
Prior art date
Application number
ARP200100205A
Other languages
English (en)
Inventor
Balakumar Thangaraj
Ashish Sharma
Kenneth Shoemaker
Zane J Saremi
Nitin Rathore
Sai Chakradhar Padala
Subramanian GUHAN
Philip Clark
Vincent C Chai
Malhar R Ambhaikar
John E Thorup
Benjamin J Tillotson
Hann-Chung Wong
Original Assignee
Amgen Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Amgen Inc filed Critical Amgen Inc
Publication of AR117896A1 publication Critical patent/AR117896A1/es

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D61/00—Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor
    • B01D61/14—Ultrafiltration; Microfiltration
    • B01D61/145—Ultrafiltration
    • B01D61/146—Ultrafiltration comprising multiple ultrafiltration steps
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D63/00—Apparatus in general for separation processes using semi-permeable membranes
    • B01D63/02—Hollow fibre modules
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D71/00—Semi-permeable membranes for separation processes or apparatus characterised by the material; Manufacturing processes specially adapted therefor
    • B01D71/06—Organic material
    • B01D71/30—Polyalkenyl halides
    • B01D71/32—Polyalkenyl halides containing fluorine atoms
    • B01D71/34—Polyvinylidene fluoride
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14—Extraction; Separation; Purification
    • C07K1/34—Extraction; Separation; Purification by filtration, ultrafiltration or reverse osmosis
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14—Extraction; Separation; Purification
    • C07K1/36—Extraction; Separation; Purification by a combination of two or more processes of different types
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • C07K16/2809—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily against the T-cell receptor (TcR)-CD3 complex
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/30—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D2315/00—Details relating to the membrane module operation
    • B01D2315/16—Diafiltration
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D2317/00—Membrane module arrangements within a plant or an apparatus
    • B01D2317/02—Elements in series
    • B01D2317/022—Reject series
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/31—Immunoglobulins specific features characterized by aspects of specificity or valency multispecific

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Water Supply & Treatment (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Analytical Chemistry (AREA)
  • Cell Biology (AREA)
  • Dermatology (AREA)
  • Inorganic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicines Containing Plant Substances (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)

Abstract

Un procedimiento de fabricación de productos biológicos que conecta los procedimientos de principio activo y producto terminado en un procedimiento continuo, integrado.
ARP200100205A 2019-01-28 2020-01-27 Procedimiento de fabricación continuo para la fabricación de productos biológicos mediante integración de procedimientos de principio activo y producto terminado AR117896A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US201962797445P 2019-01-28 2019-01-28

Publications (1)

Publication Number Publication Date
AR117896A1 true AR117896A1 (es) 2021-09-01

Family

ID=69740575

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP200100205A AR117896A1 (es) 2019-01-28 2020-01-27 Procedimiento de fabricación continuo para la fabricación de productos biológicos mediante integración de procedimientos de principio activo y producto terminado

Country Status (16)

Country Link
US (1) US20220119526A1 (es)
EP (1) EP3917494A1 (es)
JP (2) JP7617004B2 (es)
KR (1) KR20210120032A (es)
CN (2) CN113382716A (es)
AR (1) AR117896A1 (es)
AU (2) AU2020216108B2 (es)
BR (1) BR112021014634A2 (es)
CA (1) CA3127258A1 (es)
CL (2) CL2021001958A1 (es)
EA (1) EA202192108A1 (es)
IL (1) IL284782A (es)
MX (1) MX2021008985A (es)
SG (1) SG11202107714VA (es)
TW (1) TWI871300B (es)
WO (1) WO2020159838A1 (es)

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MX2021012078A (es) * 2019-04-03 2022-01-04 Genzyme Corp Produccion continua de proteinas recombinantes.
AU2020268896B2 (en) 2019-05-03 2024-11-28 F. Hoffmann-La Roche Ag Methods of reducing the enzymatic hydrolysis activity rate in a composition obtained from a purification platform
WO2021097344A1 (en) * 2019-11-13 2021-05-20 Amgen Inc. Method for reduced aggregate formation in downstream processing of bispecific antigen-binding molecules
TW202140511A (zh) * 2020-01-15 2021-11-01 瑞士商赫孚孟拉羅股份公司 減少來自重組蛋白生產過程中的雜質之方法
US20230167153A1 (en) * 2020-05-01 2023-06-01 Kashiv Biosciences, Llc An improved process of purification of protein
AU2023338683A1 (en) 2022-09-06 2025-03-13 Amgen Inc. Lean perfusion cell culture methods
EP4587548A2 (en) 2022-09-16 2025-07-23 Amgen Inc. A method for harvesting products from perfusion cultures
EP4680380A1 (en) 2023-03-13 2026-01-21 Amgen Inc. Virus filtration operations employing an oversized virus prefilter
CN120958009A (zh) 2023-03-14 2025-11-14 安进公司 使用伯胺配体的阴离子交换色谱工艺
AU2024313665A1 (en) 2023-06-20 2025-12-11 Amgen Inc. Methods for chromatography and chromatography medium reuse
WO2025029614A1 (en) 2023-07-28 2025-02-06 Amgen Inc. A method for equilibrating a chromatography medium
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KR102790037B1 (ko) 2024-04-11 2025-04-04 주식회사 보부상바이오팜 인공지능 모델 기반 타정성 최적화를 위한 건강기능식품 원료 배합 및 환경 제어 최적화 방법, 장치 및 시스템

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DE69909459T2 (de) 1998-04-21 2004-05-27 Micromet Ag Cd19xcd3 spezifische polypeptide und deren verwendung
US8076459B2 (en) 2003-10-16 2011-12-13 Micromet Ag Multispecfic deimmunized CD3-binders
US20060051347A1 (en) * 2004-09-09 2006-03-09 Winter Charles M Process for concentration of antibodies and therapeutic products thereof
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Also Published As

Publication number Publication date
AU2020216108B2 (en) 2025-07-03
AU2020216108A1 (en) 2021-08-12
TW202043253A (zh) 2020-12-01
JP7617004B2 (ja) 2025-01-17
JP2022523025A (ja) 2022-04-21
JP2025028874A (ja) 2025-03-05
SG11202107714VA (en) 2021-08-30
CN118994410A (zh) 2024-11-22
CA3127258A1 (en) 2020-08-06
CN113382716A (zh) 2021-09-10
CL2021001958A1 (es) 2022-01-28
MX2021008985A (es) 2021-09-08
EA202192108A1 (ru) 2021-10-21
TWI871300B (zh) 2025-02-01
IL284782A (en) 2021-08-31
KR20210120032A (ko) 2021-10-06
WO2020159838A1 (en) 2020-08-06
AU2025238136A1 (en) 2025-10-23
US20220119526A1 (en) 2022-04-21
CL2023001293A1 (es) 2023-10-06
EP3917494A1 (en) 2021-12-08
BR112021014634A2 (pt) 2021-10-26

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