CL2021001958A1 - 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
CL2021001958A1
CL2021001958A1 CL2021001958A CL2021001958A CL2021001958A1 CL 2021001958 A1 CL2021001958 A1 CL 2021001958A1 CL 2021001958 A CL2021001958 A CL 2021001958A CL 2021001958 A CL2021001958 A CL 2021001958A CL 2021001958 A1 CL2021001958 A1 CL 2021001958A1
Authority
CL
Chile
Prior art keywords
active ingredient
finished product
manufacturing process
integration
manufacture
Prior art date
Application number
CL2021001958A
Other languages
English (en)
Inventor
Balakumar Thangaraj
Malhar R Ambhaikar
Vincent Chai
Philip Clark
Subramanian GUHAN
Sai Chakradhar Padala
Nitin Rathore
Zane Saremi
Ashish Sharma
Kenneth Shoemaker
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 CL2021001958A1 publication Critical patent/CL2021001958A1/es

Links

Classifications

    • 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
    • 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
    • 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
    • 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
    • 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
    • C07K1/36—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
    • C07K16/30—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)
  • Immunology (AREA)
  • General Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Water Supply & Treatment (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • General Chemical & Material Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Cell Biology (AREA)
  • Dermatology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Inorganic Chemistry (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Plant Substances (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)

Abstract

Un procedimiento de fabricación de productos biológicos que conecta los procedimientos de principio activo y producto terminado en un procedimiento continuo, integrado.
CL2021001958A 2019-01-28 2021-07-26 Procedimiento de fabricación continuo para la fabricación de productos biológicos mediante integración de procedimientos de principio activo y producto terminado. CL2021001958A1 (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
CL2021001958A1 true CL2021001958A1 (es) 2022-01-28

Family

ID=69740575

Family Applications (2)

Application Number Title Priority Date Filing Date
CL2021001958A CL2021001958A1 (es) 2019-01-28 2021-07-26 Procedimiento de fabricación continuo para la fabricación de productos biológicos mediante integración de procedimientos de principio activo y producto terminado.
CL2023001293A CL2023001293A1 (es) 2019-01-28 2023-05-04 Procedimiento de fabricación para productos biológicos mediante integración de procedimientos principio activo - producto terminado

Family Applications After (1)

Application Number Title Priority Date Filing Date
CL2023001293A CL2023001293A1 (es) 2019-01-28 2023-05-04 Procedimiento de fabricación para productos biológicos mediante integración de procedimientos principio activo - producto terminado

Country Status (16)

Country Link
US (1) US20220119526A1 (es)
EP (1) EP3917494A1 (es)
JP (1) JP2022523025A (es)
KR (1) KR20210120032A (es)
CN (1) CN113382716A (es)
AR (1) AR117896A1 (es)
AU (1) AU2020216108A1 (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) TW202043253A (es)
WO (1) WO2020159838A1 (es)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2020381536A1 (en) * 2019-11-13 2022-04-21 Amgen Inc. Method for reduced aggregate formation in downstream processing of bispecific antigen-binding molecules
EP4090666A1 (en) 2020-01-15 2022-11-23 F. Hoffmann-La Roche AG Methods to decrease impurities from recombinant protein manufacturing processes
WO2021220251A1 (en) * 2020-05-01 2021-11-04 Kashiv Biosciences, Llc An improved process of purification of protein
TW202424198A (zh) 2022-09-06 2024-06-16 美商安進公司 精簡灌注細胞培養方法
WO2024059235A2 (en) 2022-09-16 2024-03-21 Amgen Inc. A method for harvesting products from perfusion cultures
WO2024191971A1 (en) 2023-03-13 2024-09-19 Amgen Inc. Virus filtration operations employing an oversized virus prefilter
US20240309044A1 (en) 2023-03-14 2024-09-19 Amgen Inc. Anion exchange chromatography processes using a primary amine ligand

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US6319494B1 (en) 1990-12-14 2001-11-20 Cell Genesys, Inc. Chimeric chains for receptor-associated signal transduction pathways
IL104570A0 (en) 1992-03-18 1993-05-13 Yeda Res & Dev Chimeric genes and cells transformed therewith
NZ507381A (en) 1998-04-21 2003-12-19 Micromet Ag CD19xCD3 specific polypeptides and uses thereof
CA2542239C (en) 2003-10-16 2014-12-30 Micromet Ag Multispecific deimmunized cd3-binders
US20060051347A1 (en) * 2004-09-09 2006-03-09 Winter Charles M Process for concentration of antibodies and therapeutic products thereof
WO2008119567A2 (en) 2007-04-03 2008-10-09 Micromet Ag Cross-species-specific cd3-epsilon binding domain
BR112012002574A2 (pt) * 2009-08-06 2020-11-03 Genentech, Inc. método para aprimorar a remoção de vírus na purificação de proteínas
LT3037104T (lt) * 2009-10-20 2020-09-10 Abbvie Inc. Anti-il-13 antikūnų izoliavimas ir gryninimas, naudojant afininę baltymo a chromatografiją
CA2831572C (en) * 2011-05-02 2019-11-26 Immunomedics, Inc. Ultrafiltration concentration of allotype selected antibodies for small-volume administration
MX353382B (es) 2012-03-01 2018-01-10 Amgen Res Munich Gmbh Moleculas de union polipeptido de larga duracion.
WO2014072277A1 (de) * 2012-11-06 2014-05-15 Bayer Pharma Aktiengesellschaft Formulierung für bispecific t-cell-engangers (bites)
LT2970449T (lt) 2013-03-15 2019-11-25 Amgen Res Munich Gmbh Viengrandės surišančios molekulės, apimančios n galo abp
US20140308285A1 (en) 2013-03-15 2014-10-16 Amgen Inc. Heterodimeric bispecific antibodies
US20140302037A1 (en) 2013-03-15 2014-10-09 Amgen Inc. BISPECIFIC-Fc MOLECULES
AU2014236769B2 (en) 2013-03-15 2018-09-27 Amgen Inc. Heterodimeric bispecific antibodies
WO2015048272A1 (en) 2013-09-25 2015-04-02 Amgen Inc. V-c-fc-v-c antibody
WO2016005903A2 (en) * 2014-07-08 2016-01-14 Theramyt Novobiologics Private Limited A process for obtaining exendin-4
EP3352790A1 (en) * 2015-09-22 2018-08-01 Pfizer Inc Method of preparing a therapeutic protein formulation and antibody formulation produced by such a method
EP3368176A2 (en) * 2015-10-26 2018-09-05 Lonza Limited A manufacturing facility for the production of biopharmaceuticals
EA039859B1 (ru) 2016-02-03 2022-03-21 Эмджен Рисерч (Мюник) Гмбх Биспецифические конструкты антител, связывающие egfrviii и cd3
CN109563124A (zh) * 2016-06-17 2019-04-02 豪夫迈·罗氏有限公司 多特异性抗体的纯化
WO2018152165A1 (en) * 2017-02-16 2018-08-23 Reform Biologics, Llc Excipient compounds for protein processing
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Also Published As

Publication number Publication date
CA3127258A1 (en) 2020-08-06
AR117896A1 (es) 2021-09-01
TW202043253A (zh) 2020-12-01
EP3917494A1 (en) 2021-12-08
BR112021014634A2 (pt) 2021-10-26
JP2022523025A (ja) 2022-04-21
KR20210120032A (ko) 2021-10-06
CN113382716A (zh) 2021-09-10
CL2023001293A1 (es) 2023-10-06
AU2020216108A1 (en) 2021-08-12
US20220119526A1 (en) 2022-04-21
IL284782A (en) 2021-08-31
EA202192108A1 (ru) 2021-10-21
SG11202107714VA (en) 2021-08-30
MX2021008985A (es) 2021-09-08
WO2020159838A1 (en) 2020-08-06

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