JP2021519752A - 単量体モノクローナル抗体を精製する方法 - Google Patents

単量体モノクローナル抗体を精製する方法 Download PDF

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Publication number
JP2021519752A
JP2021519752A JP2020552186A JP2020552186A JP2021519752A JP 2021519752 A JP2021519752 A JP 2021519752A JP 2020552186 A JP2020552186 A JP 2020552186A JP 2020552186 A JP2020552186 A JP 2020552186A JP 2021519752 A JP2021519752 A JP 2021519752A
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Japan
Prior art keywords
monoclonal antibody
cell culture
protein
cex
monomeric
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JP2020552186A
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English (en)
Japanese (ja)
Inventor
タン・ジジュン
ヴィヴェク・エハンパラナタン
ソン・ユアンリ
アンジェラ・ティ・レワンドウスキー
ジェンジアン・リ
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Bristol Myers Squibb Co
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Bristol Myers Squibb Co
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Application filed by Bristol Myers Squibb Co filed Critical Bristol Myers Squibb Co
Publication of JP2021519752A publication Critical patent/JP2021519752A/ja
Priority to JP2024028517A priority Critical patent/JP2024059888A/ja
Pending legal-status Critical Current

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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/06—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies from serum
    • C07K16/065—Purification, fragmentation
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D15/00—Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08—Selective adsorption, e.g. chromatography
    • B01D15/26—Selective adsorption, e.g. chromatography characterised by the separation mechanism
    • B01D15/36—Selective adsorption, e.g. chromatography characterised by the separation mechanism involving ionic interaction, e.g. ion-exchange, ion-pair, ion-suppression or ion-exclusion
    • B01D15/361—Ion-exchange
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D15/00—Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08—Selective adsorption, e.g. chromatography
    • B01D15/26—Selective adsorption, e.g. chromatography characterised by the separation mechanism
    • B01D15/38—Selective adsorption, e.g. chromatography characterised by the separation mechanism involving specific interaction not covered by one or more of groups B01D15/265 and B01D15/30 - B01D15/36, e.g. affinity, ligand exchange or chiral chromatography
    • B01D15/3804—Affinity chromatography
    • 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
    • C07K1/16—Extraction; Separation; Purification by chromatography
    • C07K1/165—Extraction; Separation; Purification by chromatography mixed-mode chromatography
    • 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
    • C07K1/16—Extraction; Separation; Purification by chromatography
    • C07K1/18—Ion-exchange chromatography
    • 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
    • C07K1/16—Extraction; Separation; Purification by chromatography
    • C07K1/22—Affinity chromatography or related techniques based upon selective absorption processes
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N5/00—Undifferentiated human, animal or plant cells, e.g. cell lines; Tissues; Cultivation or maintenance thereof; Culture media therefor
    • C12N5/06—Animal cells or tissues; Human cells or tissues
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565—Complementarity determining region [CDR]
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2500/00—Specific components of cell culture medium
    • C12N2500/30—Organic components
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2500/00—Specific components of cell culture medium
    • C12N2500/60—Buffer, e.g. pH regulation, osmotic pressure

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  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Genetics & Genomics (AREA)
  • General Health & Medical Sciences (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Medicinal Chemistry (AREA)
  • Analytical Chemistry (AREA)
  • Immunology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Biotechnology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Engineering & Computer Science (AREA)
  • Cell Biology (AREA)
  • Microbiology (AREA)
  • Peptides Or Proteins (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
JP2020552186A 2018-03-29 2019-03-28 単量体モノクローナル抗体を精製する方法 Pending JP2021519752A (ja)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2024028517A JP2024059888A (ja) 2018-03-29 2024-02-28 単量体モノクローナル抗体を精製する方法

Applications Claiming Priority (3)

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US201862649976P 2018-03-29 2018-03-29
US62/649,976 2018-03-29
PCT/US2019/024565 WO2019191416A1 (en) 2018-03-29 2019-03-28 Methods of purifying monomeric monoclonal antibodies

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JP2024028517A Division JP2024059888A (ja) 2018-03-29 2024-02-28 単量体モノクローナル抗体を精製する方法

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JP2021519752A true JP2021519752A (ja) 2021-08-12

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JP2024028517A Pending JP2024059888A (ja) 2018-03-29 2024-02-28 単量体モノクローナル抗体を精製する方法

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US (1) US20210009632A1 (enExample)
EP (1) EP3774882A1 (enExample)
JP (2) JP2021519752A (enExample)
KR (1) KR20200136464A (enExample)
CN (1) CN112313248A (enExample)
WO (1) WO2019191416A1 (enExample)

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TW201628649A (zh) 2014-10-09 2016-08-16 再生元醫藥公司 減少醫藥調配物中微可見顆粒之方法
KR20230041834A (ko) 2016-08-16 2023-03-24 리제너론 파아마슈티컬스, 인크. 혼합물로부터 개별 항체들을 정량하는 방법
CN119492842A (zh) 2016-10-25 2025-02-21 里珍纳龙药品有限公司 用于色谱数据分析的方法和系统
CN118416215A (zh) 2017-09-19 2024-08-02 里珍纳龙药品有限公司 减少粒子形成的方法以及由其形成的组合物
TWI853823B (zh) 2018-07-02 2024-09-01 美商里珍納龍藥品有限公司 自混合物製備多肽之系統及方法
EP3934620A1 (en) 2019-03-05 2022-01-12 Regeneron Pharmaceuticals, Inc. Human serum albumin in formulations
CN114981286B (zh) 2019-05-03 2026-02-13 豪夫迈·罗氏有限公司 降低从纯化平台获得的组合物中酶水解活性速率的方法
EP4090666A1 (en) 2020-01-15 2022-11-23 F. Hoffmann-La Roche AG Methods to decrease impurities from recombinant protein manufacturing processes
US20240262928A1 (en) * 2020-03-27 2024-08-08 Haemalogix Pty Ltd Composition and Method
AU2021371309A1 (en) * 2020-10-30 2023-05-18 Genentech, Inc. Purification platforms for obtaining pharmaceutical compositions having a reduced hydrolytic enzyme activity rate

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2011502161A (ja) * 2007-10-30 2011-01-20 ジェネンテック， インコーポレイテッド 陽イオン交換クロマトグラフィーによる抗体の精製
WO2011037983A1 (en) * 2009-09-23 2011-03-31 Medarex, Inc. Cation exchange chromatography
WO2017095875A1 (en) * 2015-11-30 2017-06-08 Bristol-Myers Squibb Company Anti human ip-10 antibodies and their uses

Family Cites Families (36)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4816567A (en) 1983-04-08 1989-03-28 Genentech, Inc. Recombinant immunoglobin preparations
US5225539A (en) 1986-03-27 1993-07-06 Medical Research Council Recombinant altered antibodies and methods of making altered antibodies
US5476996A (en) 1988-06-14 1995-12-19 Lidak Pharmaceuticals Human immune system in non-human animal
US5223409A (en) 1988-09-02 1993-06-29 Protein Engineering Corp. Directed evolution of novel binding proteins
GB8823869D0 (en) 1988-10-12 1988-11-16 Medical Res Council Production of antibodies
US5530101A (en) 1988-12-28 1996-06-25 Protein Design Labs, Inc. Humanized immunoglobulins
US6673986B1 (en) 1990-01-12 2004-01-06 Abgenix, Inc. Generation of xenogeneic antibodies
ES2284161T3 (es) 1990-01-12 2007-11-01 Amgen Fremont Inc. Generacion de anticuerpos xenogenicos.
US6075181A (en) 1990-01-12 2000-06-13 Abgenix, Inc. Human antibodies derived from immunized xenomice
US6150584A (en) 1990-01-12 2000-11-21 Abgenix, Inc. Human antibodies derived from immunized xenomice
US5427908A (en) 1990-05-01 1995-06-27 Affymax Technologies N.V. Recombinant library screening methods
US6172197B1 (en) 1991-07-10 2001-01-09 Medical Research Council Methods for producing members of specific binding pairs
GB9015198D0 (en) 1990-07-10 1990-08-29 Brien Caroline J O Binding substance
US5661016A (en) 1990-08-29 1997-08-26 Genpharm International Inc. Transgenic non-human animals capable of producing heterologous antibodies of various isotypes
US5874299A (en) 1990-08-29 1999-02-23 Genpharm International, Inc. Transgenic non-human animals capable of producing heterologous antibodies
US5814318A (en) 1990-08-29 1998-09-29 Genpharm International Inc. Transgenic non-human animals for producing heterologous antibodies
US6255458B1 (en) 1990-08-29 2001-07-03 Genpharm International High affinity human antibodies and human antibodies against digoxin
US5789650A (en) 1990-08-29 1998-08-04 Genpharm International, Inc. Transgenic non-human animals for producing heterologous antibodies
US5877397A (en) 1990-08-29 1999-03-02 Genpharm International Inc. Transgenic non-human animals capable of producing heterologous antibodies of various isotypes
US5625126A (en) 1990-08-29 1997-04-29 Genpharm International, Inc. Transgenic non-human animals for producing heterologous antibodies
AU8507191A (en) 1990-08-29 1992-03-30 Genpharm International, Inc. Transgenic non-human animals capable of producing heterologous antibodies
US5545806A (en) 1990-08-29 1996-08-13 Genpharm International, Inc. Ransgenic non-human animals for producing heterologous antibodies
US6300129B1 (en) 1990-08-29 2001-10-09 Genpharm International Transgenic non-human animals for producing heterologous antibodies
US5770429A (en) 1990-08-29 1998-06-23 Genpharm International, Inc. Transgenic non-human animals capable of producing heterologous antibodies
US5633425A (en) 1990-08-29 1997-05-27 Genpharm International, Inc. Transgenic non-human animals capable of producing heterologous antibodies
PT1696031E (pt) 1991-12-02 2010-06-25 Medical Res Council Produção de auto-anticorpos a partir de reportórios de segmentos de anticorpo e exibidos em fagos
AU3328493A (en) 1991-12-17 1993-07-19 Genpharm International, Inc. Transgenic non-human animals capable of producing heterologous antibodies
DE69303494T2 (de) 1992-11-13 1997-01-16 Idec Pharma Corp Therapeutische verwendung von chimerischen und markierten antikörper gegen menschlichen b lymphozyt beschränkter differenzierung antigen für die behandlung von b-zell-lymphoma
AU6819494A (en) 1993-04-26 1994-11-21 Genpharm International, Inc. Transgenic non-human animals capable of producing heterologous antibodies
US5534615A (en) 1994-04-25 1996-07-09 Genentech, Inc. Cardiac hypertrophy factor and uses therefor
CN102766210B (zh) 1999-08-24 2015-07-08 E.R.施贵宝&圣斯有限责任公司 人ctla-4抗体及其应用
IL155977A0 (en) 2000-11-30 2003-12-23 Medarex Inc Transgenic transchromosomal rodents for making human antibodies
WO2005060457A2 (en) * 2003-12-04 2005-07-07 Pdl Biopharma, Inc. Treatment of inflammatory bowel diseases with anti-ip-10 antibodies
US20130178608A1 (en) * 2009-12-29 2013-07-11 Samir Kulkarni Protein purification by ion exchange
CN106414495A (zh) * 2014-02-07 2017-02-15 诺和诺德股份有限公司 抗体处理方法
JP2019530646A (ja) * 2016-08-12 2019-10-24 ブリストル−マイヤーズ スクイブ カンパニーＢｒｉｓｔｏｌ−Ｍｙｅｒｓ Ｓｑｕｉｂｂ Ｃｏｍｐａｎｙ タンパク質精製法

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2011502161A (ja) * 2007-10-30 2011-01-20 ジェネンテック， インコーポレイテッド 陽イオン交換クロマトグラフィーによる抗体の精製
WO2011037983A1 (en) * 2009-09-23 2011-03-31 Medarex, Inc. Cation exchange chromatography
WO2017095875A1 (en) * 2015-11-30 2017-06-08 Bristol-Myers Squibb Company Anti human ip-10 antibodies and their uses

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
MABS, vol. 5, no. 1, JPN6023008338, 2013, pages 102 - 113, ISSN: 0005006583 *

Also Published As

Publication number Publication date
KR20200136464A (ko) 2020-12-07
JP2024059888A (ja) 2024-05-01
CN112313248A (zh) 2021-02-02
WO2019191416A1 (en) 2019-10-03
US20210009632A1 (en) 2021-01-14
EP3774882A1 (en) 2021-02-17

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