KR20200136464A - 단량체성 모노클로날 항체를 정제하는 방법 - Google Patents

단량체성 모노클로날 항체를 정제하는 방법 Download PDF

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Publication number
KR20200136464A
KR20200136464A KR1020207030734A KR20207030734A KR20200136464A KR 20200136464 A KR20200136464 A KR 20200136464A KR 1020207030734 A KR1020207030734 A KR 1020207030734A KR 20207030734 A KR20207030734 A KR 20207030734A KR 20200136464 A KR20200136464 A KR 20200136464A
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KR
South Korea
Prior art keywords
monoclonal antibody
cell culture
species
ser
protein
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Ceased
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KR1020207030734A
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English (en)
Korean (ko)
Inventor
지준 탄
비베크 에함파라나탄
유안리 송
안젤라 티. 레반도프스키
젱지안 리
Original Assignee
브리스톨-마이어스 스큅 컴퍼니
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Publication of KR20200136464A publication Critical patent/KR20200136464A/ko
Ceased 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)
KR1020207030734A 2018-03-29 2019-03-28 단량체성 모노클로날 항체를 정제하는 방법 Ceased KR20200136464A (ko)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
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

Publications (1)

Publication Number Publication Date
KR20200136464A true KR20200136464A (ko) 2020-12-07

Family

ID=66286977

Family Applications (1)

Application Number Title Priority Date Filing Date
KR1020207030734A Ceased KR20200136464A (ko) 2018-03-29 2019-03-28 단량체성 모노클로날 항체를 정제하는 방법

Country Status (6)

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

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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

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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
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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

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JP2021519752A (ja) 2021-08-12
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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