CN114929725A - 阿达木单抗纯化方法及其稳定组合物 - Google Patents

阿达木单抗纯化方法及其稳定组合物 Download PDF

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Publication number
CN114929725A
CN114929725A CN202180008565.2A CN202180008565A CN114929725A CN 114929725 A CN114929725 A CN 114929725A CN 202180008565 A CN202180008565 A CN 202180008565A CN 114929725 A CN114929725 A CN 114929725A
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China
Prior art keywords
adalimumab
antibody
composition
stability
purified
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Pending
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CN202180008565.2A
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English (en)
Inventor
杨忠华
马一冬
邢振荣
蔺智勇
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Innovent Biologics Suzhou Co Ltd
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Innovent Biologics Suzhou Co Ltd
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Publication of CN114929725A publication Critical patent/CN114929725A/zh
Pending legal-status Critical Current

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    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K1/00General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14Extraction; Separation; Purification
    • C07K1/16Extraction; Separation; Purification by chromatography
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K1/00General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14Extraction; Separation; Purification
    • C07K1/16Extraction; Separation; Purification by chromatography
    • C07K1/18Ion-exchange chromatography
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K1/00General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14Extraction; Separation; Purification
    • C07K1/16Extraction; Separation; Purification by chromatography
    • C07K1/22Affinity chromatography or related techniques based upon selective absorption processes
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K1/00General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14Extraction; Separation; Purification
    • C07K1/36Extraction; Separation; Purification by a combination of two or more processes of different types
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons

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  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Genetics & Genomics (AREA)
  • Medicinal Chemistry (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Analytical Chemistry (AREA)
  • Immunology (AREA)
  • Peptides Or Proteins (AREA)

Abstract

一种阿达木单抗的纯化方法,以及由此纯化方法获得的稳定阿达木单抗组合物,和该组合物的医药用途。

Description

PCT国内申请,说明书已公开。

Claims (17)

  1. PCT国内申请,权利要求书已公开。
CN202180008565.2A 2020-01-08 2021-01-07 阿达木单抗纯化方法及其稳定组合物 Pending CN114929725A (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
CN202010017831 2020-01-08
CN2020100178315 2020-01-08
PCT/CN2021/070654 WO2021139720A1 (zh) 2020-01-08 2021-01-07 阿达木单抗纯化方法及其稳定组合物

Publications (1)

Publication Number Publication Date
CN114929725A true CN114929725A (zh) 2022-08-19

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CN202180008565.2A Pending CN114929725A (zh) 2020-01-08 2021-01-07 阿达木单抗纯化方法及其稳定组合物

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CN (1) CN114929725A (zh)
WO (1) WO2021139720A1 (zh)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014207763A1 (en) * 2013-06-25 2014-12-31 Cadila Healthcare Limited Purification process for monoclonal antibodies
US20150141623A1 (en) * 2012-04-20 2015-05-21 Abbvie, Inc. Protein purification methods to reduce acidic species
CN105051064A (zh) * 2013-01-24 2015-11-11 葛兰素史克知识产权开发有限公司 抗TNF-α抗原结合蛋白
CN109843904A (zh) * 2016-10-17 2019-06-04 恩泽生物科学有限公司 用于降低治疗性蛋白的异质性的连续方法

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2193145A4 (en) * 2007-08-28 2011-05-18 Abbott Biotech Ltd COMPOSITIONS AND METHODS COMPRISING BINDING PROTEINS FOR ADALIMUMAB

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20150141623A1 (en) * 2012-04-20 2015-05-21 Abbvie, Inc. Protein purification methods to reduce acidic species
CN105051064A (zh) * 2013-01-24 2015-11-11 葛兰素史克知识产权开发有限公司 抗TNF-α抗原结合蛋白
WO2014207763A1 (en) * 2013-06-25 2014-12-31 Cadila Healthcare Limited Purification process for monoclonal antibodies
CN109843904A (zh) * 2016-10-17 2019-06-04 恩泽生物科学有限公司 用于降低治疗性蛋白的异质性的连续方法

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WO2021139720A1 (zh) 2021-07-15

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