CN118641770A - 用于测定多聚体蛋白质的量和纯度的方法和色谱系统 - Google Patents

用于测定多聚体蛋白质的量和纯度的方法和色谱系统 Download PDF

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Publication number
CN118641770A
CN118641770A CN202410751862.1A CN202410751862A CN118641770A CN 118641770 A CN118641770 A CN 118641770A CN 202410751862 A CN202410751862 A CN 202410751862A CN 118641770 A CN118641770 A CN 118641770A
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China
Prior art keywords
antibody
affinity matrix
protein
impurity
homodimeric
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Pending
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CN202410751862.1A
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English (en)
Chinese (zh)
Inventor
M·佩龙
A·罗德里格斯
A·塔斯蒂安
H·巴克
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Regeneron Pharmaceuticals Inc
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Regeneron Pharmaceuticals Inc
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Publication of CN118641770A publication Critical patent/CN118641770A/zh
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    • 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
    • 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
    • B01D15/10—Selective adsorption, e.g. chromatography characterised by constructional or operational features
    • B01D15/18—Selective adsorption, e.g. chromatography characterised by constructional or operational features relating to flow patterns
    • B01D15/1864—Selective adsorption, e.g. chromatography characterised by constructional or operational features relating to flow patterns using two or more columns
    • B01D15/1871—Selective adsorption, e.g. chromatography characterised by constructional or operational features relating to flow patterns using two or more columns placed in series
    • 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
    • B01D15/3809—Affinity chromatography of the antigen-antibody type, e.g. protein A, G or L 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
    • 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
    • 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
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02—Column chromatography
    • G01N30/04—Preparation or injection of sample to be analysed
    • G01N30/06—Preparation
    • G01N30/14—Preparation by elimination of some components
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02—Column chromatography
    • G01N30/62—Detectors specially adapted therefor
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02—Column chromatography
    • G01N30/62—Detectors specially adapted therefor
    • G01N30/72—Mass spectrometers
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02—Column chromatography
    • G01N30/86—Signal analysis
    • G01N30/8624—Detection of slopes or peaks; baseline correction
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02—Column chromatography
    • G01N30/88—Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6803—General methods of protein analysis not limited to specific proteins or families of proteins
    • G01N33/6848—Methods of protein analysis involving mass spectrometry
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6854—Immunoglobulins
    • 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
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02—Column chromatography
    • G01N2030/022—Column chromatography characterised by the kind of separation mechanism
    • G01N2030/027—Liquid chromatography
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02—Column chromatography
    • G01N30/88—Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86
    • G01N2030/8809—Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86 analysis specially adapted for the sample
    • G01N2030/8813—Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86 analysis specially adapted for the sample biological materials
    • G01N2030/8831—Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86 analysis specially adapted for the sample biological materials involving peptides or proteins

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  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Immunology (AREA)
  • Molecular Biology (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Physics & Mathematics (AREA)
  • Medicinal Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Pathology (AREA)
  • General Physics & Mathematics (AREA)
  • Biophysics (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Urology & Nephrology (AREA)
  • Genetics & Genomics (AREA)
  • Food Science & Technology (AREA)
  • Cell Biology (AREA)
  • Biotechnology (AREA)
  • Microbiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Bioinformatics & Computational Biology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Spectroscopy & Molecular Physics (AREA)
  • Peptides Or Proteins (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Treatment Of Liquids With Adsorbents In General (AREA)
CN202410751862.1A 2018-08-17 2019-08-16 用于测定多聚体蛋白质的量和纯度的方法和色谱系统 Pending CN118641770A (zh)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US201862719323P 2018-08-17 2018-08-17
US62/719,323 2018-08-17
PCT/US2019/046769 WO2020037182A1 (en) 2018-08-17 2019-08-16 Method and chromatography system for determining amount and purity of a multimeric protein
CN201980063053.9A CN112771379B (zh) 2018-08-17 2019-08-16 用于测定多聚体蛋白质的量和纯度的方法和色谱系统

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CN201980063053.9A Active CN112771379B (zh) 2018-08-17 2019-08-16 用于测定多聚体蛋白质的量和纯度的方法和色谱系统

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US (2) US12152056B2 (enExample)
EP (1) EP3837552A1 (enExample)
JP (2) JP7527273B2 (enExample)
KR (2) KR102795000B1 (enExample)
CN (2) CN118641770A (enExample)
AU (2) AU2019322895B2 (enExample)
BR (1) BR112021002724A2 (enExample)
CA (1) CA3109362A1 (enExample)
EA (1) EA202190459A1 (enExample)
IL (2) IL280764B2 (enExample)
MX (1) MX2021001915A (enExample)
MY (1) MY207066A (enExample)
SG (1) SG11202101369XA (enExample)
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Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SG11202101369XA (en) * 2018-08-17 2021-03-30 Regeneron Pharma Method and chromatography system for determining amount and purity of a multimeric protein
AU2020293237A1 (en) * 2019-06-13 2022-01-06 Regeneron Pharmaceuticals, Inc. Methods for removing undesired components during multistage chromatographic processes
WO2022234412A1 (en) 2021-05-03 2022-11-10 Lupin Limited A process for purification of fc-fusion proteins
CN117761217A (zh) * 2023-12-22 2024-03-26 深圳市乐土生命科技投资有限公司 一种检测Fc轻链改造双抗或Fc融合蛋白表达量的方法
WO2026075981A1 (en) * 2024-10-01 2026-04-09 Regeneron Pharmaceuticals, Inc. Methods of analyzing heterodimeric proteins

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EP0826696B1 (de) 1996-09-03 2002-05-29 GSF-Forschungszentrum für Umwelt und Gesundheit GmbH Verwendung bi-und trispezifischer Antikörper zur Induktion einer Tumorimmunität
US7691645B2 (en) * 2001-01-09 2010-04-06 Agilent Technologies, Inc. Immunosubtraction method
SG149759A1 (en) * 2007-07-10 2009-02-27 Millipore Corp Media for affinity chromatography
WO2010030393A1 (en) * 2008-09-15 2010-03-18 Millipore Corporation Methods for quantifying protein leakage from protein based affinity chromatography resins
TWI507525B (zh) 2009-06-26 2015-11-11 Regeneron Pharma 具天然免疫球蛋白形式之易分離的雙專一性抗體
EP2633306B1 (en) 2010-10-27 2016-03-23 GE Healthcare Bio-Sciences AB Chromatography system with guard columns
WO2012074481A1 (en) * 2010-12-03 2012-06-07 Ge Healthcare Bio-Sciences Ab System and process for biopolymer chromatography
EP2500073A1 (en) 2011-03-17 2012-09-19 ChromaCon AG Method for identification and purification of multi-specific polypeptides
EP2656892A1 (en) 2012-04-23 2013-10-30 Merck Patent GmbH Chromatography method
EP2847224A4 (en) 2012-05-10 2016-04-27 Zymeworks Inc SINGLE ARM MONOVALENT ANTIBODY CONSTRUCTS AND USES THEREOF
AU2014226126B2 (en) * 2013-03-08 2019-02-14 Genzyme Corporation Continuous purification of therapeutic proteins
JP2015052533A (ja) 2013-09-06 2015-03-19 株式会社日立製作所 クロマトグラフィー装置およびクロマトグラフィー方法
AP2016009222A0 (en) 2013-11-04 2016-05-31 Glenmark Pharmaceuticals Sa Production of t cell retargeting hetero-dimeric immunoglobulins
AR101262A1 (es) * 2014-07-26 2016-12-07 Regeneron Pharma Plataforma de purificación para anticuerpos biespecíficos
BR112017018365A2 (pt) * 2015-03-13 2018-04-10 Bristol-Myers Squibb Company uso de lavagens alcalinas durante cromatografia para remoção de impurezas
EP3280444B1 (en) 2015-04-10 2024-05-08 Adimab, LLC Methods for purifying heterodimeric multispecific antibodies from parental homodimeric antibody species
GB201602156D0 (en) * 2016-02-05 2016-03-23 Jones Philip C And Boku University Of Natural Resources And Life Sciences Heterodimers and purification thereof
SG11202101369XA (en) * 2018-08-17 2021-03-30 Regeneron Pharma Method and chromatography system for determining amount and purity of a multimeric protein

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EA202190459A1 (ru) 2021-07-21
JP7527273B2 (ja) 2024-08-02
BR112021002724A2 (pt) 2021-07-20
US12152056B2 (en) 2024-11-26
EP3837552A1 (en) 2021-06-23
AU2019322895B2 (en) 2026-03-19
IL280764A (en) 2021-04-29
CA3109362A1 (en) 2020-02-20
MY207066A (en) 2025-01-28
JP2024156725A (ja) 2024-11-06
KR20250053213A (ko) 2025-04-21
JP2021534398A (ja) 2021-12-09
CN112771379B (zh) 2024-07-02
IL280764B1 (en) 2026-01-01
US20210382065A1 (en) 2021-12-09
WO2020037182A1 (en) 2020-02-20
AU2026204232A1 (en) 2026-06-18
IL325196A (en) 2026-02-01
US20200055894A1 (en) 2020-02-20
SG11202101369XA (en) 2021-03-30
AU2019322895A1 (en) 2021-03-11
KR20210045413A (ko) 2021-04-26
KR102795000B1 (ko) 2025-04-15
IL280764B2 (en) 2026-05-01
MX2021001915A (es) 2021-05-31
CN112771379A (zh) 2021-05-07

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