JP6702967B2 - 二重特異性抗体のための精製プラットフォーム - Google Patents
二重特異性抗体のための精製プラットフォーム Download PDFInfo
- Publication number
- JP6702967B2 JP6702967B2 JP2017525320A JP2017525320A JP6702967B2 JP 6702967 B2 JP6702967 B2 JP 6702967B2 JP 2017525320 A JP2017525320 A JP 2017525320A JP 2017525320 A JP2017525320 A JP 2017525320A JP 6702967 B2 JP6702967 B2 JP 6702967B2
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- Prior art keywords
- protein
- buffer
- affinity matrix
- affinity
- heterodimer
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Classifications
-
- 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
-
- 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
- B01D15/3819—Affinity chromatography of the nucleic acid-nucleic acid binding protein type
-
- 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
- B01D15/3828—Ligand exchange chromatography, e.g. complexation, chelation or metal interaction chromatography
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
- B01J39/00—Cation exchange; Use of material as cation exchangers; Treatment of material for improving the cation exchange properties
- B01J39/08—Use of material as cation exchangers; Treatment of material for improving the cation exchange properties
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
- B01J39/00—Cation exchange; Use of material as cation exchangers; Treatment of material for improving the cation exchange properties
- B01J39/26—Cation exchangers for chromatographic processes
-
- 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
- C07K1/22—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
-
- 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
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
- C07K16/12—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from bacteria
- C07K16/1267—Gram-positive bacteria
- C07K16/1271—Micrococcaceae (F); Staphylococcaceae (F), e.g. Staphylococcus (G)
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/10—Immunoglobulins specific features characterized by their source of isolation or production
- C07K2317/14—Specific host cells or culture conditions, e.g. components, pH or temperature
-
- 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
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/52—Constant or Fc region; Isotype
- C07K2317/526—CH3 domain
Landscapes
- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Health & Medical Sciences (AREA)
- Analytical Chemistry (AREA)
- Life Sciences & Earth Sciences (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Biophysics (AREA)
- General Health & Medical Sciences (AREA)
- Genetics & Genomics (AREA)
- Medicinal Chemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Immunology (AREA)
- Peptides Or Proteins (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201462029463P | 2014-07-26 | 2014-07-26 | |
| US62/029,463 | 2014-07-26 | ||
| PCT/US2015/041936 WO2016018740A2 (en) | 2014-07-26 | 2015-07-24 | Purification platform for bispecific antibodies |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2017524740A JP2017524740A (ja) | 2017-08-31 |
| JP2017524740A5 JP2017524740A5 (enExample) | 2020-01-30 |
| JP6702967B2 true JP6702967B2 (ja) | 2020-06-03 |
Family
ID=53836215
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2017525320A Active JP6702967B2 (ja) | 2014-07-26 | 2015-07-24 | 二重特異性抗体のための精製プラットフォーム |
Country Status (19)
| Country | Link |
|---|---|
| US (1) | US10626142B2 (enExample) |
| EP (2) | EP3912987B9 (enExample) |
| JP (1) | JP6702967B2 (enExample) |
| KR (1) | KR102440737B1 (enExample) |
| CN (1) | CN107074906B (enExample) |
| AR (1) | AR101262A1 (enExample) |
| AU (1) | AU2015298156B2 (enExample) |
| DK (2) | DK3912987T3 (enExample) |
| EA (1) | EA036154B1 (enExample) |
| ES (2) | ES2881026T3 (enExample) |
| FI (1) | FI3912987T3 (enExample) |
| IL (1) | IL255198B (enExample) |
| MX (1) | MX377558B (enExample) |
| MY (1) | MY187051A (enExample) |
| PL (2) | PL3912987T3 (enExample) |
| SG (2) | SG10201900661YA (enExample) |
| TW (1) | TWI704155B (enExample) |
| WO (1) | WO2016018740A2 (enExample) |
| ZA (1) | ZA201700622B (enExample) |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR101374454B1 (ko) | 2005-03-31 | 2014-03-17 | 추가이 세이야쿠 가부시키가이샤 | 회합제어에 의한 폴리펩티드 제조방법 |
| EP4793360A2 (en) | 2006-03-31 | 2026-08-19 | Chugai Seiyaku Kabushiki Kaisha | Methods for controlling blood pharmacokinetics of antibodies |
| ES2687808T3 (es) | 2007-09-26 | 2018-10-29 | Chugai Seiyaku Kabushiki Kaisha | Región constante de anticuerpo modificado |
| EP3127921A1 (en) | 2007-09-26 | 2017-02-08 | Chugai Seiyaku Kabushiki Kaisha | Method of modifying isoelectric point of antibody via amino acid substition in cdr |
| TWI544077B (zh) | 2009-03-19 | 2016-08-01 | 中外製藥股份有限公司 | Antibody constant region change body |
| TWI736437B (zh) | 2010-11-30 | 2021-08-11 | 日商中外製藥股份有限公司 | 細胞傷害誘導治療劑 |
| AR101262A1 (es) | 2014-07-26 | 2016-12-07 | Regeneron Pharma | Plataforma de purificación para anticuerpos biespecíficos |
| US11566082B2 (en) | 2014-11-17 | 2023-01-31 | Cytiva Bioprocess R&D Ab | Mutated immunoglobulin-binding polypeptides |
| JP7082484B2 (ja) | 2015-04-01 | 2022-06-08 | 中外製薬株式会社 | ポリペプチド異種多量体の製造方法 |
| EP3549606A1 (en) * | 2015-05-28 | 2019-10-09 | Bio-rad Laboratories, Inc. | Affinity ligands and methods relating thereto |
| SG11201803989WA (en) * | 2015-12-28 | 2018-06-28 | Chugai Pharmaceutical Co Ltd | Method for promoting efficiency of purification of fc region-containing polypeptide |
| AU2017255077B2 (en) | 2016-04-28 | 2024-05-16 | Chugai Seiyaku Kabushiki Kaisha | Antibody-containing preparation |
| WO2017194592A1 (en) | 2016-05-11 | 2017-11-16 | Ge Healthcare Bioprocess R&D Ab | Method of storing a separation matrix |
| JP7031934B2 (ja) | 2016-05-11 | 2022-03-08 | サイティバ・バイオプロセス・アールアンドディ・アクチボラグ | 分離マトリックス |
| JP7122974B2 (ja) | 2016-05-11 | 2022-08-22 | サイティバ・バイオプロセス・アールアンドディ・アクチボラグ | 変異免疫グロブリン結合ポリペプチド |
| US10654887B2 (en) | 2016-05-11 | 2020-05-19 | Ge Healthcare Bio-Process R&D Ab | Separation matrix |
| US10703774B2 (en) | 2016-09-30 | 2020-07-07 | Ge Healthcare Bioprocess R&D Ab | Separation method |
| US10730908B2 (en) | 2016-05-11 | 2020-08-04 | Ge Healthcare Bioprocess R&D Ab | Separation method |
| EP3455241B1 (en) | 2016-05-11 | 2022-02-23 | Cytiva BioProcess R&D AB | Method of cleaning and/or sanitizing a separation matrix |
| CA3026518A1 (en) * | 2016-06-17 | 2017-12-21 | Genentech, Inc. | Purification of multispecific antibodies |
| WO2018038469A1 (ko) * | 2016-08-20 | 2018-03-01 | (주)아이벤트러스 | 목적하는 이중특이성 항체의 선택적 생산 확인 방법 |
| KR101933656B1 (ko) | 2016-08-20 | 2018-12-28 | (주) 아이벤트러스 | 목적하는 이중특이성 항체의 선택적 생산 확인 방법 |
| US12448411B2 (en) | 2016-09-30 | 2025-10-21 | Cytiva Bioprocess R&D Ab | Separation method |
| JP7209298B2 (ja) | 2017-03-31 | 2023-01-20 | 公立大学法人奈良県立医科大学 | 血液凝固第viii因子の機能を代替する多重特異性抗原結合分子を含有する、血液凝固第ix因子異常症の予防および/または治療に用いられる医薬組成物 |
| KR20260090008A (ko) | 2017-11-01 | 2026-06-16 | 추가이 세이야쿠 가부시키가이샤 | 생물 활성이 저하된 항체 배리언트 및 아이소폼 |
| US11155575B2 (en) | 2018-03-21 | 2021-10-26 | Waters Technologies Corporation | Non-antibody high-affinity-based sample preparation, sorbent, devices and methods |
| GB201805142D0 (en) * | 2018-03-29 | 2018-05-16 | Ge Healthcare Bioprocess R&D Ab | Separation method |
| SG11202101369XA (en) * | 2018-08-17 | 2021-03-30 | Regeneron Pharma | Method and chromatography system for determining amount and purity of a multimeric protein |
| SG11202102713TA (en) * | 2018-09-21 | 2021-04-29 | Teneobio Inc | Methods for purifying heterodimeric, multispecific antibodies |
| WO2020066270A1 (ja) * | 2018-09-28 | 2020-04-02 | 株式会社カネカ | κ鎖可変領域を含む抗体および/または抗体断片の製造方法 |
| CA3116717A1 (en) | 2018-10-31 | 2020-05-07 | Regeneron Pharmaceuticals, Inc. | Method and system of identifying and quantifying a protein |
| CA3110377A1 (en) | 2018-11-21 | 2020-05-28 | Regeneron Pharmaceuticals, Inc. | Anti-staphylococcus antibodies and uses thereof |
| EP3887386A4 (en) * | 2018-11-26 | 2022-11-30 | North Carolina State University | PEPTIDE LIGANDS FOR CAPTURE OF HOST CELL PROTEINS |
| US11249089B2 (en) | 2018-12-12 | 2022-02-15 | Regeneron Pharmaceuticals, Inc. | System and method of analysis of a protein using liquid chromatography-mass spectrometry |
| JP7734075B2 (ja) | 2018-12-24 | 2025-09-04 | サノフイ | 疑似fabベースの多重特異性結合タンパク質 |
| EA202192422A1 (ru) | 2019-03-05 | 2021-12-09 | Ридженерон Фармасьютикалз, Инк. | Человеческий сывороточный альбумин в составах |
| CN113966343A (zh) | 2019-06-11 | 2022-01-21 | 瑞泽恩制药公司 | 结合PcrV的抗PcrV抗体、包含抗PcrV抗体的组合物及其使用方法 |
| AU2020293237A1 (en) * | 2019-06-13 | 2022-01-06 | Regeneron Pharmaceuticals, Inc. | Methods for removing undesired components during multistage chromatographic processes |
| IL309560B2 (en) | 2019-12-06 | 2025-05-01 | Regeneron Pharma | Anti-VEGF protein preparations and methods for their production |
| EP4141025A4 (en) * | 2019-12-26 | 2024-04-24 | ABL Bio, Inc. | Method for purifying biologically active peptide by using protein a affinity chromatography |
| KR102834449B1 (ko) | 2019-12-27 | 2025-07-15 | 케이에스광학주식회사 | 투명한 방탄 적층 구조물 |
| MX2022013812A (es) | 2020-05-08 | 2022-12-15 | Regeneron Pharma | Trampas y mini-trampas de vegf y metodos para el tratamiento de trastornos oculares y cancer. |
| WO2022082030A2 (en) | 2020-10-15 | 2022-04-21 | Gritstone Bio, Inc. | Antigen-binding proteins and related methods of use |
| WO2022155503A1 (en) | 2021-01-14 | 2022-07-21 | Gritstone Bio, Inc. | Multi-specific antibodies and methods of use |
| JP7875865B2 (ja) * | 2021-01-25 | 2026-06-18 | ユーハン・コーポレイション | 抗4-1bb/抗her2二重特異性抗体の精製方法 |
| GB202109246D0 (en) * | 2021-06-28 | 2021-08-11 | Cytiva Bioprocess R & D Ab | A method of separating bispecific antibodies |
| CN115960241B (zh) * | 2021-10-12 | 2026-05-05 | 苏州生物医药转化工程中心 | 一种针对表皮生长因子受体双特异性抗体的Protein A纯化保存方法 |
| EP4421089A4 (en) * | 2021-10-19 | 2026-01-07 | Alteogen Inc | METHOD FOR PURIFYING A FUSION PROTEIN HAVING AN IGG FC DOMAIN |
| KR20250028362A (ko) * | 2022-06-22 | 2025-02-28 | 씨티바 바이오프로세스 알&디 에이비 | 카파 경쇄-결합 대류 매트릭스 |
| WO2024123698A1 (en) | 2022-12-08 | 2024-06-13 | Regeneron Pharmaceuticals, Inc. | Methods to characterizing a fragment crystallizable domain of a bispecific antibody |
| WO2024153768A1 (en) * | 2023-01-20 | 2024-07-25 | Boehringer Ingelheim International Gmbh | Il-12 fc fusion proteins |
| CN116769044A (zh) * | 2023-07-11 | 2023-09-19 | 康日百奥生物科技(苏州)有限公司 | 抗cd3和cd19双特异性抗体蛋白及其层析纯化方法 |
| EP4788450A1 (en) * | 2023-10-04 | 2026-08-12 | Sartorius BIA Separations d.o.o. | Enhanced chromatographic separations of components in a mixture by employing chaotropic elution |
| WO2025111473A1 (en) | 2023-11-21 | 2025-05-30 | Regeneron Pharmaceuticals, Inc. | Covalently surface modified adeno-associated virus production by in vitro conjugation, and purification of covalently surface modified adeno-associated virus |
| WO2025131519A1 (en) * | 2023-12-21 | 2025-06-26 | Cytiva Bioprocess R&D Ab | Antibody separation with a vh3 binding separation matrix |
| WO2025173342A1 (ja) * | 2024-02-13 | 2025-08-21 | Jsr株式会社 | Fc融合タンパク質を精製するためのクロマトグラフィー用担体、及びそれを用いたFc融合タンパク質の精製方法 |
| WO2026075981A1 (en) * | 2024-10-01 | 2026-04-09 | Regeneron Pharmaceuticals, Inc. | Methods of analyzing heterodimeric proteins |
| WO2026112457A2 (en) | 2024-11-21 | 2026-05-28 | Regeneron Pharmaceuticals, Inc. | Heterodimeric antigen-binding molecules that bind to viral particles and uses thereof |
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|---|---|---|---|---|
| GB8626413D0 (en) | 1986-11-05 | 1986-12-03 | Gilliland L K | Antibodies |
| GB8626412D0 (en) | 1986-11-05 | 1986-12-03 | Clark M R | Antibodies |
| AU4116793A (en) | 1992-04-24 | 1993-11-29 | Board Of Regents, The University Of Texas System | Recombinant production of immunoglobulin-like domains in prokaryotic cells |
| US5945311A (en) | 1994-06-03 | 1999-08-31 | GSF--Forschungszentrumfur Umweltund Gesundheit | Method for producing heterologous bi-specific antibodies |
| US5731168A (en) | 1995-03-01 | 1998-03-24 | Genentech, Inc. | Method for making heteromultimeric polypeptides |
| DK0826695T3 (da) | 1996-09-03 | 2002-04-15 | Gsf Forschungszentrum Umwelt | Tilintetgørelse af kontaminerende tumorceller i stamcelletransplantater med bispecifikke antistoffer |
| EP0826696B1 (de) | 1996-09-03 | 2002-05-29 | GSF-Forschungszentrum für Umwelt und Gesundheit GmbH | Verwendung bi-und trispezifischer Antikörper zur Induktion einer Tumorimmunität |
| US20020062010A1 (en) | 1997-05-02 | 2002-05-23 | Genentech, Inc. | Method for making multispecific antibodies having heteromultimeric and common components |
| DE19725586C2 (de) | 1997-06-17 | 1999-06-24 | Gsf Forschungszentrum Umwelt | Verfahren zur Herstellung von Zellpräparaten zur Immunisierung mittels heterologer intakter bispezifischer und/oder trispezifischer Antikörper |
| ATE255420T1 (de) | 1998-09-25 | 2003-12-15 | Horst Lindhofer | Verwendung von tumorzellen zeitversetzt in kombination mit intakten antikörpern zur immunisierung |
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| BRPI0611600B8 (pt) * | 2005-06-17 | 2021-05-25 | Wyeth Corp | método para purificação de uma proteína tendo uma região fc a partir de um líquido fonte compreendendo a proteína e uma ou mais impurezas, e kit |
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| AU2010336277B2 (en) * | 2009-12-25 | 2015-02-19 | Chugai Seiyaku Kabushiki Kaisha | Polypeptide modification method for purifying polypeptide multimers |
| TWI736437B (zh) * | 2010-11-30 | 2021-08-11 | 日商中外製藥股份有限公司 | 細胞傷害誘導治療劑 |
| EP2500073A1 (en) * | 2011-03-17 | 2012-09-19 | ChromaCon AG | Method for identification and purification of multi-specific polypeptides |
| EP3517548A1 (en) * | 2012-03-13 | 2019-07-31 | NovImmune S.A. | Readily isolated bispecific antibodies with native immunoglobulin format |
| US20150239991A1 (en) * | 2012-09-25 | 2015-08-27 | Glenmark Pharmaceuticals S.A. | Purification of hetero-dimeric immunoglobulins |
| AR101262A1 (es) | 2014-07-26 | 2016-12-07 | Regeneron Pharma | Plataforma de purificación para anticuerpos biespecíficos |
-
2015
- 2015-07-21 AR ARP150102301A patent/AR101262A1/es active IP Right Grant
- 2015-07-23 TW TW104123813A patent/TWI704155B/zh active
- 2015-07-24 EP EP21170436.6A patent/EP3912987B9/en active Active
- 2015-07-24 MX MX2017001217A patent/MX377558B/es active IP Right Grant
- 2015-07-24 EP EP15750182.6A patent/EP3172221B1/en active Active
- 2015-07-24 WO PCT/US2015/041936 patent/WO2016018740A2/en not_active Ceased
- 2015-07-24 ES ES15750182T patent/ES2881026T3/es active Active
- 2015-07-24 KR KR1020177003803A patent/KR102440737B1/ko active Active
- 2015-07-24 DK DK21170436.6T patent/DK3912987T3/da active
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