JP6039828B2 - モノクローナル抗体の精製方法 - Google Patents
モノクローナル抗体の精製方法 Download PDFInfo
- Publication number
- JP6039828B2 JP6039828B2 JP2015563045A JP2015563045A JP6039828B2 JP 6039828 B2 JP6039828 B2 JP 6039828B2 JP 2015563045 A JP2015563045 A JP 2015563045A JP 2015563045 A JP2015563045 A JP 2015563045A JP 6039828 B2 JP6039828 B2 JP 6039828B2
- Authority
- JP
- Japan
- Prior art keywords
- antibody
- column
- wash
- chromatography
- protein
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Fee Related
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Classifications
-
- 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
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/06—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies from serum
- C07K16/065—Purification, fragmentation
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/24—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
- C07K16/241—Tumor Necrosis Factors
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2863—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for growth factors, growth regulators
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2887—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against CD20
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/32—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against translation products of oncogenes
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
- C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
- C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
Landscapes
- Chemical & Material Sciences (AREA)
- Health & Medical Sciences (AREA)
- Organic Chemistry (AREA)
- Immunology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Biochemistry (AREA)
- General Health & Medical Sciences (AREA)
- Genetics & Genomics (AREA)
- Medicinal Chemistry (AREA)
- Molecular Biology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biophysics (AREA)
- Analytical Chemistry (AREA)
- Oncology (AREA)
- Peptides Or Proteins (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Cell Biology (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IN2145/MUM/2013 | 2013-06-25 | ||
| IN2145MU2013 IN2013MU02145A (enExample) | 2013-06-25 | 2014-06-25 | |
| PCT/IN2014/000421 WO2014207763A1 (en) | 2013-06-25 | 2014-06-25 | Purification process for monoclonal antibodies |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JP2016525500A JP2016525500A (ja) | 2016-08-25 |
| JP6039828B2 true JP6039828B2 (ja) | 2016-12-07 |
Family
ID=51655799
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2015563045A Expired - Fee Related JP6039828B2 (ja) | 2013-06-25 | 2014-06-25 | モノクローナル抗体の精製方法 |
Country Status (19)
| Country | Link |
|---|---|
| US (1) | US9708365B2 (enExample) |
| EP (1) | EP3013849B1 (enExample) |
| JP (1) | JP6039828B2 (enExample) |
| KR (1) | KR101683415B1 (enExample) |
| CN (1) | CN105263947A (enExample) |
| AR (1) | AR096713A1 (enExample) |
| AU (1) | AU2014300486B2 (enExample) |
| BR (1) | BR112015031196A2 (enExample) |
| CA (1) | CA2911874A1 (enExample) |
| EA (1) | EA201592192A1 (enExample) |
| HK (1) | HK1217344A1 (enExample) |
| IL (1) | IL242649A (enExample) |
| IN (1) | IN2013MU02145A (enExample) |
| MX (1) | MX350610B (enExample) |
| NZ (1) | NZ714079A (enExample) |
| SG (1) | SG11201509502XA (enExample) |
| TW (1) | TWI596107B (enExample) |
| WO (1) | WO2014207763A1 (enExample) |
| ZA (1) | ZA201508258B (enExample) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH088818Y2 (ja) | 1989-12-21 | 1996-03-13 | 株式会社イナックス | タイル用捺印装置 |
Families Citing this family (56)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| TWI398554B (zh) * | 2010-07-29 | 2013-06-11 | Zhen Ding Technology Co Ltd | 電鍍裝置 |
| WO2012149197A2 (en) | 2011-04-27 | 2012-11-01 | Abbott Laboratories | Methods for controlling the galactosylation profile of recombinantly-expressed proteins |
| US9067990B2 (en) | 2013-03-14 | 2015-06-30 | Abbvie, Inc. | Protein purification using displacement chromatography |
| US9150645B2 (en) | 2012-04-20 | 2015-10-06 | Abbvie, Inc. | Cell culture methods to reduce acidic species |
| US9181572B2 (en) | 2012-04-20 | 2015-11-10 | Abbvie, Inc. | Methods to modulate lysine variant distribution |
| US9249182B2 (en) | 2012-05-24 | 2016-02-02 | Abbvie, Inc. | Purification of antibodies using hydrophobic interaction chromatography |
| US9512214B2 (en) | 2012-09-02 | 2016-12-06 | Abbvie, Inc. | Methods to control protein heterogeneity |
| SG11201507230PA (en) | 2013-03-12 | 2015-10-29 | Abbvie Inc | Human antibodies that bind human tnf-alpha and methods of preparing the same |
| US10023608B1 (en) | 2013-03-13 | 2018-07-17 | Amgen Inc. | Protein purification methods to remove impurities |
| US9017687B1 (en) | 2013-10-18 | 2015-04-28 | Abbvie, Inc. | Low acidic species compositions and methods for producing and using the same using displacement chromatography |
| US9499614B2 (en) | 2013-03-14 | 2016-11-22 | Abbvie Inc. | Methods for modulating protein glycosylation profiles of recombinant protein therapeutics using monosaccharides and oligosaccharides |
| AR096713A1 (es) | 2013-06-25 | 2016-01-27 | Cadila Healthcare Ltd | Proceso de purificación para anticuerpos monoclonales |
| WO2015051293A2 (en) | 2013-10-04 | 2015-04-09 | Abbvie, Inc. | Use of metal ions for modulation of protein glycosylation profiles of recombinant proteins |
| JP6526025B2 (ja) | 2013-10-16 | 2019-06-05 | オンコバイオロジクス,インコーポレイティド | 抗体安定性を増強する緩衝液製剤 |
| US9181337B2 (en) | 2013-10-18 | 2015-11-10 | Abbvie, Inc. | Modulated lysine variant species compositions and methods for producing and using the same |
| US9085618B2 (en) | 2013-10-18 | 2015-07-21 | Abbvie, Inc. | Low acidic species compositions and methods for producing and using the same |
| US20150139988A1 (en) | 2013-11-15 | 2015-05-21 | Abbvie, Inc. | Glycoengineered binding protein compositions |
| AR102198A1 (es) | 2014-10-09 | 2017-02-08 | Regeneron Pharma | Proceso para reducir partículas subvisibles en una formulación farmacéutica |
| US10696735B2 (en) | 2015-01-21 | 2020-06-30 | Outlook Therapeutics, Inc. | Modulation of charge variants in a monoclonal antibody composition |
| CA2978095C (en) * | 2015-03-13 | 2022-02-15 | Bristol-Myers Squibb Company | Use of alkaline washes during chromatography to remove impurities |
| EP3337817B1 (en) | 2015-08-21 | 2021-09-15 | F. Hoffmann-La Roche AG | Method for the reduction of host cell proteins in affinity chromatography |
| JP7084301B2 (ja) * | 2015-08-21 | 2022-06-14 | エフ.ホフマン-ラ ロシュ アーゲー | 低伝導率洗浄緩衝液を用いたアフィニティークロマトグラフィー精製方法 |
| WO2017032686A1 (en) * | 2015-08-21 | 2017-03-02 | F. Hoffmann-La Roche Ag | Method for the reduction of host cell proteins in affinity chromatography |
| MX2018009341A (es) | 2016-02-03 | 2019-05-15 | Oncobiologics Inc | Formulaciones tamponadas para una mayor estabilidad de anticuerpos. |
| JP2019529350A (ja) | 2016-08-16 | 2019-10-17 | リジェネロン・ファーマシューティカルズ・インコーポレイテッドRegeneron Pharmaceuticals, Inc. | 混合物から個々の抗体を定量する方法 |
| BR112019006689A2 (pt) | 2016-10-25 | 2019-06-25 | Regeneron Pharma | métodos e sistemas para análise de dados de cromatografia |
| BR112019007856A8 (pt) * | 2016-10-28 | 2023-04-11 | Merck Sharp & Dohme | Composição, e, método para remover anticorpos de tirosina sulfatada ou fragmentos de ligação a antígeno dos mesmos |
| EP3824906A1 (en) | 2016-12-21 | 2021-05-26 | Amgen Inc. | Anti-tnf alpha antibody formulations |
| RS63533B1 (sr) | 2016-12-23 | 2022-09-30 | Serum Institute Of India Pvt Ltd | Postupci za povećanje produktivnosti antitela u kulturi sisarskih ćelija i smanjenje agregacije tokom nishodne obrade, postupci formulacije i rezultujuće stabilne formulacije antitela |
| KR102087823B1 (ko) * | 2017-05-16 | 2020-03-13 | 에이치케이이노엔 주식회사 | 친화성 크로마토그래피를 이용한 항체 또는 항체절편 정제 방법 |
| EP3431168A1 (en) * | 2017-07-19 | 2019-01-23 | Bayer Aktiengesellschaft | Élimination de médicament non lié après couplage conjugué anticorps-médicament |
| KR102798879B1 (ko) | 2017-09-19 | 2025-04-30 | 리제너론 파아마슈티컬스, 인크. | 입자 형성을 감소시키는 방법 및 그것에 의해 형성된 조성물 |
| CN108101987A (zh) * | 2017-11-17 | 2018-06-01 | 安徽未名生物医药有限公司 | 一种重组抗TNF-α全人源单克隆抗体的纯化方法 |
| CN110128538B (zh) * | 2018-02-09 | 2022-08-26 | 鲁南制药集团股份有限公司 | 一种纯化抗cd20人鼠嵌合单克隆抗体的方法 |
| CN119881293A (zh) | 2018-03-21 | 2025-04-25 | 沃特世科技公司 | 基于非抗体高亲和力的样品制备、吸附剂、装置和方法 |
| AR114722A1 (es) * | 2018-04-02 | 2020-10-07 | Amgen Inc | Composiciones de erenumab y usos de las mismas |
| 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 |
| EP4559485A3 (en) * | 2018-07-19 | 2025-08-06 | Ichnos Sciences S.A. | Liquid antibody formulation |
| KR102337683B1 (ko) * | 2018-09-21 | 2021-12-13 | 주식회사 녹십자 | 고효율 항-tfpi 항체 조성물 |
| CN111072773A (zh) * | 2018-10-19 | 2020-04-28 | 菲鹏生物股份有限公司 | 抗体的纯化方法、抗体和应用 |
| WO2020084503A1 (en) | 2018-10-26 | 2020-04-30 | Cadila Healthcare Limited | A composition comprising antibody with reduced level of basic variants thereof |
| EP3643322A1 (en) * | 2018-10-26 | 2020-04-29 | Mabion SA | Low aggregate anti cd20 ligand formulation |
| CN109320611B (zh) * | 2018-10-31 | 2022-06-03 | 鼎康(武汉)生物医药有限公司 | 一种人鼠嵌合单克隆抗体生物类似药的纯化方法 |
| CN111153993B (zh) * | 2018-11-07 | 2024-06-28 | 正大天晴药业集团南京顺欣制药有限公司 | 抗TNF-α单克隆抗体的制备方法 |
| CN109336969B (zh) * | 2018-11-09 | 2021-02-12 | 杭州奕安济世生物药业有限公司 | 一种抗体的纯化方法 |
| CN111269316B (zh) * | 2018-12-04 | 2024-06-28 | 正大天晴药业集团南京顺欣制药有限公司 | 抗her2单克隆抗体的纯化方法 |
| KR20210118815A (ko) * | 2019-01-23 | 2021-10-01 | 다이이찌 산쿄 가부시키가이샤 | 활성탄 재료를 사용하는 공정을 포함하는 항체 정제 방법 |
| EP4061825A1 (en) * | 2019-11-22 | 2022-09-28 | MorphoSys AG | Method to increase antibody yield during ion exchange chromatography |
| CN114929725A (zh) * | 2020-01-08 | 2022-08-19 | 信达生物制药(苏州)有限公司 | 阿达木单抗纯化方法及其稳定组合物 |
| KR102154952B1 (ko) * | 2020-02-21 | 2020-09-10 | 프레스티지바이오로직스 주식회사 | 아달리무맙의 Non-Protein A 정제방법 |
| WO2022245306A1 (en) * | 2021-05-20 | 2022-11-24 | Arven Ilac Sanayi Ve Ticaret Anonim Sirketi | Protein purification by affinity chromatography |
| WO2023007497A1 (en) | 2021-07-27 | 2023-02-02 | Ariel Scientific Innovations Ltd. | Large scale purification of antibodies |
| CN114133446A (zh) * | 2021-12-31 | 2022-03-04 | 方坦思(上海)生物医药有限公司 | 单克隆抗体的纯化方法 |
| CN115491328A (zh) * | 2022-08-31 | 2022-12-20 | 深圳市卫光生物制品股份有限公司 | 一种大肠杆菌表达蛋白及其表达纯化方法 |
| EP4335869A1 (en) | 2022-09-07 | 2024-03-13 | Bio T Biyoteknoloji Cozumleri Ve Uretim Anonim | Resin and chromatography column that purifies antibodies with protease resistant small peptides |
| CN118725127B (zh) * | 2024-07-11 | 2025-11-28 | 信立泰(苏州)药业有限公司 | 一种抗pcsk9单克隆抗体的分离纯化方法 |
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| US5429746A (en) * | 1994-02-22 | 1995-07-04 | Smith Kline Beecham Corporation | Antibody purification |
| US5641870A (en) * | 1995-04-20 | 1997-06-24 | Genentech, Inc. | Low pH hydrophobic interaction chromatography for antibody purification |
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| WO2004087761A1 (ja) | 2003-03-31 | 2004-10-14 | Kirin Beer Kabushiki Kaisha | ヒトモノクローナル抗体およびヒトポリクローナル抗体の精製 |
| JP5091476B2 (ja) | 2003-06-27 | 2012-12-05 | バイオジェン・アイデック・エムエイ・インコーポレイテッド | 均質な抗体溶液の生成のための疎水性相互作用クロマトグラフィーまたはヒンジ領域改変の使用 |
| SE0400501D0 (sv) | 2004-02-27 | 2004-02-27 | Amersham Biosciences Ab | Antibody purification |
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-
2014
- 2014-06-24 AR ARP140102380A patent/AR096713A1/es unknown
- 2014-06-24 TW TW103121726A patent/TWI596107B/zh not_active IP Right Cessation
- 2014-06-25 EP EP14777867.4A patent/EP3013849B1/en not_active Revoked
- 2014-06-25 MX MX2015016586A patent/MX350610B/es active IP Right Grant
- 2014-06-25 JP JP2015563045A patent/JP6039828B2/ja not_active Expired - Fee Related
- 2014-06-25 AU AU2014300486A patent/AU2014300486B2/en not_active Ceased
- 2014-06-25 SG SG11201509502XA patent/SG11201509502XA/en unknown
- 2014-06-25 IN IN2145MU2013 patent/IN2013MU02145A/en unknown
- 2014-06-25 CA CA2911874A patent/CA2911874A1/en not_active Abandoned
- 2014-06-25 BR BR112015031196A patent/BR112015031196A2/pt not_active IP Right Cessation
- 2014-06-25 WO PCT/IN2014/000421 patent/WO2014207763A1/en not_active Ceased
- 2014-06-25 NZ NZ714079A patent/NZ714079A/en not_active IP Right Cessation
- 2014-06-25 US US14/895,432 patent/US9708365B2/en active Active
- 2014-06-25 EA EA201592192A patent/EA201592192A1/ru unknown
- 2014-06-25 CN CN201480031532.XA patent/CN105263947A/zh active Pending
- 2014-06-25 KR KR1020157035759A patent/KR101683415B1/ko not_active Expired - Fee Related
- 2014-06-25 HK HK16105366.7A patent/HK1217344A1/zh unknown
-
2015
- 2015-11-09 ZA ZA2015/08258A patent/ZA201508258B/en unknown
- 2015-11-18 IL IL242649A patent/IL242649A/en not_active IP Right Cessation
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH088818Y2 (ja) | 1989-12-21 | 1996-03-13 | 株式会社イナックス | タイル用捺印装置 |
Also Published As
| Publication number | Publication date |
|---|---|
| AU2014300486A1 (en) | 2015-11-26 |
| KR101683415B1 (ko) | 2016-12-06 |
| US9708365B2 (en) | 2017-07-18 |
| IN2013MU02145A (enExample) | 2015-06-05 |
| SG11201509502XA (en) | 2015-12-30 |
| ZA201508258B (en) | 2017-03-29 |
| AU2014300486B2 (en) | 2016-06-30 |
| CN105263947A (zh) | 2016-01-20 |
| TW201512217A (zh) | 2015-04-01 |
| US20160115195A1 (en) | 2016-04-28 |
| KR20160003311A (ko) | 2016-01-08 |
| TWI596107B (zh) | 2017-08-21 |
| WO2014207763A1 (en) | 2014-12-31 |
| NZ714079A (en) | 2017-05-26 |
| IL242649A (en) | 2016-03-31 |
| AR096713A1 (es) | 2016-01-27 |
| HK1217344A1 (zh) | 2017-01-06 |
| EP3013849A1 (en) | 2016-05-04 |
| EP3013849B1 (en) | 2017-09-13 |
| JP2016525500A (ja) | 2016-08-25 |
| BR112015031196A2 (pt) | 2017-07-25 |
| EA201592192A1 (ru) | 2016-07-29 |
| MX350610B (es) | 2017-09-11 |
| CA2911874A1 (en) | 2014-12-31 |
| MX2015016586A (es) | 2016-03-16 |
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