ZA201508258B - Purification process for monoclonal antibodies - Google Patents

Purification process for monoclonal antibodies

Info

Publication number
ZA201508258B
ZA201508258B ZA2015/08258A ZA201508258A ZA201508258B ZA 201508258 B ZA201508258 B ZA 201508258B ZA 2015/08258 A ZA2015/08258 A ZA 2015/08258A ZA 201508258 A ZA201508258 A ZA 201508258A ZA 201508258 B ZA201508258 B ZA 201508258B
Authority
ZA
South Africa
Prior art keywords
monoclonal antibodies
purification process
purification
monoclonal
antibodies
Prior art date
Application number
ZA2015/08258A
Other languages
English (en)
Inventor
Avanish Kumar Singh
Sanjay Bandyopadhyay
Sanjeev Kumar Mendiratta
Original Assignee
Cadila Healthcare Ltd
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=51655799&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=ZA201508258(B) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Cadila Healthcare Ltd filed Critical Cadila Healthcare Ltd
Publication of ZA201508258B publication Critical patent/ZA201508258B/en

Links

Classifications

    • 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
    • C07K16/06Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies from serum
    • C07K16/065Purification, fragmentation
    • 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
    • C07K16/241Tumor Necrosis Factors
    • 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
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2863Immunoglobulins [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
    • 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
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2887Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against CD20
    • 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
    • C07K16/32Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against translation products of oncogenes
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24Immunoglobulins 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)
ZA2015/08258A 2013-06-25 2015-11-09 Purification process for monoclonal antibodies ZA201508258B (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
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 (1)

Publication Number Publication Date
ZA201508258B true ZA201508258B (en) 2017-03-29

Family

ID=51655799

Family Applications (1)

Application Number Title Priority Date Filing Date
ZA2015/08258A ZA201508258B (en) 2013-06-25 2015-11-09 Purification process for monoclonal antibodies

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)

Families Citing this family (57)

* Cited by examiner, † Cited by third party
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
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

Family Cites Families (30)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
AU760048B2 (en) 1998-05-06 2003-05-08 Genentech Inc. Protein purification by ion exchange chromatography
EP1308456B1 (en) 1998-05-06 2007-08-22 Genentech, Inc. Antibody purification by ion exchange chromatography
JP2002517406A (ja) * 1998-06-01 2002-06-18 ジェネンテック・インコーポレーテッド イオン交換クロマトグラフィーの使用による、凝集体からのタンパク質モノマーの分離
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
WO2006099308A2 (en) 2005-03-11 2006-09-21 Wyeth A method of weak partitioning chromatography
TW200740839A (en) 2005-06-17 2007-11-01 Wyeth Corp Methods of purifying Fc region containing proteins
WO2007109163A2 (en) 2006-03-16 2007-09-27 Amgen Inc Wash buffer and method of using
NZ611859A (en) 2006-04-05 2014-12-24 Abbvie Biotechnology Ltd Antibody purification
CL2007002615A1 (es) 2006-09-08 2008-04-18 Wyeth Corp Metodos para aislar o purificar un producto que comprende poner el producto enlazado en contacto con al menos una solucion de lavado que comprende arginina y luego eluir el producto; y dicho producto.
JP2011500086A (ja) * 2007-10-22 2011-01-06 シェーリング コーポレイション 完全ヒト抗vegf抗体および使用方法
US20110166332A1 (en) 2008-09-12 2011-07-07 Ge Healthcare Bio-Sciences Ab Enhanced antibody aggregate removal with capto adhere in the presence of protein-excluded zwitterions
US20100069617A1 (en) 2008-09-12 2010-03-18 Ge Healthcare Bio-Sciences Ab Enhanced protein aggregate removal by mixed mode chromatography on hydrophobic interaction media in the presence of protein-excluded zwitterions
NZ592095A (en) 2008-10-20 2013-01-25 Abbott Lab Isolation and purification of il-12 and tnf-alpha antibodies using protein a affinity chromatography
EP3037104B1 (en) 2009-10-20 2020-05-27 AbbVie Inc. Isolation and purification of anti-il-13 antibodies using protein a affinity chromatography
WO2011090719A2 (en) * 2009-12-29 2011-07-28 Dr. Reddy's Laboratories Ltd. Protein purification by ion exchange
CA2784959C (en) 2010-01-22 2018-06-26 Boehringer Ingelheim International Gmbh Chromatographic method for purifying fc-containing proteins
CN102179237A (zh) * 2010-04-26 2011-09-14 无锡加莱克色谱科技有限公司 一种用于分离、提纯单克隆抗体和抗体球蛋白的亲和色谱填料及其制备方法
SG189872A1 (en) 2010-10-11 2013-06-28 Abbvie Inc Processes for purification of proteins
US20130260419A1 (en) * 2010-12-06 2013-10-03 Thomas C. Ransohoff Continuous processing methods for biological products
US20120238730A1 (en) 2011-03-15 2012-09-20 Abbott Laboratories Integrated approach to the isolation and purification of antibodies
EP2723759A4 (en) * 2011-06-24 2015-01-28 Reddys Lab Ltd Dr PURIFICATION OF CHIMERIC PROTEIN
US20140288278A1 (en) * 2011-10-31 2014-09-25 Joseph Nti-Gyabaah Chromatography process for resolving heterogeneous antibody aggregates
WO2013075740A1 (en) 2011-11-23 2013-05-30 Sanofi Antibody purification method
PL3395423T3 (pl) * 2013-03-14 2024-03-18 Amgen Inc. Usuwanie wypłukanych ligandów do oczyszczania na zasadzie powinowactwa
HK1222871A1 (zh) 2013-05-13 2017-07-14 Medimmune, Llc 具有最小单体分离的重组多克隆抗体多聚体的分离
AR096713A1 (es) 2013-06-25 2016-01-27 Cadila Healthcare Ltd Proceso de purificación para anticuerpos monoclonales

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
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
JP6039828B2 (ja) 2016-12-07
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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