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

    • 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)
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
PCT/IN2014/000421 WO2014207763A1 (en) 2013-06-25 2014-06-25 Purification process for monoclonal antibodies
IN2145MU2013 IN2013MU02145A (enExample) 2013-06-25 2014-06-25

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
US9062106B2 (en) 2011-04-27 2015-06-23 Abbvie Inc. Methods for controlling the galactosylation profile of recombinantly-expressed proteins
US9334319B2 (en) 2012-04-20 2016-05-10 Abbvie Inc. Low acidic species compositions
US9067990B2 (en) 2013-03-14 2015-06-30 Abbvie, Inc. Protein purification using displacement chromatography
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
WO2014151878A2 (en) 2013-03-14 2014-09-25 Abbvie Inc. Methods for modulating protein glycosylation profiles of recombinant protein therapeutics using monosaccharides and oligosacharides
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
CA2926588C (en) 2013-10-16 2020-07-21 Oncobiologics, Inc. Buffer formulations for enhanced antibody stability
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
TW201628649A (zh) 2014-10-09 2016-08-16 再生元醫藥公司 減少醫藥調配物中微可見顆粒之方法
EP3247718B1 (en) 2015-01-21 2021-09-01 Outlook Therapeutics, Inc. Modulation of charge variants in a monoclonal antibody composition
BR112017018365A2 (pt) * 2015-03-13 2018-04-10 Bristol-Myers Squibb Company uso de lavagens alcalinas durante cromatografia para remoção de impurezas
CN116063375A (zh) * 2015-08-21 2023-05-05 豪夫迈·罗氏有限公司 在亲和层析中减少宿主细胞蛋白的方法
JP7073253B2 (ja) 2015-08-21 2022-05-23 エフ．ホフマン－ラ ロシュ アーゲー アフィニティークロマトグラフィーにおける宿主細胞タンパク質の低減方法
CN107849122B (zh) * 2015-08-21 2022-01-25 豪夫迈·罗氏有限公司 用低电导率洗涤缓冲液进行亲和层析纯化
WO2017136433A1 (en) 2016-02-03 2017-08-10 Oncobiologics, Inc. Buffer formulations for enhanced antibody stability
CA3031742A1 (en) 2016-08-16 2018-02-22 Regeneron Pharmaceuticals, Inc. Methods for quantitating individual antibodies from a mixture
EP4071469B1 (en) 2016-10-25 2025-04-09 Regeneron Pharmaceuticals, Inc. Methods for chromatography data analysis
MX2019004957A (es) * 2016-10-28 2019-06-24 Merck Sharp & Dohme Proceso de purificacion para la eliminacion de variantes de anticuerpos con sulfatacion de tirosina; composiciones purificadas.
US20200087390A1 (en) 2016-12-21 2020-03-19 Amgen Inc. Anti-tnf alpha antibody formulations
EA201900326A1 (ru) 2016-12-23 2019-11-29 Усовершенствованные способы повышения продуктивности антител в культурах клеток млекопитающих и сведения к минимуму агрегации в процессах выделения и очистки, получения композиций и стабильные композиции антител, полученные этими способами
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
CA3073935A1 (en) 2017-09-19 2019-03-28 Regeneron Pharmaceuticals, Inc. Methods of reducing particle formation and compositions formed thereby
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
EP3769083A1 (en) 2018-03-21 2021-01-27 Waters Technologies Corporation Non-antibody high-affinity-based sample preparation, sorbents, devices and methods
CA3095899A1 (en) * 2018-04-02 2019-10-10 Amgen Inc. Erenumab compositions and uses thereof
TW202448568A (zh) 2018-07-02 2024-12-16 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
TW202045527A (zh) * 2019-01-23 2020-12-16 日商第一三共股份有限公司 包含使用活性碳材料之步驟之抗體純化方法
US20220411466A1 (en) * 2019-11-22 2022-12-29 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
JP4469933B2 (ja) 1998-05-06 2010-06-02 ジェネンテック， インコーポレイテッド イオン交換クロマトグラフィによるタンパク質精製
EP1308456B1 (en) 1998-05-06 2007-08-22 Genentech, Inc. Antibody purification by ion exchange chromatography
PT1084136E (pt) * 1998-06-01 2004-12-31 Genentech Inc Separacao de monomeros de anticorpos dos seus multimeros atraves da utilizacao de cromatografia de troca ionica
US20060257972A1 (en) 2003-03-31 2006-11-16 Takashi Ishihara Purification of human monoclonal antibody and human polyclonal antibody
NZ544924A (en) 2003-06-27 2009-03-31 Biogen Idec Inc Modified binding molecules comprising connecting peptides
SE0400501D0 (sv) 2004-02-27 2004-02-27 Amersham Biosciences Ab Antibody purification
MX2007011129A (es) * 2005-03-11 2007-11-06 Wyeth Corp Un metodo de cromatografia de particion debil.
US7825223B2 (en) 2005-06-17 2010-11-02 Janssen Alzheimer Immunotherapy Methods of purifying anti A β antibodies
US8263750B2 (en) 2006-03-16 2012-09-11 Amgen Inc. Method for purifying a protein using protein-A affinity chromatography using an intermediate wash step
CN102887955A (zh) 2006-04-05 2013-01-23 艾博特生物技术有限公司 抗体纯化
MX2009002576A (es) 2006-09-08 2009-03-20 Wyeth Corp Lavado de arginina en purificacion de proteina utilizando cromatografia de afinidad.
US8216571B2 (en) 2007-10-22 2012-07-10 Schering Corporation Fully human anti-VEGF antibodies and methods of using
WO2010030222A1 (en) 2008-09-12 2010-03-18 Ge Healthcare Bio-Sciences Ab Enhanced protein aggregate removal with multimodal anion exchangers 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
TW201024318A (en) * 2008-10-20 2010-07-01 Abbott Lab Isolation and purification of antibodies using protein A affinity chromatography
SI3037104T1 (sl) 2009-10-20 2020-10-30 Abbvie Inc. Izolacija in prečiščevanje protiteles anti-IL-13 z uporabo afinitetne kromatografije beljakovine A
US20130178608A1 (en) * 2009-12-29 2013-07-11 Samir Kulkarni Protein purification by ion exchange
EP2526114B1 (de) 2010-01-22 2014-06-18 Boehringer Ingelheim International GmbH Chromatographisches verfahren zur aufreinigung von fc enthaltenden proteinen
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
KR20130142128A (ko) * 2010-10-11 2013-12-27 애브비 인코포레이티드 단백질의 정제 방법
EP3578522A1 (en) * 2010-12-06 2019-12-11 Pall Corporation 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
WO2012176158A1 (en) * 2011-06-24 2012-12-27 Dr. Reddy's Laboratories Limited 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
ES2964601T3 (es) * 2013-03-14 2024-04-08 Amgen Inc Eliminación de ligando de purificación por afinidad filtrado
WO2014209508A1 (en) 2013-05-13 2014-12-31 Medimmune, Llc Separation of recombinant polyclonal antibody multimers with minimal separation of monomers
AR096713A1 (es) 2013-06-25 2016-01-27 Cadila Healthcare Ltd Proceso de purificación para anticuerpos monoclonales

Also Published As

Publication number Publication date
AR096713A1 (es) 2016-01-27
EA201592192A1 (ru) 2016-07-29
EP3013849B1 (en) 2017-09-13
US20160115195A1 (en) 2016-04-28
JP6039828B2 (ja) 2016-12-07
TWI596107B (zh) 2017-08-21
IL242649A (en) 2016-03-31
CA2911874A1 (en) 2014-12-31
AU2014300486B2 (en) 2016-06-30
CN105263947A (zh) 2016-01-20
TW201512217A (zh) 2015-04-01
WO2014207763A1 (en) 2014-12-31
JP2016525500A (ja) 2016-08-25
AU2014300486A1 (en) 2015-11-26
IN2013MU02145A (enExample) 2015-06-05
EP3013849A1 (en) 2016-05-04
BR112015031196A2 (pt) 2017-07-25
KR20160003311A (ko) 2016-01-08
SG11201509502XA (en) 2015-12-30
US9708365B2 (en) 2017-07-18
KR101683415B1 (ko) 2016-12-06
MX2015016586A (es) 2016-03-16
NZ714079A (en) 2017-05-26
HK1217344A1 (zh) 2017-01-06
MX350610B (es) 2017-09-11

Similar Documents

Publication Publication Date Title
IL242649A (en) Purification process of monoclonal antibody
IL242408B (en) A continuous multistep step for antibody purification
PT3004163T (pt) Método para purificação de anticorpo
ZA201509334B (en) Improved process for production of monoclonal antibodies
SG11201509361TA (en) Novel antibodies
SG11201510653YA (en) Anti-fcrh5 antibodies
GB201322583D0 (en) Antibodies
ZA201506568B (en) Anti-tnf-anti-il-17 bispecific antibodies
EP3083698A4 (en) Monoclonal anti-tk1 antibodies
IL240753A0 (en) Antibody purification methods
IL244043A0 (en) Antibodies
SG11201505204VA (en) Protein purification process
GB201308658D0 (en) Antibodies
GB201315486D0 (en) Antibodies
IL239689A0 (en) A method for producing antibodies
IL245488B (en) Anti- ccl17 antibodies
SG11201607098SA (en) Antibody purification process
IL235483A0 (en) Crystallization methods for purification of monoclonal antibodies
ZA201600424B (en) Purification process for pth
GB201301384D0 (en) Method for antibody production
GB201318283D0 (en) Antibodies