BRPI1010119A2 - "método de produção de composição de anticorpo e uso de cromatografia de troca de íons analítica" - Google Patents

"método de produção de composição de anticorpo e uso de cromatografia de troca de íons analítica"

Info

Publication number
BRPI1010119A2
BRPI1010119A2 BRPI1010119A BRPI1010119A BRPI1010119A2 BR PI1010119 A2 BRPI1010119 A2 BR PI1010119A2 BR PI1010119 A BRPI1010119 A BR PI1010119A BR PI1010119 A BRPI1010119 A BR PI1010119A BR PI1010119 A2 BRPI1010119 A2 BR PI1010119A2
Authority
BR
Brazil
Prior art keywords
production method
ion exchange
exchange chromatography
antibody composition
composition production
Prior art date
Application number
BRPI1010119A
Other languages
English (en)
Inventor
Bernhard Hilger
Claus Wallerius
Frank Zettl
Josef Burg
Lars Stiens
Thorsten Kaiser
Wolfgang Kuhne
Original Assignee
Hoffmann La Roche
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
Application filed by Hoffmann La Roche filed Critical Hoffmann La Roche
Publication of BRPI1010119A2 publication Critical patent/BRPI1010119A2/pt

Links

Classifications

    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/32Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against translation products of oncogenes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • 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
    • C07K1/16Extraction; Separation; Purification by chromatography
    • C07K1/18Ion-exchange chromatography
    • 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
    • C07K1/16Extraction; Separation; Purification by chromatography
    • C07K1/22Affinity chromatography or related techniques based upon selective absorption processes
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/10Immunoglobulins specific features characterized by their source of isolation or production
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/10Immunoglobulins specific features characterized by their source of isolation or production
    • C07K2317/14Specific host cells or culture conditions, e.g. components, pH or temperature
    • 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)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Immunology (AREA)
  • Analytical Chemistry (AREA)
  • Oncology (AREA)
  • Public Health (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Peptides Or Proteins (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
BRPI1010119A 2009-07-24 2010-07-22 "método de produção de composição de anticorpo e uso de cromatografia de troca de íons analítica" BRPI1010119A2 (pt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP09009640 2009-07-24
PCT/EP2010/004509 WO2011009623A1 (en) 2009-07-24 2010-07-22 Optimizing the production of antibodies

Publications (1)

Publication Number Publication Date
BRPI1010119A2 true BRPI1010119A2 (pt) 2016-03-15

Family

ID=41381958

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI1010119A BRPI1010119A2 (pt) 2009-07-24 2010-07-22 "método de produção de composição de anticorpo e uso de cromatografia de troca de íons analítica"

Country Status (12)

Country Link
US (3) US20120177640A1 (pt)
EP (2) EP3404044A1 (pt)
JP (1) JP5540095B2 (pt)
KR (1) KR101498772B1 (pt)
CN (1) CN102471377B (pt)
AU (1) AU2010275774B2 (pt)
BR (1) BRPI1010119A2 (pt)
CA (1) CA2768325C (pt)
IL (1) IL217381A (pt)
MX (1) MX2012000841A (pt)
SG (1) SG178078A1 (pt)
WO (1) WO2011009623A1 (pt)

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AU2007294731B2 (en) 2006-09-13 2014-04-17 Abbvie Inc. Cell culture improvements
US8911964B2 (en) 2006-09-13 2014-12-16 Abbvie Inc. Fed-batch method of making human anti-TNF-alpha antibody
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
BRPI0920572A8 (pt) 2008-10-20 2015-10-27 Abbott Lab Inativação viral durante a purificação dos anticorpos
KR101574864B1 (ko) 2010-12-21 2015-12-11 에프. 호프만-라 로슈 아게 이소폼이 농축된 항체 제제 및 그의 제조 방법
US9062106B2 (en) 2011-04-27 2015-06-23 Abbvie Inc. Methods for controlling the galactosylation profile of recombinantly-expressed proteins
US20140107321A1 (en) * 2011-05-26 2014-04-17 Dr. Reddy's Laboratories Limited Purification of antibodies
US8852435B2 (en) * 2011-11-29 2014-10-07 Therapeutics Proteins International, LLC Purification and separation treatment assembly (PASTA) for biological products
JP6092892B2 (ja) * 2011-12-15 2017-03-08 プレステージ バイオファーマ プライベート リミテッド 抗体の精製方法
WO2013158279A1 (en) 2012-04-20 2013-10-24 Abbvie Inc. Protein purification methods to reduce acidic species
US9067990B2 (en) 2013-03-14 2015-06-30 Abbvie, Inc. Protein purification using displacement chromatography
WO2013158273A1 (en) 2012-04-20 2013-10-24 Abbvie Inc. Methods to modulate c-terminal lysine variant distribution
WO2013176754A1 (en) 2012-05-24 2013-11-28 Abbvie Inc. Novel purification of antibodies using hydrophobic interaction chromatography
US9512214B2 (en) 2012-09-02 2016-12-06 Abbvie, Inc. Methods to control protein heterogeneity
HK1211981A1 (en) 2012-09-02 2016-06-03 Abbvie Inc. Methods to control protein heterogeneity
CN105051528A (zh) * 2012-11-15 2015-11-11 弗·哈夫曼-拉罗切有限公司 离子强度介导的pH梯度离子交换色谱
CN103217499B (zh) * 2013-01-15 2015-12-02 珠海市丽珠单抗生物技术有限公司 一种测定免疫球蛋白电荷异构体的糖基化和末端修饰情况的方法
HK1207960A1 (en) 2013-03-12 2016-02-19 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
US9499614B2 (en) 2013-03-14 2016-11-22 Abbvie Inc. Methods for modulating protein glycosylation profiles of recombinant protein therapeutics using monosaccharides and oligosaccharides
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
WO2014159579A1 (en) 2013-03-14 2014-10-02 Abbvie Inc. MUTATED ANTI-TNFα ANTIBODIES AND METHODS OF THEIR USE
JP2016513478A (ja) * 2013-03-15 2016-05-16 ジェネンテック, インコーポレイテッド 細胞培養培地及び抗体を産生する方法
AU2014287044B2 (en) * 2013-07-12 2020-02-06 Genentech, Inc. Elucidation of ion exchange chromatography input optimization
US9598667B2 (en) 2013-10-04 2017-03-21 Abbvie Inc. Use of metal ions for modulation of protein glycosylation profiles of recombinant proteins
US8946395B1 (en) 2013-10-18 2015-02-03 Abbvie Inc. Purification of proteins using hydrophobic interaction chromatography
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
CN104628846B (zh) * 2013-11-06 2019-12-06 三生国健药业(上海)股份有限公司 重组蛋白质的纯化方法
US20150139988A1 (en) 2013-11-15 2015-05-21 Abbvie, Inc. Glycoengineered binding protein compositions
WO2015083853A1 (ko) * 2013-12-05 2015-06-11 한화케미칼 주식회사 이성질 항체의 함량 조절을 통한 항체 제조 방법
PL3116891T3 (pl) * 2014-03-10 2020-07-27 Richter Gedeon Nyrt. Oczyszczanie immunoglobuliny z zastosowaniem etapów wstępnego oczyszczania
JP6962819B2 (ja) * 2015-04-10 2021-11-05 アディマブ, エルエルシー 親ホモ二量体抗体種からのヘテロ二量体多重特異性抗体の精製方法
US11020686B2 (en) * 2016-08-16 2021-06-01 Regeneron Pharmaceuticals, Inc. Methods for quantitating individual antibodies from a mixture
WO2019183334A1 (en) 2018-03-21 2019-09-26 Waters Technologies Corporation Non-antibody high-affinity-based sample preparation, sorbents, devices and methods
JP7840636B2 (ja) * 2018-04-02 2026-04-06 アムジェン インコーポレイテッド エレヌマブ組成物及びその使用
CN109293734A (zh) * 2018-09-29 2019-02-01 上海药明生物技术有限公司 一种消除层析中洗脱肩峰的方法
WO2020141117A1 (en) * 2018-12-30 2020-07-09 F. Hoffmann-La Roche Ag Ph-gradient spr-based binding assay
JPWO2024090489A1 (pt) * 2022-10-26 2024-05-02
CN120248116B (zh) * 2024-04-09 2026-02-24 正大天晴药业集团南京顺欣制药有限公司 一种制备贝伐珠单抗的方法

Family Cites Families (9)

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Publication number Priority date Publication date Assignee Title
EP1400536A1 (en) 1991-06-14 2004-03-24 Genentech Inc. Method for making humanized antibodies
IL118201A (en) 1995-05-11 2004-12-15 Roche Diagnostics Gmbh Preparation comprising a protein with human erythropoietin activity which is free of serum and non-recombinant mammalian protein and process for the preparation thereof
DE69738075T2 (de) * 1996-11-27 2008-05-21 Genentech, Inc., South San Francisco Affinitätsreinigung von polypeptiden an einer protein a-matrix
DK1308455T3 (da) 1998-05-06 2006-07-31 Genentech Inc Sammensætning omfattende anti-HER2-antistoffer
NZ507557A (en) 1998-05-06 2003-10-31 Genentech Inc Protein purification by ion exchange chromatography
HUE033623T2 (en) 2002-09-11 2017-12-28 Genentech Inc protein purification
WO2006084111A2 (en) 2005-02-04 2006-08-10 Glaxo Group Limited Optimization of heterologous polypeptide expression
CN102887955A (zh) * 2006-04-05 2013-01-23 艾博特生物技术有限公司 抗体纯化
US9345661B2 (en) * 2009-07-31 2016-05-24 Genentech, Inc. Subcutaneous anti-HER2 antibody formulations and uses thereof

Also Published As

Publication number Publication date
KR101498772B1 (ko) 2015-03-04
SG178078A1 (en) 2012-03-29
AU2010275774A1 (en) 2012-01-12
IL217381A (en) 2016-04-21
KR20120046274A (ko) 2012-05-09
US20190218305A1 (en) 2019-07-18
CN102471377B (zh) 2015-04-22
JP2013500244A (ja) 2013-01-07
EP2456789A1 (en) 2012-05-30
CA2768325C (en) 2019-10-29
US20160102149A1 (en) 2016-04-14
CN102471377A (zh) 2012-05-23
US20120177640A1 (en) 2012-07-12
AU2010275774B2 (en) 2016-03-31
JP5540095B2 (ja) 2014-07-02
MX2012000841A (es) 2012-02-28
IL217381A0 (en) 2012-02-29
EP3404044A1 (en) 2018-11-21
CA2768325A1 (en) 2011-01-27
WO2011009623A1 (en) 2011-01-27

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Legal Events

Date Code Title Description
B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]

Free format text: DE ACORDO COM O ARTIGO 229-C DA LEI NO 10196/2001, QUE MODIFICOU A LEI NO 9279/96, A CONCESSAO DA PATENTE ESTA CONDICIONADA A ANUENCIA PREVIA DA ANVISA. CONSIDERANDO A APROVACAO DOS TERMOS DO PARECER NO 337/PGF/EA/2010, BEM COMO A PORTARIA INTERMINISTERIAL NO 1065 DE 24/05/2012, ENCAMINHA-SE O PRESENTE PEDIDO PARA AS PROVIDENCIAS CABIVEIS.

B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]
B07A Application suspended after technical examination (opinion) [chapter 7.1 patent gazette]
B09B Patent application refused [chapter 9.2 patent gazette]
B09B Patent application refused [chapter 9.2 patent gazette]

Free format text: MANTIDO O INDEFERIMENTO UMA VEZ QUE NAO FOI APRESENTADO RECURSO DENTRO DO PRAZO LEGAL.MANTIDO O INDEFERIMENTO UMA VEZ QUE NAO FOI APRESENTADO RECURSO DENTRO DO PRAZO LEGAL.