DK1888636T4 - Fremgangsmåde til oprensning af antistoffer - Google Patents

Fremgangsmåde til oprensning af antistoffer Download PDF

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Publication number
DK1888636T4
DK1888636T4 DK06753791.0T DK06753791T DK1888636T4 DK 1888636 T4 DK1888636 T4 DK 1888636T4 DK 06753791 T DK06753791 T DK 06753791T DK 1888636 T4 DK1888636 T4 DK 1888636T4
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DK
Denmark
Prior art keywords
purification
ion exchange
antibodies
procedure
immunoglobulin
Prior art date
Application number
DK06753791.0T
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English (en)
Other versions
DK1888636T3 (da
Inventor
Roberto Falkenstein
Burkard Kolb
Maria Smida
Original Assignee
Hoffmann La Roche
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Publication date
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Application filed by Hoffmann La Roche filed Critical Hoffmann La Roche
Publication of DK1888636T3 publication Critical patent/DK1888636T3/da
Application granted granted Critical
Publication of DK1888636T4 publication Critical patent/DK1888636T4/da

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    • 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
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D15/00Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08Selective adsorption, e.g. chromatography
    • B01D15/26Selective adsorption, e.g. chromatography characterised by the separation mechanism
    • B01D15/36Selective adsorption, e.g. chromatography characterised by the separation mechanism involving ionic interaction
    • B01D15/361Ion-exchange
    • B01D15/362Cation-exchange
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D15/00Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08Selective adsorption, e.g. chromatography
    • B01D15/26Selective adsorption, e.g. chromatography characterised by the separation mechanism
    • B01D15/36Selective adsorption, e.g. chromatography characterised by the separation mechanism involving ionic interaction
    • B01D15/361Ion-exchange
    • B01D15/363Anion-exchange
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D15/00Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08Selective adsorption, e.g. chromatography
    • B01D15/42Selective adsorption, e.g. chromatography characterised by the development mode, e.g. by displacement or by elution
    • B01D15/424Elution mode
    • B01D15/426Specific type of solvent
    • 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
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • 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
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2866Immunoglobulins [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 cytokines, lymphokines, interferons
    • 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
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/96Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation using ion-exchange
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments

Landscapes

  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Medicinal Chemistry (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Analytical Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oncology (AREA)
  • Physics & Mathematics (AREA)
  • General Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Peptides Or Proteins (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
DK06753791.0T 2005-05-25 2006-05-23 Fremgangsmåde til oprensning af antistoffer DK1888636T4 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP05011302 2005-05-25
PCT/EP2006/004863 WO2006125599A2 (en) 2005-05-25 2006-05-23 Method for the purification of antibodies

Publications (2)

Publication Number Publication Date
DK1888636T3 DK1888636T3 (da) 2011-11-14
DK1888636T4 true DK1888636T4 (da) 2022-07-18

Family

ID=34936911

Family Applications (1)

Application Number Title Priority Date Filing Date
DK06753791.0T DK1888636T4 (da) 2005-05-25 2006-05-23 Fremgangsmåde til oprensning af antistoffer

Country Status (18)

Country Link
US (3) US20090098660A1 (da)
EP (2) EP2261252B2 (da)
JP (1) JP4852602B2 (da)
KR (1) KR100967778B1 (da)
CN (1) CN101180317B (da)
AT (1) ATE525087T1 (da)
AU (1) AU2006251307B2 (da)
BR (1) BRPI0610201B8 (da)
CA (1) CA2607375C (da)
DK (1) DK1888636T4 (da)
ES (2) ES2389641T5 (da)
FI (1) FI1888636T4 (da)
IL (2) IL186338A (da)
MX (1) MX2007014269A (da)
NO (1) NO345362B1 (da)
PL (1) PL1888636T5 (da)
TW (2) TWI391399B (da)
WO (1) WO2006125599A2 (da)

Families Citing this family (23)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TWI391399B (zh) 2005-05-25 2013-04-01 Hoffmann La Roche 測定溶離多肽之鹽濃度之方法
KR101226353B1 (ko) 2007-06-01 2013-01-24 에프. 호프만-라 로슈 아게 면역글로불린 정제
CL2008002053A1 (es) 2007-07-17 2009-05-22 Hoffmann La Roche Metodo para la purificacion de una eritropoyetina monopeguilada (epompeg) que consiste en proporcionar una solucion que contiene eritropoyetina mono, poli y no peguilada y hacerla pasar por dos pasos de cromatografia de intercambio cationico y metodo para producir epo mpeg que incluye metodo de purificacion.
AR067536A1 (es) 2007-07-17 2009-10-14 Hoffmann La Roche Metodo para obtener una eritropoyetina mono-pegilada en una forma sustancialmente homogenea
SG2013061528A (en) * 2008-08-14 2015-03-30 Merck Sharp & Dohme Methods for purifying antibodies using protein a affinity chromatography
JP5814951B2 (ja) 2010-03-10 2015-11-17 エフ.ホフマン−ラ ロシュ アーゲーF. Hoffmann−La Roche Aktiengesellschaft 免疫グロブリン溶液を精製するための方法
JP5737817B2 (ja) * 2010-04-14 2015-06-17 エフ.ホフマン−ラ ロシュ アーゲーF. Hoffmann−La Roche Aktiengesellschaft 免疫グロブリン凝集体の除去
JP6023715B2 (ja) * 2010-10-11 2016-11-09 アッヴィ・バハマズ・リミテッド タンパク質の精製方法
JP5838221B2 (ja) * 2010-12-21 2016-01-06 エフ・ホフマン−ラ・ロシュ・アクチェンゲゼルシャフト アイソフォーム濃縮抗体調製物及びこれを得る方法
EP2686334B2 (en) 2011-03-16 2020-07-01 F.Hoffmann-La Roche Ag Ion exchange chromatography with improved selectivity for the separation of polypeptide monomers, aggregates and fragments by modulation of the mobile phase
SG10201605397PA (en) 2011-07-01 2016-08-30 Hoffmann La Roche Method For Separation Of Monomeric Polypeptides From Aggregated Polypeptides
US10481164B2 (en) * 2012-03-26 2019-11-19 Amgen Inc. Method for using light scattering in real time to directly monitor and control impurity removal in purification processes
CN105555795A (zh) * 2013-09-17 2016-05-04 株式会社钟化 新抗体纯化方法和由该方法得到的抗体、以及使用了阳离子交换基团的新抗体纯化法和由该方法得到的抗体
WO2015064971A1 (ko) * 2013-10-30 2015-05-07 (주)셀트리온 양이온 교환 크로마토그래피를 이용한 항체의 아형 분리 방법
SI3215528T1 (sl) 2014-11-06 2019-11-29 Hoffmann La Roche Variante regije Fc s spremenjeno vezavo FcRn in postopki uporabe
GB2539420B (en) * 2015-06-16 2021-01-13 Cytiva Sweden Ab Determination of chromatography conditions
CA3005484A1 (en) * 2015-11-18 2017-05-26 Merck Patent Gmbh Opposite ph-salt gradients for improved protein separations
JP2018538268A (ja) * 2015-11-18 2018-12-27 メルク パテント ゲゼルシャフト ミット ベシュレンクテル ハフツングMerck Patent Gesellschaft mit beschraenkter Haftung イオン交換クロマトグラフィーにおける改善されたタンパク質分離
EP3769083A1 (en) 2018-03-21 2021-01-27 Waters Technologies Corporation Non-antibody high-affinity-based sample preparation, sorbents, devices and methods
WO2019192877A1 (en) * 2018-04-03 2019-10-10 Merck Patent Gmbh Cex chromatography media and low salt elution of target proteins from biopharmaceutical feeds
CN111068361B (zh) * 2018-10-22 2022-02-11 中国石油化工股份有限公司 一种己内酰胺离子交换装置及其再生方法
CN110066314B (zh) * 2019-04-01 2023-10-27 上海药明生物技术有限公司 一种高效提高多聚体分离分辨率的亲和纯化工艺
TW202128264A (zh) * 2019-09-25 2021-08-01 瑞士商赫孚孟拉羅股份公司 使用經預測之溶離緩衝鹽濃度的陽離子層析法

Family Cites Families (37)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4136094A (en) * 1977-08-31 1979-01-23 The Regents Of The University Of Minnesota Preparation of intravenous human and animal gamma globulins and isolation of albumin
JPS5598117A (en) 1979-01-17 1980-07-25 Chemo Sero Therapeut Res Inst Purification of gamma-globulin derivative
EP0085747B2 (de) * 1982-02-08 1990-05-30 Schweizerisches Serum- und Impfinstitut und Institut zur Erforschung der Infektionskrankheiten Intravenös verabreichbares humanes Immunglobulin und Verfahren zu dessen Herstellung
JPS6042336A (ja) * 1983-08-18 1985-03-06 Nippon Seiyaku Kk 免疫グロブリンの製造方法
DE3640513A1 (de) 1986-11-27 1988-06-09 Biotest Pharma Gmbh Verfahren zur herstellung eines virussicheren, lagerstabilen und intravenoes vertraeglichen immunglobulin-g-praeparates
US5118796A (en) * 1987-12-09 1992-06-02 Centocor, Incorporated Efficient large-scale purification of immunoglobulins and derivatives
US4983722A (en) 1988-06-08 1991-01-08 Miles Inc. Removal of protein A from antibody preparations
US5177194A (en) 1990-02-01 1993-01-05 Baxter International, Inc. Process for purifying immune serum globulins
ATE122054T1 (de) * 1990-03-22 1995-05-15 Biotest Pharma Gmbh Verfahren zur herstellung eines intravenös verträglichen immunglobulin-g-präparates.
EP0529086B1 (en) * 1991-02-26 1999-05-19 Ajinomoto Co., Inc. Process for purifying human bcdf
AP257A (en) 1991-04-26 1993-06-03 Surface Active Ltd A method of releasing an antigen from an antibody and methods for their use in diagnosis and therapy.
DE4118912C1 (da) 1991-06-08 1992-07-02 Biotest Pharma Gmbh, 6072 Dreieich, De
CA2113813C (en) 1991-08-14 2005-04-12 Paula M. Jardieu Immunoglobulin variants for specific fc epsilon receptors
BR9305557A (pt) 1992-06-26 1997-03-25 Aetsrn Anticorpos monoclonais humanos anti Rhesus-D e composiçao farmacêutica que os contém
FR2706466B1 (fr) * 1993-06-14 1995-08-25 Aetsrn Concentré d'immunoglobulines G à usage thérapeutique et procédé de production dudit concentré.
IT1271461B (it) 1993-12-01 1997-05-28 Menarini Ricerche Sud Spa Anticorpo monoclonale bispecifico anti-cd3/anti-egfr,processo per la produzione e suo uso.
DK0659767T4 (da) 1993-12-27 2003-02-10 Zlb Bioplasma Ag Fremgangsmåde til fremstilling af et koncentrat af anti-D-immunoglobulin G og et farmaceutisk præparat, som indeholder dette
US5429746A (en) 1994-02-22 1995-07-04 Smith Kline Beecham Corporation Antibody purification
FI952196A0 (fi) * 1995-05-08 1995-05-08 Suomen Punainen Risti Veripalv Framstaellning av immunoglobulin
IL121900A (en) 1997-10-07 2001-12-23 Omrix Biopharmaceuticals Ltd A method for the purification of immunoglobulins
US6162904A (en) * 1997-12-24 2000-12-19 Alpha Therapeutic Corporation Manufacturing method for intraveneously administrable immune globulin and resultant product
UA64742C2 (uk) 1997-12-24 2004-03-15 Альфа Терапевтик Корпорейшн СПОСІБ ОДЕРЖАННЯ РОЗЧИНУ <font face="Symbol">g</font>-ГЛОБУЛІНУ, ПРИЗНАЧЕНОГО ДЛЯ ВНУТРІШНЬОВЕННОГО ВВЕДЕННЯ, І ПРОДУКТ, ЩО ОДЕРЖУЄТЬСЯ У ЦЕЙ СПОСІБ (ВАРІАНТИ)
DE69936946T2 (de) * 1998-05-06 2008-05-15 Genentech, Inc., South San Francisco Reinigung von Antikörpern durch Ionenaustauschchromatographie
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
JP4685238B2 (ja) * 1998-06-09 2011-05-18 ツエー・エス・エル・ベーリング・アクチエンゲゼルシヤフト 静脈投与用免疫グロブリン及び他の免疫グロブリン生成物の製造法
SK288128B6 (sk) 1998-06-09 2013-10-02 Csl Behring Ag Process for purifying immunoglobulin G (IgG), liquid immunoglobulin product and use thereof for the preparation of a medicament
US6441144B1 (en) * 1999-05-20 2002-08-27 Alpha Therapeutic Corporation Method for repairing dual virally inactivated immune globulin for intravenous administration
WO2001072644A1 (en) 2000-03-29 2001-10-04 Ecokasa Incorporated Nitrogen reduction wastewater treatment system
SE0001128D0 (sv) 2000-03-30 2000-03-30 Amersham Pharm Biotech Ab A method of producing IgG
US6962700B1 (en) * 2000-09-13 2005-11-08 Atopix Pharmaceuticals Corporation Method of manufacturing immune globulin
US7323553B2 (en) * 2002-04-26 2008-01-29 Genentech, Inc. Non-affinity purification of proteins
US20050276812A1 (en) * 2004-06-01 2005-12-15 Genentech, Inc. Antibody-drug conjugates and methods
HUE033623T2 (en) 2002-09-11 2017-12-28 Genentech Inc protein purification
CN1490334A (zh) * 2002-10-18 2004-04-21 缪金明 基因特异性抗体的亲和纯化方法
DK1601697T3 (da) 2003-02-28 2007-10-01 Lonza Biologics Plc Oprensning af antistof ved protein A- og ionbytningskromatografi
AR045614A1 (es) 2003-09-10 2005-11-02 Hoffmann La Roche Anticuerpos contra el recepctor de la interleuquina- 1 y los usos de los mismos
TWI391399B (zh) 2005-05-25 2013-04-01 Hoffmann La Roche 測定溶離多肽之鹽濃度之方法

Also Published As

Publication number Publication date
EP1888636B2 (en) 2022-03-30
ES2373402T5 (es) 2022-09-14
US20170183394A1 (en) 2017-06-29
MX2007014269A (es) 2008-01-24
NO345362B1 (no) 2020-12-28
DK1888636T3 (da) 2011-11-14
US11034754B2 (en) 2021-06-15
KR20080017322A (ko) 2008-02-26
JP2008542218A (ja) 2008-11-27
JP4852602B2 (ja) 2012-01-11
ATE525087T1 (de) 2011-10-15
EP2261252A2 (en) 2010-12-15
TWI391399B (zh) 2013-04-01
BRPI0610201B1 (pt) 2020-12-29
FI1888636T4 (fi) 2023-01-31
BRPI0610201B8 (pt) 2021-05-25
EP1888636A2 (en) 2008-02-20
US9631007B2 (en) 2017-04-25
BRPI0610201A2 (pt) 2010-06-01
PL1888636T3 (pl) 2012-02-29
PL1888636T5 (pl) 2023-03-06
ES2389641T5 (es) 2021-06-10
TWI320788B (en) 2010-02-21
CN101180317A (zh) 2008-05-14
WO2006125599A3 (en) 2007-06-21
CA2607375A1 (en) 2006-11-30
KR100967778B1 (ko) 2010-07-05
ES2373402T3 (es) 2012-02-03
CA2607375C (en) 2014-01-21
AU2006251307A1 (en) 2006-11-30
IL186338A (en) 2011-01-31
TW200716669A (en) 2007-05-01
IL206993A0 (en) 2012-01-01
US20140243508A1 (en) 2014-08-28
EP2261252A3 (en) 2011-03-23
IL186338A0 (en) 2008-01-20
EP2261252B2 (en) 2020-10-21
US20090098660A1 (en) 2009-04-16
NO20075091L (no) 2008-01-23
CN101180317B (zh) 2013-06-19
CA2607375F (en) 2006-11-30
AU2006251307B2 (en) 2011-08-04
EP1888636B1 (en) 2011-09-21
WO2006125599A2 (en) 2006-11-30
EP2261252B1 (en) 2012-07-25
ES2389641T3 (es) 2012-10-30
TW200946543A (en) 2009-11-16

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