WO2004087761A1 - 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 - Google Patents
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 Download PDFInfo
- Publication number
- WO2004087761A1 WO2004087761A1 PCT/JP2004/003425 JP2004003425W WO2004087761A1 WO 2004087761 A1 WO2004087761 A1 WO 2004087761A1 JP 2004003425 W JP2004003425 W JP 2004003425W WO 2004087761 A1 WO2004087761 A1 WO 2004087761A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- antibody
- buffer
- mixture containing
- following
- purifying
- Prior art date
Links
Classifications
-
- 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
- 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
- C07K1/16—Extraction; Separation; Purification by chromatography
- C07K1/18—Ion-exchange chromatography
-
- 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
- C07K1/16—Extraction; Separation; Purification by chromatography
- C07K1/20—Partition-, reverse-phase or hydrophobic interaction chromatography
-
- 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
- C07K1/16—Extraction; Separation; Purification by chromatography
- C07K1/22—Affinity chromatography or related techniques based upon selective absorption processes
-
- 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
- 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
Definitions
- the virus is inactivated by adjusting the eluate obtained in step (3) to pH 4 or lower and leaving it to stand for 30 minutes or more.
- a method for purifying an antibody from a mixture containing the antibody is provided.
- a method for purifying an antibody from a mixture containing the antibody comprising:
- the buffer solution of ⁇ 6.0-8.5 in step (2) described in the above item 48 is the same as the buffer solution of the step (1), and the buffer solution of ⁇ 4.0-7.0 of the step (5) described in the above item 48 is 52.
- one of the steps of inactivating the virus by placing the antibody-containing solution under acidic conditions, removing the virus from the antibody-containing solution using a virus removal filter, and aseptically filtering the antibody-containing solution.
- both the sodium phosphate buffer and the Tris-HC1 buffer may be used, for example, the sodium phosphate buffer and the Tris-HC1 buffer may be added in this order, or the sodium phosphate buffer and the sodium phosphate buffer may be added. Only one of the solution or Tris-HC1 buffer may be used.
- the concentrations of the sodium phosphate and Tris_HCl buffers used are preferably 10 to 200 mM and 0.5 to 1.5 M, respectively, and more preferably 100 mM and 1.0 M.
- the gradient volume at this time is 20 to 40, preferably 30 column volumes.
- the lower limit of the pH in the pH gradient elution is, for example, pH 2.0 to 3.0, and preferably pH 2.5.
- the linear velocity varies depending on the column size, but may be selected in the range of 50 to 150 cm / h. At this time, elution may be performed stepwise at a pH.
- the MabSelect eluate was adjusted to pH 8.0 with 1M Tris-HC1 (pH 9.0), and then equilibrated with lOmM Tris-HC1 buffer (pH 8.0). It was added to iences Q Sepharose XL 7 dragon ID x 15 cm) (linear velocity 300 cm / h). After the addition was completed, 3 column volumes of the equilibration buffer were passed through the column (linear velocity: 300 cm / h). The fraction not adsorbed to the column was pooled as a human monoclonal antibody eluate.
- a hydrophobic chromatography step may be inserted after the purification sequence of Protein in A affinity chromatography-" ⁇ anion exchange chromatography-" ⁇ cation exchange chromatography.
Landscapes
- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Biochemistry (AREA)
- Biophysics (AREA)
- General Health & Medical Sciences (AREA)
- Genetics & Genomics (AREA)
- Life Sciences & Earth Sciences (AREA)
- Molecular Biology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Analytical Chemistry (AREA)
- Immunology (AREA)
- Peptides Or Proteins (AREA)
- Micro-Organisms Or Cultivation Processes Thereof (AREA)
- Solid-Sorbent Or Filter-Aiding Compositions (AREA)
Abstract
Description
Claims
Priority Applications (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2005504152A JPWO2004087761A1 (ja) | 2003-03-31 | 2004-03-15 | 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 |
EP04720750A EP1614693A4 (en) | 2003-03-31 | 2004-03-15 | PURIFICATION OF A HUMAN MONOCLONAL ANTIBODY AND A HUMAN POLYCLONAL ANTIBODY |
US10/551,182 US20060257972A1 (en) | 2003-03-31 | 2004-03-15 | Purification of human monoclonal antibody and human polyclonal antibody |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2003-097407 | 2003-03-31 | ||
JP2003097407 | 2003-03-31 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2004087761A1 true WO2004087761A1 (ja) | 2004-10-14 |
Family
ID=33127551
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/JP2004/003425 WO2004087761A1 (ja) | 2003-03-31 | 2004-03-15 | 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 |
Country Status (4)
Country | Link |
---|---|
US (1) | US20060257972A1 (ja) |
EP (1) | EP1614693A4 (ja) |
JP (1) | JPWO2004087761A1 (ja) |
WO (1) | WO2004087761A1 (ja) |
Cited By (10)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2006096489A2 (en) * | 2005-03-08 | 2006-09-14 | Pharmacia & Upjohn Company Llc | Anti-m-csf antibody compositions having reduced levels of endotoxin |
JP2010510963A (ja) * | 2006-06-14 | 2010-04-08 | グラクソスミスクライン・リミテッド・ライアビリティ・カンパニー | セラミックヒドロキシアパタイトを使用する抗体の精製方法 |
WO2010109920A1 (ja) | 2009-03-27 | 2010-09-30 | 旭化成メディカル株式会社 | 高濃度モノクローナル抗体溶液中のウイルス除去方法 |
WO2012128353A1 (ja) | 2011-03-24 | 2012-09-27 | 株式会社カネカ | タンパク性物質結合性低分子化合物 |
JP2013540787A (ja) * | 2010-11-01 | 2013-11-07 | ディーエスエム アイピー アセッツ ビー.ブイ. | 単一ユニットイオン交換クロマトグラフィー抗体精製 |
JP2014534055A (ja) * | 2011-10-04 | 2014-12-18 | 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 | クロマトグラフィー精製のための方法および装置 |
KR101520753B1 (ko) * | 2012-03-12 | 2015-05-15 | 메르크 파텐트 게엠베하 | 생물약제학적 제제로부터 플로우 쓰루 모드로 단백질 응집물의 제거 |
JP2017507907A (ja) * | 2014-03-10 | 2017-03-23 | リヒター ゲデオン エヌワイアールティー. | プレクリーニング工程を用いた免疫グロブリンの精製 |
WO2018116198A1 (en) | 2016-12-23 | 2018-06-28 | Serum Institute Of India Private Limited | Improved methods for enhancing antibody productivity in mammalian cell culture and minimizing aggregation during downstream, formulation processes and stable antibody formulations obtained thereof |
CN116655726A (zh) * | 2023-07-31 | 2023-08-29 | 上海澳斯康生物制药有限公司 | 基于离子交换层析的抗体纯化方法 |
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GB0304576D0 (en) * | 2003-02-28 | 2003-04-02 | Lonza Biologics Plc | Protein a chromatography |
US20050272917A1 (en) * | 2004-05-14 | 2005-12-08 | Hematech, Llc | Methods for immunoglobulin purification |
US20080248048A1 (en) | 2005-09-30 | 2008-10-09 | Astrazeneca Ab | Interleukin-13 Antibody Composition |
BRPI0716382B8 (pt) * | 2006-08-28 | 2021-05-25 | Ares Trading Sa | método para reduzir o teor de porções de fc livres em um fluido compreendendo uma proteína contendo fc, e uso de cromatografia de troca catiônica |
US8513393B2 (en) * | 2006-08-28 | 2013-08-20 | Ares Trading S.A. | Process for the purification of Fc-containing proteins |
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US20080167450A1 (en) * | 2007-01-05 | 2008-07-10 | Hai Pan | Methods of purifying proteins |
AU2008206923A1 (en) * | 2007-01-17 | 2008-07-24 | Merck Serono S.A. | Process for the purification of Fc-containing proteins |
EP2725035A1 (en) | 2007-10-02 | 2014-04-30 | Avaxia Biologics, Inc. | Antibody therapy for use in the digestive tract |
WO2009058769A1 (en) * | 2007-10-30 | 2009-05-07 | Schering Corporation | Purification of antibodies containing hydrophobic variants |
HUE037409T2 (hu) * | 2007-10-30 | 2018-08-28 | Genentech Inc | Antitest-tisztítás kationcserés kromatográfiával |
CA2738499A1 (en) * | 2008-10-20 | 2010-04-29 | Abbott Laboratories | Viral inactivation during purification of antibodies |
WO2011031397A1 (en) | 2009-08-06 | 2011-03-17 | Genentech, Inc. | Method to improve virus removal in protein purification |
LT2483305T (lt) | 2009-10-01 | 2016-11-25 | F.Hoffmann-La Roche Ag | Daugiakopis galutinis imunoglobulino filtravimas |
WO2011038894A1 (en) | 2009-10-01 | 2011-04-07 | F. Hoffmann-La Roche Ag | Protein a chromatography |
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CA2777978A1 (en) | 2011-05-27 | 2012-11-27 | Abbott Biotherapeutics Corp. | Dac hyp compositions and methods |
US20150232539A1 (en) * | 2012-09-05 | 2015-08-20 | University Of Southern California | Methods and Compositions for Detecting, Imaging, and Treating Small Cell Lung Cancer Utilizing Post-Translationally Modified Residues and Higher Molecular Weight Antigenic Complexes in Proteins |
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KR101838039B1 (ko) * | 2013-03-14 | 2018-03-14 | 이엠디 밀리포어 코포레이션 | 단백질 a 기반 크로마토그래피를 이용한 단백질 순도의 증가 방법 |
JP6472786B2 (ja) * | 2013-03-15 | 2019-02-20 | アルダー・バイオファーマシューティカルズ・インコーポレーテッド | 抗体の精製及び純度のモニタリング |
KR101569783B1 (ko) * | 2013-06-05 | 2015-11-19 | 한화케미칼 주식회사 | 항체의 정제 방법 |
TWI596107B (zh) | 2013-06-25 | 2017-08-21 | 卡地拉保健有限公司 | 單株抗體之新穎純化方法 |
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US10688412B2 (en) | 2016-07-25 | 2020-06-23 | Cehpalon, Inc. | Affinity chromatography wash buffer |
AU2017312785A1 (en) | 2016-08-16 | 2019-01-24 | Regeneron Pharmaceuticals, Inc. | Methods for quantitating individual antibodies from a mixture |
EP4071469A3 (en) | 2016-10-25 | 2022-12-14 | Regeneron Pharmaceuticals, Inc. | Methods and systems for chromatography data analysis |
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BR112020009259A2 (pt) | 2017-11-14 | 2020-10-20 | Bio-Sourcing S.A. | purificação de anticorpo |
EP3769083A1 (en) | 2018-03-21 | 2021-01-27 | Waters Technologies Corporation | Non-antibody high-affinity-based sample preparation, sorbents, devices and methods |
EA202190163A1 (ru) | 2018-07-02 | 2021-03-30 | Ридженерон Фармасьютикалз, Инк. | Системы и способы получения полипептида из смеси |
JP2022542317A (ja) * | 2019-08-01 | 2022-09-30 | 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 | ウイルス不活性化のための方法 |
Citations (4)
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JPH05310780A (ja) * | 1992-04-28 | 1993-11-22 | Toagosei Chem Ind Co Ltd | 抗体の分離精製方法 |
WO1996033208A1 (en) * | 1995-04-20 | 1996-10-24 | Genentech, Inc. | Antibody purification by low-ph hydrophobic interaction chromatoggraphy |
WO1999064462A1 (en) * | 1998-06-09 | 1999-12-16 | Statens Serum Institut | Process for producing immunoglobulins for intravenous administration and other immunoglobulin products |
WO2001064711A1 (fr) * | 2000-03-02 | 2001-09-07 | Kyowa Hakko Kogyo Co., Ltd. | Procede de separation et de purification de proteine |
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-
2004
- 2004-03-15 JP JP2005504152A patent/JPWO2004087761A1/ja not_active Withdrawn
- 2004-03-15 US US10/551,182 patent/US20060257972A1/en not_active Abandoned
- 2004-03-15 EP EP04720750A patent/EP1614693A4/en not_active Withdrawn
- 2004-03-15 WO PCT/JP2004/003425 patent/WO2004087761A1/ja active Application Filing
Patent Citations (4)
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JPH05310780A (ja) * | 1992-04-28 | 1993-11-22 | Toagosei Chem Ind Co Ltd | 抗体の分離精製方法 |
WO1996033208A1 (en) * | 1995-04-20 | 1996-10-24 | Genentech, Inc. | Antibody purification by low-ph hydrophobic interaction chromatoggraphy |
WO1999064462A1 (en) * | 1998-06-09 | 1999-12-16 | Statens Serum Institut | Process for producing immunoglobulins for intravenous administration and other immunoglobulin products |
WO2001064711A1 (fr) * | 2000-03-02 | 2001-09-07 | Kyowa Hakko Kogyo Co., Ltd. | Procede de separation et de purification de proteine |
Non-Patent Citations (3)
Title |
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LEIBL H. AND WALTER ERBER: "Separation of polysaccharide-specific human immunoglobulin G subclasses using a protein a superose column with a pH gradient elution system", JOURNAL OF CHROMATOGRAPHY, vol. 639, no. 1, 4 June 1993 (1993-06-04), pages 51 - 56, XP002980265 * |
MOELLERING B.J. ET AL: "Separating Clinical Grade Chimeric Antibodies from serum-derived immunoglobulins", BIOPHARM, vol. 3, no. 1, 1990, pages 34 - 38, XP002980264 * |
See also references of EP1614693A4 * |
Cited By (15)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2006096489A3 (en) * | 2005-03-08 | 2007-03-22 | Pharmacia & Upjohn Co Llc | Anti-m-csf antibody compositions having reduced levels of endotoxin |
WO2006096489A2 (en) * | 2005-03-08 | 2006-09-14 | Pharmacia & Upjohn Company Llc | Anti-m-csf antibody compositions having reduced levels of endotoxin |
JP2010510963A (ja) * | 2006-06-14 | 2010-04-08 | グラクソスミスクライン・リミテッド・ライアビリティ・カンパニー | セラミックヒドロキシアパタイトを使用する抗体の精製方法 |
WO2010109920A1 (ja) | 2009-03-27 | 2010-09-30 | 旭化成メディカル株式会社 | 高濃度モノクローナル抗体溶液中のウイルス除去方法 |
JP2013540787A (ja) * | 2010-11-01 | 2013-11-07 | ディーエスエム アイピー アセッツ ビー.ブイ. | 単一ユニットイオン交換クロマトグラフィー抗体精製 |
US9273151B2 (en) | 2011-03-24 | 2016-03-01 | Kaneka Corporation | Proteinaceous-substance-binding low-molecular-weight compound |
WO2012128353A1 (ja) | 2011-03-24 | 2012-09-27 | 株式会社カネカ | タンパク性物質結合性低分子化合物 |
JP2014534055A (ja) * | 2011-10-04 | 2014-12-18 | 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 | クロマトグラフィー精製のための方法および装置 |
KR101520753B1 (ko) * | 2012-03-12 | 2015-05-15 | 메르크 파텐트 게엠베하 | 생물약제학적 제제로부터 플로우 쓰루 모드로 단백질 응집물의 제거 |
JP2017507907A (ja) * | 2014-03-10 | 2017-03-23 | リヒター ゲデオン エヌワイアールティー. | プレクリーニング工程を用いた免疫グロブリンの精製 |
KR101921552B1 (ko) * | 2014-03-10 | 2018-11-23 | 리히터 게데온 닐트. | 사전 세정 단계를 이용하는 면역글로불린 정제 |
US10487138B2 (en) | 2014-03-10 | 2019-11-26 | Richter Gedeon Nyrt. | Immunoglobulin purification using pre-cleaning steps |
WO2018116198A1 (en) | 2016-12-23 | 2018-06-28 | Serum Institute Of India Private Limited | Improved methods for enhancing antibody productivity in mammalian cell culture and minimizing aggregation during downstream, formulation processes and stable antibody formulations obtained thereof |
CN116655726A (zh) * | 2023-07-31 | 2023-08-29 | 上海澳斯康生物制药有限公司 | 基于离子交换层析的抗体纯化方法 |
CN116655726B (zh) * | 2023-07-31 | 2023-11-14 | 上海澳斯康生物制药有限公司 | 基于离子交换层析的抗体纯化方法 |
Also Published As
Publication number | Publication date |
---|---|
EP1614693A1 (en) | 2006-01-11 |
US20060257972A1 (en) | 2006-11-16 |
EP1614693A4 (en) | 2006-07-19 |
JPWO2004087761A1 (ja) | 2006-07-27 |
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