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 |
---|---|---|---|
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 |
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 |
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 |
JP2008500972A (ja) * | 2004-05-14 | 2008-01-17 | キリンファーマ株式会社 | 免疫グロブリンの精製方法 |
KR101363777B1 (ko) | 2005-09-30 | 2014-02-14 | 메디뮨 리미티드 | 인터루킨―13 항체 조성물 |
WO2008025747A1 (en) * | 2006-08-28 | 2008-03-06 | Ares Trading S.A. | Process for the purification of fc-fusion proteins |
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 |
US20080167450A1 (en) * | 2007-01-05 | 2008-07-10 | Hai Pan | Methods of purifying proteins |
JP2010516651A (ja) | 2007-01-17 | 2010-05-20 | メルク セローノ ソシエテ アノニム | Fc含有タンパク質の精製のための方法 |
WO2009046168A1 (en) | 2007-10-02 | 2009-04-09 | Avaxia Biologics, Inc. | Antibody therapy for use in the digestive tract |
RS53850B2 (sr) * | 2007-10-30 | 2018-07-31 | Genentech Inc | Pročišćavanje antitela hromatografijom izmene katjona |
WO2009058769A1 (en) * | 2007-10-30 | 2009-05-07 | Schering Corporation | Purification of antibodies containing hydrophobic variants |
JP5856845B2 (ja) * | 2008-10-20 | 2016-02-10 | アッヴィ・インコーポレイテッド | 抗体精製中におけるウイルスの不活性化 |
MX346115B (es) | 2009-08-06 | 2017-03-08 | Genentech Inc * | Metodo para mejorar la eliminación de virus en la purificacion proteica. |
WO2011038894A1 (en) | 2009-10-01 | 2011-04-07 | F. Hoffmann-La Roche Ag | Protein a chromatography |
HUE030186T2 (en) | 2009-10-01 | 2017-04-28 | Hoffmann La Roche | Multiple-step final screening for immunoglobulin |
WO2011090719A2 (en) * | 2009-12-29 | 2011-07-28 | Dr. Reddy's Laboratories Ltd. | Protein purification by ion exchange |
KR20120118065A (ko) * | 2010-02-12 | 2012-10-25 | 디에스엠 아이피 어셋츠 비.브이. | 단일 단위체 항체 정제 |
JP5873016B2 (ja) * | 2010-06-21 | 2016-03-01 | 協和発酵キリン株式会社 | アミノ酸を利用したタンパク質の精製方法 |
SG185920A1 (en) * | 2011-05-27 | 2012-12-28 | Abbott Biotherapeutics Corp | Dac hyp compositions and methods |
WO2014039733A1 (en) * | 2012-09-05 | 2014-03-13 | 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 |
WO2014102814A1 (en) * | 2012-12-31 | 2014-07-03 | Intas Biopharmaceuticals Limited | Process for the purification of fc fusion proteins |
WO2014159064A1 (en) * | 2013-03-14 | 2014-10-02 | Emd Millipore Corporation | Methods of increasing protein purity using protein a based chromatography |
US9518082B2 (en) * | 2013-03-15 | 2016-12-13 | Alderbio Holdings Llc | Antibody purification and purity monitoring |
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 |
GB201506868D0 (en) * | 2015-04-22 | 2015-06-03 | Ucb Biopharma Sprl | Method for protein purification |
US11186858B1 (en) | 2016-03-15 | 2021-11-30 | Fresenius Kabi Deutschland Gmbh | Methods for increasing biosimilarity |
EP3487868A4 (en) | 2016-07-25 | 2020-07-29 | Cephalon, Inc. | WASHING PAD FOR AFFINITY CHROMATOGRAPHY |
KR102369014B1 (ko) | 2016-08-16 | 2022-03-02 | 리제너론 파아마슈티컬스, 인크. | 혼합물로부터 개별 항체들을 정량하는 방법 |
PL3532838T3 (pl) | 2016-10-25 | 2022-10-03 | Regeneron Pharmaceuticals, Inc. | Metody i systemy analizy danych chromatograficznych |
CN111344301A (zh) * | 2017-11-14 | 2020-06-26 | 生物资源公司 | 抗体纯化 |
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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 WO PCT/JP2004/003425 patent/WO2004087761A1/ja active Application Filing
- 2004-03-15 EP EP04720750A patent/EP1614693A4/en not_active Withdrawn
- 2004-03-15 US US10/551,182 patent/US20060257972A1/en not_active Abandoned
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 |
JPWO2004087761A1 (ja) | 2006-07-27 |
EP1614693A4 (en) | 2006-07-19 |
US20060257972A1 (en) | 2006-11-16 |
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