CN105358572A - 用于纯化抗体的连续多步骤方法 - Google Patents

用于纯化抗体的连续多步骤方法 Download PDF

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Publication number
CN105358572A
CN105358572A CN201480038360.9A CN201480038360A CN105358572A CN 105358572 A CN105358572 A CN 105358572A CN 201480038360 A CN201480038360 A CN 201480038360A CN 105358572 A CN105358572 A CN 105358572A
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China
Prior art keywords
chromatography
protein
passing
buffer
column
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Pending
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CN201480038360.9A
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English (en)
Chinese (zh)
Inventor
D·杜斯
C·赫梅特
L·兰德里克-伯廷
B·莫茨
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Sanofi Aventis France
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Sanofi Aventis France
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Priority to CN202310118200.6A priority Critical patent/CN116003579A/zh
Publication of CN105358572A publication Critical patent/CN105358572A/zh
Pending legal-status Critical Current

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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/06—Immunoglobulins [IG], 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
    • 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 [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/06—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies from serum
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/40—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against enzymes
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
    • C12M47/00—Means for after-treatment of the produced biomass or of the fermentation or metabolic products, e.g. storage of biomass
    • C12M47/12—Purification

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  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Biochemistry (AREA)
  • Genetics & Genomics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Medicinal Chemistry (AREA)
  • Biophysics (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • Analytical Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Biotechnology (AREA)
  • Sustainable Development (AREA)
  • Biomedical Technology (AREA)
  • Microbiology (AREA)
  • General Engineering & Computer Science (AREA)
  • Peptides Or Proteins (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Oncology (AREA)
  • Cell Biology (AREA)
  • Water Supply & Treatment (AREA)
  • Treatment Of Liquids With Adsorbents In General (AREA)
CN201480038360.9A 2013-05-06 2014-05-06 用于纯化抗体的连续多步骤方法 Pending CN105358572A (zh)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN202310118200.6A CN116003579A (zh) 2013-05-06 2014-05-06 用于纯化抗体的连续多步骤方法

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP13305593 2013-05-06
EP13305593.9 2013-05-06
PCT/EP2014/059246 WO2014180852A1 (en) 2013-05-06 2014-05-06 Continuous multistep process for purifying antibodies

Related Child Applications (1)

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CN202310118200.6A Division CN116003579A (zh) 2013-05-06 2014-05-06 用于纯化抗体的连续多步骤方法

Publications (1)

Publication Number Publication Date
CN105358572A true CN105358572A (zh) 2016-02-24

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CN201480038360.9A Pending CN105358572A (zh) 2013-05-06 2014-05-06 用于纯化抗体的连续多步骤方法
CN202310118200.6A Pending CN116003579A (zh) 2013-05-06 2014-05-06 用于纯化抗体的连续多步骤方法

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Country Status (19)

Country Link
US (1) US10793622B2 (2)
EP (2) EP2994485B1 (2)
JP (2) JP6463734B2 (2)
KR (1) KR102272851B1 (2)
CN (2) CN105358572A (2)
AU (1) AU2014264697B2 (2)
BR (1) BR112015027812B1 (2)
CA (1) CA2911462C (2)
CY (1) CY1125281T1 (2)
DK (2) DK3301115T3 (2)
ES (2) ES2905675T3 (2)
HU (2) HUE057119T2 (2)
IL (1) IL242408B (2)
MX (1) MX368177B (2)
NO (1) NO2994485T3 (2)
RU (1) RU2662668C2 (2)
SG (1) SG11201508968XA (2)
TW (2) TWI675041B (2)
WO (1) WO2014180852A1 (2)

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110945008A (zh) * 2017-07-17 2020-03-31 Ucb生物制药有限责任公司 层析
WO2020258704A1 (zh) * 2019-06-28 2020-12-30 信达生物制药(苏州)有限公司 无缝连续流层析方法
CN112189015A (zh) * 2018-03-27 2021-01-05 赛诺菲 用于纯化重组蛋白的完全流穿过程
CN112204127A (zh) * 2018-06-01 2021-01-08 龙沙有限公司 用于有机生长和分阶段的中等规模模型
CN112805293A (zh) * 2018-10-08 2021-05-14 埃博灵克斯股份有限公司 免去层析的抗体纯化方法
CN113825840A (zh) * 2019-04-03 2021-12-21 建新公司 重组蛋白的连续生产

Families Citing this family (30)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9458450B2 (en) 2012-03-15 2016-10-04 Flodesign Sonics, Inc. Acoustophoretic separation technology using multi-dimensional standing waves
US9950282B2 (en) 2012-03-15 2018-04-24 Flodesign Sonics, Inc. Electronic configuration and control for acoustic standing wave generation
US10704021B2 (en) 2012-03-15 2020-07-07 Flodesign Sonics, Inc. Acoustic perfusion devices
US10967298B2 (en) 2012-03-15 2021-04-06 Flodesign Sonics, Inc. Driver and control for variable impedence load
US20150275195A1 (en) * 2012-10-24 2015-10-01 Genzyme Corporation Elution of biomolecules from multi-modal resins using mes and mops as mobile phase modifiers
JPWO2015041218A1 (ja) * 2013-09-17 2017-03-02 株式会社カネカ 新規抗体精製方法及びそれから得られる抗体（ＮｏｖｅｌＡｎｔｉｂｏｄｙＰｕｒｉｆｉｃａｔｉｏｎＭｅｔｈｏｄａｎｄＡｎｔｉｂｏｄｙｏｂｔａｉｎｅｄｔｈｅｒｅｆｒｏｍ）、並びに陽イオン交換基を用いた新規抗体精製法及びそれから得られる抗体（ＮｏｖｅｌＡｎｔｉｂｏｄｙＰｕｒｉｆｉｃａｔｉｏｎｍｅｔｈｏｄｕｓｉｎｇＣａｔｉｏｎＥｘｃｈａｎｇｅｒａｎｄＡｎｔｉｂｏｄｙｏｂｔａｉｎｅｄｔｈｅｒｅｆｒｏｍ）
WO2015105955A1 (en) 2014-01-08 2015-07-16 Flodesign Sonics, Inc. Acoustophoresis device with dual acoustophoretic chamber
GB201503578D0 (en) * 2015-03-03 2015-04-15 Ge Healthcare Bio Sciences Ab Sanitization method for affinity chromatography matrices
US11708572B2 (en) 2015-04-29 2023-07-25 Flodesign Sonics, Inc. Acoustic cell separation techniques and processes
US11021699B2 (en) 2015-04-29 2021-06-01 FioDesign Sonics, Inc. Separation using angled acoustic waves
US11377651B2 (en) 2016-10-19 2022-07-05 Flodesign Sonics, Inc. Cell therapy processes utilizing acoustophoresis
EP3015542A1 (de) * 2015-05-07 2016-05-04 Bayer Technology Services GmbH Modulare anlage und verfahren zur kontinuierlichen, keimreduzierten produktion und/oder aufbereitung eines produktes
US11459540B2 (en) 2015-07-28 2022-10-04 Flodesign Sonics, Inc. Expanded bed affinity selection
US11474085B2 (en) 2015-07-28 2022-10-18 Flodesign Sonics, Inc. Expanded bed affinity selection
US20170101437A1 (en) * 2015-10-09 2017-04-13 Hetero Drugs Ltd. Process for purification of darbepoetin alfa
US11214789B2 (en) 2016-05-03 2022-01-04 Flodesign Sonics, Inc. Concentration and washing of particles with acoustics
US11085035B2 (en) 2016-05-03 2021-08-10 Flodesign Sonics, Inc. Therapeutic cell washing, concentration, and separation utilizing acoustophoresis
WO2018051348A1 (en) * 2016-09-14 2018-03-22 Insight Biopharmaceutical Ltd. Methods of purifying and qualifying antibodies
CA3041517A1 (en) 2016-10-19 2018-04-26 Flodesign Sonics, Inc. Affinity cell extraction by acoustics
CA3057286A1 (en) * 2017-03-24 2018-09-27 Council Of Scientific And Industrial Research A process for the purification of recombinant antibody fragments
US11584777B2 (en) 2017-08-31 2023-02-21 Green Cross Corporation Method for purifying a sulfatase protein
WO2019118921A1 (en) 2017-12-14 2019-06-20 Flodesign Sonics, Inc. Acoustic transducer drive and controller
CN111902720B (zh) 2018-03-21 2025-02-07 沃特世科技公司 基于非抗体高亲和力的样品制备、吸附剂、装置和方法
KR102337683B1 (ko) 2018-09-21 2021-12-13 주식회사 녹십자 고효율 항-tfpi 항체 조성물
WO2020084503A1 (en) * 2018-10-26 2020-04-30 Cadila Healthcare Limited A composition comprising antibody with reduced level of basic variants thereof
WO2020183332A1 (en) * 2019-03-11 2020-09-17 Intas Pharmaceuticals Ltd. Purification of adalimumab using tandem chromatography
JP2023500775A (ja) * 2019-09-23 2023-01-11 メルク・シャープ・アンド・ドーム・エルエルシー 宿主細胞タンパク質が減少し、ポリソルベート－８０安定性が増加した、抗ｃｔｌａ４モノクローナル抗体を含む方法および組成物
KR102154952B1 (ko) * 2020-02-21 2020-09-10 프레스티지바이오로직스 주식회사 아달리무맙의 Non-Protein A 정제방법
CN112574321B (zh) * 2020-12-30 2023-10-20 上海赛金生物医药有限公司 一种捕获单克隆抗体-肿瘤坏死因子融合蛋白的亲和纯化方法
WO2022234412A1 (en) 2021-05-03 2022-11-10 Lupin Limited A process for purification of fc-fusion proteins

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1504482A (zh) * 2002-12-03 2004-06-16 北京优力凯生物技术有限责任公司 无细胞百日咳抗原蛋白的分离纯化方法
CN101981056A (zh) * 2008-01-30 2011-02-23 健泰科生物技术公司 包含结合her2结构域ii的抗体及其酸性变体的组合物
CN102099369A (zh) * 2008-07-18 2011-06-15 泰勒克里斯生物治疗学公司 制备α-1蛋白酶抑制剂的方法
WO2011090719A2 (en) * 2009-12-29 2011-07-28 Dr. Reddy's Laboratories Ltd. Protein purification by ion exchange
CN102239177A (zh) * 2008-02-29 2011-11-09 比奥根艾迪克Ma公司 纯化的免疫球蛋白融合蛋白及其纯化方法
CN102574911A (zh) * 2009-08-07 2012-07-11 米利波尔公司 从样品的一或多种杂质中纯化靶蛋白的方法
WO2012135415A1 (en) * 2011-03-29 2012-10-04 Glaxosmithkline Llc Buffer system for protein purification
WO2013075849A1 (en) * 2011-11-23 2013-05-30 Sanofi Protein purification using bis-tris buffer

Family Cites Families (27)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0313343B2 (en) 1987-10-23 2003-07-23 Schering Corporation Method of purifying protein
DK0668877T3 (da) * 1993-09-21 1999-09-13 Hemosol Inc Fortrængningschromatografisk fremgangsmåde og oprenset hæmoglobinprodukt
CA2106612C (en) 1993-09-21 2001-02-06 Diana Pliura Displacement chromatography process
US5891741A (en) 1997-05-16 1999-04-06 Coulter International Corp. Antibody-aminodextran-phycobiliprotein conjugates
CN1136317C (zh) 1999-03-12 2004-01-28 中国人民解放军第四军医大学 单克隆抗体双段和单段的制备方法
US20020009445A1 (en) 2000-07-12 2002-01-24 Yansheng Du Human beta-amyloid antibody and use thereof for treatment of alzheimer's disease
US6602855B2 (en) 2001-04-30 2003-08-05 Syn X Pharma, Inc. Biopolymer marker indicative of disease state having a molecular weight of 1449 daltons
AU2005236068C1 (en) 2004-04-21 2012-08-30 Beth Israel Deaconess Medical Center, Inc. Poly-N-acetyl glucosamine (PNAG/DPNAG)-binding peptides and methods of use thereof
KR101243601B1 (ko) * 2004-10-21 2013-03-20 지이 헬스케어 바이오-사이언시스 에이비 크로마토그래피 리간드
EP2567976B1 (en) 2005-03-23 2017-07-19 Genmab A/S Antibodies against CD38 for treatment of multiple myeloma
CN1814775A (zh) 2005-12-06 2006-08-09 中国海洋大学 一种抗病毒活性寡聚肽的制备方法
EP1914242A1 (en) * 2006-10-19 2008-04-23 Sanofi-Aventis Novel anti-CD38 antibodies for the treatment of cancer
US8399620B2 (en) * 2007-07-11 2013-03-19 Novo Nordisk A/S Purification of factor VIII using a mixed-mode or multimodal resin
DK2207568T3 (en) 2007-11-16 2017-09-18 Univ Rockefeller ANTIBODIES SPECIFIC TO THE PROTOFIBRILE FORM OF BETA AMYLOID PROTEIN
EP2281000A2 (en) * 2008-05-15 2011-02-09 Novo Nordisk A/S Antibody purification process
JPWO2010071208A1 (ja) 2008-12-19 2012-05-31 武田薬品工業株式会社 抗体の精製方法
US20120022239A1 (en) 2009-01-13 2012-01-26 Ge Healthcare Bio-Sciences Ab Precipitation of biomolecules with negatively charged polymers
KR101224468B1 (ko) * 2009-05-20 2013-01-23 주식회사 파멥신 신규한 형태의 이중표적항체 및 그 용도
JP5787891B2 (ja) * 2009-09-01 2015-09-30 ジェネンテック， インコーポレイテッド 改変されたプロテインａ溶離による向上したタンパク質精製
US9527010B2 (en) * 2009-09-25 2016-12-27 Ge Healthcare Bio-Sciences Corp. Separation system and method
US20120208986A1 (en) * 2009-10-20 2012-08-16 Wenger Marc D Use of mixed mode chromatography for the capture and purification of basic antibody products
EP2415779B1 (en) 2010-08-02 2015-01-21 ratiopharm GmbH Method of producing and purifying an active soluble sialyltransferase
US20120238730A1 (en) * 2011-03-15 2012-09-20 Abbott Laboratories Integrated approach to the isolation and purification of antibodies
WO2012174535A1 (en) 2011-06-17 2012-12-20 Constitution Medical, Inc. Solutions for histoprocessing of biological samples
US9096648B2 (en) 2011-08-19 2015-08-04 Emd Millipore Corporation Methods of reducing level of one or more impurities in a sample during protein purification
EP2578286A1 (en) * 2011-10-04 2013-04-10 Merck Patent GmbH Method and apparatus for chromatographic purification
SG10201604104PA (en) * 2011-10-25 2016-07-28 Prothena Therapeutics Ltd Antibody formulations and methods

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1504482A (zh) * 2002-12-03 2004-06-16 北京优力凯生物技术有限责任公司 无细胞百日咳抗原蛋白的分离纯化方法
CN101981056A (zh) * 2008-01-30 2011-02-23 健泰科生物技术公司 包含结合her2结构域ii的抗体及其酸性变体的组合物
CN102239177A (zh) * 2008-02-29 2011-11-09 比奥根艾迪克Ma公司 纯化的免疫球蛋白融合蛋白及其纯化方法
CN102099369A (zh) * 2008-07-18 2011-06-15 泰勒克里斯生物治疗学公司 制备α-1蛋白酶抑制剂的方法
CN102574911A (zh) * 2009-08-07 2012-07-11 米利波尔公司 从样品的一或多种杂质中纯化靶蛋白的方法
WO2011090719A2 (en) * 2009-12-29 2011-07-28 Dr. Reddy's Laboratories Ltd. Protein purification by ion exchange
WO2012135415A1 (en) * 2011-03-29 2012-10-04 Glaxosmithkline Llc Buffer system for protein purification
WO2013075849A1 (en) * 2011-11-23 2013-05-30 Sanofi Protein purification using bis-tris buffer

Cited By (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110945008A (zh) * 2017-07-17 2020-03-31 Ucb生物制药有限责任公司 层析
CN112189015A (zh) * 2018-03-27 2021-01-05 赛诺菲 用于纯化重组蛋白的完全流穿过程
CN112189015B (zh) * 2018-03-27 2025-05-02 赛诺菲 用于纯化重组蛋白的完全流穿过程
US12391728B2 (en) 2018-03-27 2025-08-19 Sanofi Full flow-through process for purifying recombinant proteins
CN112204127A (zh) * 2018-06-01 2021-01-08 龙沙有限公司 用于有机生长和分阶段的中等规模模型
CN112805293A (zh) * 2018-10-08 2021-05-14 埃博灵克斯股份有限公司 免去层析的抗体纯化方法
US12479885B2 (en) 2018-10-08 2025-11-25 Ablynx N.V. Chromatography-free antibody purification method
CN113825840A (zh) * 2019-04-03 2021-12-21 建新公司 重组蛋白的连续生产
WO2020258704A1 (zh) * 2019-06-28 2020-12-30 信达生物制药(苏州)有限公司 无缝连续流层析方法
CN114026108A (zh) * 2019-06-28 2022-02-08 信达生物制药(苏州)有限公司 无缝连续流层析方法
CN114026108B (zh) * 2019-06-28 2024-09-10 夏尔巴生物技术(苏州)有限公司 无缝连续流层析方法

Also Published As

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CA2911462A1 (en) 2014-11-13
SG11201508968XA (en) 2015-11-27
BR112015027812B1 (pt) 2021-03-30
JP2019104735A (ja) 2019-06-27
TWI631132B (zh) 2018-08-01
RU2662668C2 (ru) 2018-07-26
JP2016519137A (ja) 2016-06-30
JP6463734B2 (ja) 2019-02-06
EP2994485A1 (en) 2016-03-16
HUE057119T2 (hu) 2022-04-28
AU2014264697A1 (en) 2015-11-26
DK3301115T3 (da) 2022-01-31
EP3301115A1 (en) 2018-04-04
TW201908331A (zh) 2019-03-01
EP2994485B1 (en) 2018-01-10
CA2911462C (en) 2021-04-06
DK2994485T3 (en) 2018-04-23
ES2905675T3 (es) 2022-04-11
NO2994485T3 (2) 2018-06-09
AU2014264697B2 (en) 2019-08-22
MX2015015482A (es) 2016-03-21
RU2015151869A (ru) 2017-06-13
US10793622B2 (en) 2020-10-06
TWI675041B (zh) 2019-10-21
EP3301115B1 (en) 2021-11-10
TW201522363A (zh) 2015-06-16
BR112015027812A2 (pt) 2017-07-25
HUE038741T2 (hu) 2018-11-28
ES2665645T3 (es) 2018-04-26
WO2014180852A1 (en) 2014-11-13
MX368177B (es) 2019-09-23
KR20160005047A (ko) 2016-01-13
KR102272851B1 (ko) 2021-07-02
CN116003579A (zh) 2023-04-25
CY1125281T1 (el) 2023-06-09
IL242408B (en) 2020-04-30
US20160083454A1 (en) 2016-03-24

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