TWI675041B - 用於純化抗體之連續多步驟方法 - Google Patents

用於純化抗體之連續多步驟方法 Download PDF

Info

Publication number
TWI675041B
TWI675041B TW107117528A TW107117528A TWI675041B TW I675041 B TWI675041 B TW I675041B TW 107117528 A TW107117528 A TW 107117528A TW 107117528 A TW107117528 A TW 107117528A TW I675041 B TWI675041 B TW I675041B
Authority
TW
Taiwan
Prior art keywords
chromatography
buffer
protein
chromatography column
passing
Prior art date
Application number
TW107117528A
Other languages
English (en)
Chinese (zh)
Other versions
TW201908331A (zh
Inventor
多斯迪德
海默席琳
藍瑞克-伯丁羅瑞
莫斯班歐特
Original Assignee
法商賽諾菲公司
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 法商賽諾菲公司 filed Critical 法商賽諾菲公司
Publication of TW201908331A publication Critical patent/TW201908331A/zh
Application granted granted Critical
Publication of TWI675041B publication Critical patent/TWI675041B/zh

Links

Classifications

    • 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
    • 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
    • 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
    • C07K1/36Extraction; Separation; Purification by a combination of two or more processes of different types
    • 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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/40Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against enzymes
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12MAPPARATUS 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
    • C12M47/00Means for after-treatment of the produced biomass or of the fermentation or metabolic products, e.g. storage of biomass
    • C12M47/12Purification

Landscapes

  • 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)
  • Biophysics (AREA)
  • Medicinal Chemistry (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • Analytical Chemistry (AREA)
  • Biotechnology (AREA)
  • Wood Science & Technology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Zoology (AREA)
  • General Engineering & Computer Science (AREA)
  • Sustainable Development (AREA)
  • Microbiology (AREA)
  • Biomedical Technology (AREA)
  • Peptides Or Proteins (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Water Supply & Treatment (AREA)
  • Oncology (AREA)
  • Cell Biology (AREA)
  • Treatment Of Liquids With Adsorbents In General (AREA)
TW107117528A 2013-05-06 2014-05-06 用於純化抗體之連續多步驟方法 TWI675041B (zh)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP13305593 2013-05-06
??13305593.9 2013-05-06

Publications (2)

Publication Number Publication Date
TW201908331A TW201908331A (zh) 2019-03-01
TWI675041B true TWI675041B (zh) 2019-10-21

Family

ID=48430636

Family Applications (2)

Application Number Title Priority Date Filing Date
TW107117528A TWI675041B (zh) 2013-05-06 2014-05-06 用於純化抗體之連續多步驟方法
TW103116153A TWI631132B (zh) 2013-05-06 2014-05-06 用於純化抗體之連續多步驟方法

Family Applications After (1)

Application Number Title Priority Date Filing Date
TW103116153A TWI631132B (zh) 2013-05-06 2014-05-06 用於純化抗體之連續多步驟方法

Country Status (19)

Country Link
US (1) US10793622B2 (enExample)
EP (2) EP2994485B1 (enExample)
JP (2) JP6463734B2 (enExample)
KR (1) KR102272851B1 (enExample)
CN (2) CN116003579A (enExample)
AU (1) AU2014264697B2 (enExample)
BR (1) BR112015027812B1 (enExample)
CA (1) CA2911462C (enExample)
CY (1) CY1125281T1 (enExample)
DK (2) DK2994485T3 (enExample)
ES (2) ES2665645T3 (enExample)
HU (2) HUE057119T2 (enExample)
IL (1) IL242408B (enExample)
MX (1) MX368177B (enExample)
NO (1) NO2994485T3 (enExample)
RU (1) RU2662668C2 (enExample)
SG (1) SG11201508968XA (enExample)
TW (2) TWI675041B (enExample)
WO (1) WO2014180852A1 (enExample)

Families Citing this family (36)

* 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
US10704021B2 (en) 2012-03-15 2020-07-07 Flodesign Sonics, Inc. Acoustic perfusion devices
US9950282B2 (en) 2012-03-15 2018-04-24 Flodesign Sonics, Inc. Electronic configuration and control for acoustic standing wave generation
US10967298B2 (en) 2012-03-15 2021-04-06 Flodesign Sonics, Inc. Driver and control for variable impedence load
SG11201502918RA (en) * 2012-10-24 2015-05-28 Genzyme Corp Elution of biomolecules from multi-modal resins using mes and mops as mobile phase modifiers
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
US9725710B2 (en) 2014-01-08 2017-08-08 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
US11377651B2 (en) 2016-10-19 2022-07-05 Flodesign Sonics, Inc. Cell therapy processes utilizing acoustophoresis
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
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
US11474085B2 (en) 2015-07-28 2022-10-18 Flodesign Sonics, Inc. Expanded bed affinity selection
US11459540B2 (en) 2015-07-28 2022-10-04 Flodesign Sonics, Inc. Expanded bed affinity selection
US20170101437A1 (en) * 2015-10-09 2017-04-13 Hetero Drugs Ltd. Process for purification of darbepoetin alfa
US11085035B2 (en) 2016-05-03 2021-08-10 Flodesign Sonics, Inc. Therapeutic cell washing, concentration, and separation utilizing acoustophoresis
US11214789B2 (en) 2016-05-03 2022-01-04 Flodesign Sonics, Inc. Concentration and washing of particles with acoustics
US20190211055A1 (en) * 2016-09-14 2019-07-11 Kinbio Ltd. Methods of purifying and qualifying antibodies
JP2020513248A (ja) 2016-10-19 2020-05-14 フロデザイン ソニックス, インク.Flodesign Sonics, Inc. 音響による親和性細胞抽出
US11697672B2 (en) * 2017-03-24 2023-07-11 Council Of Scientific & Industrial Research Process for the purification of recombinant antibody fragments
GB201711481D0 (en) * 2017-07-17 2017-08-30 Ucb Biopharma Sprl Protein purification
CN111065735B (zh) * 2017-08-31 2023-07-07 株式会社绿十字 用于纯化硫酸酯酶蛋白的方法
US10785574B2 (en) 2017-12-14 2020-09-22 Flodesign Sonics, Inc. Acoustic transducer driver and controller
WO2019183334A1 (en) 2018-03-21 2019-09-26 Waters Technologies Corporation Non-antibody high-affinity-based sample preparation, sorbents, devices and methods
EP3546475A1 (en) * 2018-03-27 2019-10-02 Sanofi Full flow-through process for purifying recombinant proteins
US12071607B2 (en) * 2018-06-01 2024-08-27 Lonza Ltd. Midscale model for organic growth and phasing
KR102337683B1 (ko) * 2018-09-21 2021-12-13 주식회사 녹십자 고효율 항-tfpi 항체 조성물
EP3636657A1 (en) * 2018-10-08 2020-04-15 Ablynx N.V. Chromatography-free antibody purification method
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
JP7568638B2 (ja) 2019-04-03 2024-10-16 ジェンザイム・コーポレーション 組換えタンパク質の連続的生産
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
KR20220069043A (ko) * 2019-09-23 2022-05-26 머크 샤프 앤드 돔 코포레이션 감소된 숙주 세포 단백질 및 증가된 폴리소르베이트-80 안정성을 갖는 항-ctla4 모노클로날 항체를 포함하는 방법 및 조성물
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 (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101730707A (zh) * 2007-07-11 2010-06-09 诺沃-诺迪斯克有限公司 使用混合式或多模式树脂来纯化因子ⅷ
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
TW201313735A (zh) * 2011-08-19 2013-04-01 Emd Millipore Corp 用於減少蛋白質純化期間樣本中一或多種雜質含量之方法

Family Cites Families (30)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0788395B2 (ja) 1987-10-23 1995-09-27 シェリング・コーポレーション タンパク質の精製方法
JP4057049B2 (ja) * 1993-09-21 2008-03-05 ヘモソル インコーポレーテッド 置換クロマトグラフィー法および精製ヘモグロビン産物
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
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
CA2567748A1 (en) 2004-04-21 2005-11-03 The Brigham And Women's Hospital, Inc. Poly-n-acetyl glucosamine (pnag/dpnag)-binding peptides and methods of use thereof
BRPI0518216C8 (pt) * 2004-10-21 2017-03-21 Ge Healthcare Bio Sciences Ab ligante de cromatografia, métodos de preparação de uma matriz de separação, e de separação de um ou mais anticorpos de um ou mais outros compostos em uma amostra líquida, matriz de separação, e, coluna de cromatografia descartável.
SG10201912554TA (en) 2005-03-23 2020-02-27 Genmab As 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
BRPI0819312A2 (pt) 2007-11-16 2020-09-15 The Rockefeller University específico anticorpo para a forma protofibril de proteínas amilóide beta
TWI472339B (zh) * 2008-01-30 2015-02-11 Genentech Inc 包含結合至her2結構域ii之抗體及其酸性變異體的組合物
CA2717129A1 (en) * 2008-02-29 2009-09-11 Biogen Idec Ma Inc. Purified immunoglobulin fusion proteins and methods of their purification
JP2011523408A (ja) * 2008-05-15 2011-08-11 ノボ・ノルデイスク・エー/エス 抗体精製方法
CA2730018A1 (en) * 2008-07-18 2010-01-21 Talecris Biotherapeutics, Inc. Method of preparing alpha-1 proteinase inhibitor
US8497358B2 (en) 2008-12-19 2013-07-30 Takeda Pharmaceutical Company Limited Antibody purification method
CA2748809A1 (en) 2009-01-13 2010-07-22 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
WO2011017514A1 (en) * 2009-08-07 2011-02-10 Millipore Corporation Methods for purifying a target protein from one or more impurities in a sample
US9527010B2 (en) * 2009-09-25 2016-12-27 Ge Healthcare Bio-Sciences Corp. Separation system and method
WO2011049798A1 (en) 2009-10-20 2011-04-28 Merck Sharp & Dohme Corp. Use of mixed mode chromatography for the capture and purification of basic antibody products
ES2534936T3 (es) 2010-08-02 2015-04-30 Ratiopharm Gmbh Método para producir y purificar una sialiltransferasa soluble activa
WO2012125735A1 (en) * 2011-03-15 2012-09-20 Abott Laboratories An integrated approach to the isolation and purification of antibodies
CN107421796B (zh) 2011-06-17 2021-05-04 罗氏血液诊断股份有限公司 用于生物样品的组织加工的溶液
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
WO2013075740A1 (en) 2011-11-23 2013-05-30 Sanofi Antibody purification method

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101730707A (zh) * 2007-07-11 2010-06-09 诺沃-诺迪斯克有限公司 使用混合式或多模式树脂来纯化因子ⅷ
CN101730707B (zh) 2007-07-11 2014-12-17 诺沃-诺迪斯克有限公司 使用混合式或多模式树脂来纯化因子ⅷ
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
TW201313735A (zh) * 2011-08-19 2013-04-01 Emd Millipore Corp 用於減少蛋白質純化期間樣本中一或多種雜質含量之方法

Also Published As

Publication number Publication date
WO2014180852A1 (en) 2014-11-13
AU2014264697A1 (en) 2015-11-26
US10793622B2 (en) 2020-10-06
RU2662668C2 (ru) 2018-07-26
EP3301115B1 (en) 2021-11-10
CN105358572A (zh) 2016-02-24
DK2994485T3 (en) 2018-04-23
EP2994485B1 (en) 2018-01-10
US20160083454A1 (en) 2016-03-24
JP6463734B2 (ja) 2019-02-06
HUE038741T2 (hu) 2018-11-28
IL242408B (en) 2020-04-30
ES2905675T3 (es) 2022-04-11
BR112015027812B1 (pt) 2021-03-30
TWI631132B (zh) 2018-08-01
ES2665645T3 (es) 2018-04-26
AU2014264697B2 (en) 2019-08-22
BR112015027812A2 (pt) 2017-07-25
CA2911462C (en) 2021-04-06
CN116003579A (zh) 2023-04-25
TW201908331A (zh) 2019-03-01
SG11201508968XA (en) 2015-11-27
CY1125281T1 (el) 2023-06-09
RU2015151869A (ru) 2017-06-13
HUE057119T2 (hu) 2022-04-28
MX368177B (es) 2019-09-23
JP2019104735A (ja) 2019-06-27
MX2015015482A (es) 2016-03-21
EP2994485A1 (en) 2016-03-16
EP3301115A1 (en) 2018-04-04
JP2016519137A (ja) 2016-06-30
CA2911462A1 (en) 2014-11-13
DK3301115T3 (da) 2022-01-31
NO2994485T3 (enExample) 2018-06-09
KR20160005047A (ko) 2016-01-13
TW201522363A (zh) 2015-06-16
KR102272851B1 (ko) 2021-07-02

Similar Documents

Publication Publication Date Title
TWI675041B (zh) 用於純化抗體之連續多步驟方法
JP6437311B2 (ja) ビス−トリス緩衝液を用いたタンパク質の精製方法
AU2019246328B2 (en) Full flow-through process for purifying recombinant proteins

Legal Events

Date Code Title Description
MM4A Annulment or lapse of patent due to non-payment of fees