RU2662668C2 - Способ непрерывной многостадийной очистки антител - Google Patents
Способ непрерывной многостадийной очистки антител Download PDFInfo
- Publication number
- RU2662668C2 RU2662668C2 RU2015151869A RU2015151869A RU2662668C2 RU 2662668 C2 RU2662668 C2 RU 2662668C2 RU 2015151869 A RU2015151869 A RU 2015151869A RU 2015151869 A RU2015151869 A RU 2015151869A RU 2662668 C2 RU2662668 C2 RU 2662668C2
- Authority
- RU
- Russia
- Prior art keywords
- chromatographic
- protein
- buffer
- passing
- chromatographic column
- Prior art date
Links
Images
Classifications
-
- 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
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)
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 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| RU2015151869A RU2015151869A (ru) | 2017-06-13 |
| RU2662668C2 true RU2662668C2 (ru) | 2018-07-26 |
Family
ID=48430636
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2015151869A RU2662668C2 (ru) | 2013-05-06 | 2014-05-06 | Способ непрерывной многостадийной очистки антител |
Country Status (19)
| Country | Link |
|---|---|
| US (1) | US10793622B2 (enExample) |
| EP (2) | EP3301115B1 (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) | HUE038741T2 (enExample) |
| IL (1) | IL242408B (enExample) |
| MX (1) | MX368177B (enExample) |
| NO (1) | NO2994485T3 (enExample) |
| RU (1) | RU2662668C2 (enExample) |
| SG (1) | SG11201508968XA (enExample) |
| TW (2) | TWI631132B (enExample) |
| WO (1) | WO2014180852A1 (enExample) |
Families Citing this family (36)
| 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 |
| US10967298B2 (en) | 2012-03-15 | 2021-04-06 | Flodesign Sonics, Inc. | Driver and control for variable impedence load |
| US9950282B2 (en) | 2012-03-15 | 2018-04-24 | Flodesign Sonics, Inc. | Electronic configuration and control for acoustic standing wave generation |
| MX379269B (es) * | 2012-10-24 | 2025-03-11 | Genzyme Corp | Elucion de biomoleculas de resinas multimodales utilizando mes y mops como modificadores de fase movil. |
| KR20160054597A (ko) * | 2013-09-17 | 2016-05-16 | 가부시키가이샤 가네카 | 신규 항체 정제 방법 및 그로부터 얻어지는 항체, 및 양이온 교환기를 사용한 신규 항체 정제법 및 그로부터 얻어지는 항체 |
| CN105939767B (zh) | 2014-01-08 | 2018-04-06 | 弗洛设计声能学公司 | 具有双声电泳腔的声电泳装置 |
| GB201503578D0 (en) * | 2015-03-03 | 2015-04-15 | Ge Healthcare Bio Sciences Ab | Sanitization method for affinity chromatography matrices |
| US11021699B2 (en) | 2015-04-29 | 2021-06-01 | FioDesign Sonics, Inc. | Separation using angled acoustic waves |
| US11708572B2 (en) | 2015-04-29 | 2023-07-25 | Flodesign Sonics, Inc. | Acoustic cell separation techniques and processes |
| 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 |
| 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 |
| 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 |
| EP3529347A1 (en) | 2016-10-19 | 2019-08-28 | Flodesign Sonics, Inc. | Affinity cell extraction by acoustics |
| MX2019011343A (es) * | 2017-03-24 | 2019-11-18 | Council Scient Ind Res | Un procedimiento para la purificacion de fragmentos de anticuerpos recombinantes. |
| 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 |
| CN114900773A (zh) | 2017-12-14 | 2022-08-12 | 弗洛设计声能学公司 | 声泳系统及其操作方法、控制声换能器及声学系统的方法 |
| US11155575B2 (en) | 2018-03-21 | 2021-10-26 | Waters Technologies Corporation | Non-antibody high-affinity-based sample preparation, sorbent, 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 |
| CN113825840A (zh) * | 2019-04-03 | 2021-12-21 | 建新公司 | 重组蛋白的连续生产 |
| 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 |
| CA3154726A1 (en) * | 2019-09-23 | 2021-04-01 | Merck Sharp & Dohme Corp. | Methods and compositions comprising an anti-ctla4 monoclonal antibody with reduced host cell proteins and increased polysorbate-80 stability |
| 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 (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| RU2145873C1 (ru) * | 1993-09-21 | 2000-02-27 | Хемосол Инк. | Способ очистки гемоглобина в коммерческом масштабе |
Family Cites Families (34)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| ATE121418T1 (de) | 1987-10-23 | 1995-05-15 | Schering Corp | Verfahren zur proteinreinigung. |
| 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 |
| PL1745075T3 (pl) | 2004-04-21 | 2013-09-30 | Brigham & Womens Hospital Inc | Peptydy wiążące poli-N-acetyloglukozaminę (PNAG/DPNAG) i sposoby ich zastosowania |
| KR101243425B1 (ko) * | 2004-10-21 | 2013-03-13 | 지이 헬스케어 바이오-사이언시스 에이비 | 항체의 정제 방법 |
| EP2551282A3 (en) | 2005-03-23 | 2013-02-13 | 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 |
| BRPI0814220B8 (pt) | 2007-07-11 | 2021-05-25 | Novo Nordisk As | purificação de fator viii usando uma resina multimodal ou de modo misto |
| AU2008322523B2 (en) | 2007-11-16 | 2013-10-10 | The Rockefeller University | Antibodies specific for the protofibril form of beta-amyloid protein |
| 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 |
| JP2011514895A (ja) * | 2008-02-29 | 2011-05-12 | バイオジェン・アイデック・エムエイ・インコーポレイテッド | 精製免疫グロブリン融合タンパク質およびその精製方法 |
| CN103396480A (zh) * | 2008-05-15 | 2013-11-20 | 诺沃—诺迪斯克有限公司 | 抗体纯化方法 |
| NZ590257A (en) * | 2008-07-18 | 2012-08-31 | Grifols Therapeutics Inc | Method of preparing alpha-1 proteinase inhibitor |
| WO2010071208A1 (ja) | 2008-12-19 | 2010-06-24 | 武田薬品工業株式会社 | 抗体の精製方法 |
| CN102272146A (zh) | 2009-01-13 | 2011-12-07 | 通用电气健康护理生物科学股份公司 | 用带负电的聚合物沉淀生物分子 |
| KR101224468B1 (ko) * | 2009-05-20 | 2013-01-23 | 주식회사 파멥신 | 신규한 형태의 이중표적항체 및 그 용도 |
| US8536316B2 (en) * | 2009-08-07 | 2013-09-17 | Emd Millipore Corporation | Methods for purifying a target protein from one or more impurities in a sample |
| BR112012004697B8 (pt) * | 2009-09-01 | 2021-05-25 | Genentech Inc | método para purificar um polipeptídeo compreendendo uma região ch2/ch3 |
| 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 |
| WO2011090719A2 (en) | 2009-12-29 | 2011-07-28 | Dr. Reddy's Laboratories Ltd. | Protein purification by ion exchange |
| ES2534936T3 (es) | 2010-08-02 | 2015-04-30 | Ratiopharm Gmbh | Método para producir y purificar una sialiltransferasa soluble activa |
| US20120238730A1 (en) * | 2011-03-15 | 2012-09-20 | Abbott Laboratories | Integrated approach to the isolation and purification of antibodies |
| EP2691411B1 (en) * | 2011-03-29 | 2020-02-26 | GlaxoSmithKline LLC | Buffer system for protein purification |
| 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 |
| BR112014009866A2 (pt) * | 2011-10-25 | 2018-09-04 | Onclave Therapeutics Limited | formulações de anticorpos e métodos |
| WO2013075740A1 (en) | 2011-11-23 | 2013-05-30 | Sanofi | Antibody purification method |
-
2014
- 2014-05-06 DK DK14722194.9T patent/DK2994485T3/en active
- 2014-05-06 CA CA2911462A patent/CA2911462C/en active Active
- 2014-05-06 NO NO14722194A patent/NO2994485T3/no unknown
- 2014-05-06 EP EP17200909.4A patent/EP3301115B1/en active Active
- 2014-05-06 CN CN202310118200.6A patent/CN116003579A/zh active Pending
- 2014-05-06 DK DK17200909.4T patent/DK3301115T3/da active
- 2014-05-06 AU AU2014264697A patent/AU2014264697B2/en active Active
- 2014-05-06 KR KR1020157032904A patent/KR102272851B1/ko active Active
- 2014-05-06 RU RU2015151869A patent/RU2662668C2/ru active
- 2014-05-06 WO PCT/EP2014/059246 patent/WO2014180852A1/en not_active Ceased
- 2014-05-06 MX MX2015015482A patent/MX368177B/es active IP Right Grant
- 2014-05-06 US US14/889,397 patent/US10793622B2/en active Active
- 2014-05-06 BR BR112015027812-4A patent/BR112015027812B1/pt active IP Right Grant
- 2014-05-06 SG SG11201508968XA patent/SG11201508968XA/en unknown
- 2014-05-06 EP EP14722194.9A patent/EP2994485B1/en active Active
- 2014-05-06 ES ES14722194.9T patent/ES2665645T3/es active Active
- 2014-05-06 ES ES17200909T patent/ES2905675T3/es active Active
- 2014-05-06 JP JP2016512344A patent/JP6463734B2/ja active Active
- 2014-05-06 HU HUE14722194A patent/HUE038741T2/hu unknown
- 2014-05-06 TW TW103116153A patent/TWI631132B/zh not_active IP Right Cessation
- 2014-05-06 CN CN201480038360.9A patent/CN105358572A/zh active Pending
- 2014-05-06 TW TW107117528A patent/TWI675041B/zh not_active IP Right Cessation
- 2014-05-06 HU HUE17200909A patent/HUE057119T2/hu unknown
-
2015
- 2015-11-02 IL IL242408A patent/IL242408B/en active IP Right Grant
-
2019
- 2019-01-10 JP JP2019002288A patent/JP2019104735A/ja active Pending
-
2022
- 2022-02-09 CY CY20221100113T patent/CY1125281T1/el unknown
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| RU2145873C1 (ru) * | 1993-09-21 | 2000-02-27 | Хемосол Инк. | Способ очистки гемоглобина в коммерческом масштабе |
Non-Patent Citations (4)
| Title |
|---|
| Follman D. K., Fahrner R. L. Factorial screening of antibody purification processes using three chromatography steps without protein A. Journal of chromatography A. - 2004. - Vol. 1024. - n. 1. - P. 79-85. * |
| Mahajan E., George A., Wolk B. Improving affinity chromatography resin efficiency using semi-continuous chromatography. Journal of chromatography A. - 2012. - Vol. 1227. - P. 154-162. * |
| Mahajan E., George A., Wolk B. Improving affinity chromatography resin efficiency using semi-continuous chromatography. Journal of chromatography A. - 2012. - Vol. 1227. - P. 154-162. Pollock J. et al. Optimising the design and operation of semi-continuous affinity chromatography for clinical and commercial manufacture. Journal of Chromatography A. - 2013. - Vol. 1284. - P. 17-27. Follman D. K., Fahrner R. L. Factorial screening of antibody purification processes using three chromatography steps without protein A. Journal of chromatography A. - 2004. - Vol. 1024. - n. 1. - P. 79-85. * |
| Pollock J. et al. Optimising the design and operation of semi-continuous affinity chromatography for clinical and commercial manufacture. Journal of Chromatography A. - 2013. - Vol. 1284. - P. 17-27. * |
Also Published As
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| JP6463734B2 (ja) | 抗体を精製するための連続的多工程法 | |
| TWI671312B (zh) | 無菌層析法及製法 | |
| US10071364B2 (en) | Sterile affinity chromatography resin | |
| US12391728B2 (en) | Full flow-through process for purifying recombinant proteins | |
| JP7635213B2 (ja) | クロマトグラフィーの使用および再生のためのシステムおよび方法 | |
| HK40091913A (en) | Continuous multistep process for purifying antibodies |