CN106536565A - 一种用于纯化TNFR‑Fc融合蛋白的方法 - Google Patents

一种用于纯化TNFR‑Fc融合蛋白的方法 Download PDF

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Publication number
CN106536565A
CN106536565A CN201580038801.XA CN201580038801A CN106536565A CN 106536565 A CN106536565 A CN 106536565A CN 201580038801 A CN201580038801 A CN 201580038801A CN 106536565 A CN106536565 A CN 106536565A
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protein
tnfr
fusion protein
eluting
mixture
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Chinese (zh)
Inventor
阿比尔·班纳吉
钱德拉纳特·甘纳巴迪
索拉·拉斯顿·莫迪
阿肖克·米什拉
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Lupin Ltd
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Lupin Ltd
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    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D15/00Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08Selective adsorption, e.g. chromatography
    • B01D15/10Selective adsorption, e.g. chromatography characterised by constructional or operational features
    • B01D15/12Selective adsorption, e.g. chromatography characterised by constructional or operational features relating to the preparation of the feed
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D15/00Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08Selective adsorption, e.g. chromatography
    • B01D15/10Selective adsorption, e.g. chromatography characterised by constructional or operational features
    • B01D15/20Selective adsorption, e.g. chromatography characterised by constructional or operational features relating to the conditioning of the sorbent material
    • B01D15/203Equilibration or regeneration
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D15/00Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08Selective adsorption, e.g. chromatography
    • B01D15/26Selective adsorption, e.g. chromatography characterised by the separation mechanism
    • B01D15/30Partition chromatography
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D15/00Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08Selective adsorption, e.g. chromatography
    • B01D15/26Selective adsorption, e.g. chromatography characterised by the separation mechanism
    • B01D15/36Selective adsorption, e.g. chromatography characterised by the separation mechanism involving ionic interaction, e.g. ion-exchange, ion-pair, ion-suppression or ion-exclusion
    • B01D15/361Ion-exchange
    • B01D15/363Anion-exchange
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D15/00Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08Selective adsorption, e.g. chromatography
    • B01D15/26Selective adsorption, e.g. chromatography characterised by the separation mechanism
    • B01D15/38Selective adsorption, e.g. chromatography characterised by the separation mechanism involving specific interaction not covered by one or more of groups B01D15/265 and B01D15/30 - B01D15/36, e.g. affinity, ligand exchange or chiral chromatography
    • B01D15/3804Affinity chromatography
    • B01D15/3809Affinity chromatography of the antigen-antibody type, e.g. protein A, G or L chromatography
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D15/00Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08Selective adsorption, e.g. chromatography
    • B01D15/26Selective adsorption, e.g. chromatography characterised by the separation mechanism
    • B01D15/38Selective adsorption, e.g. chromatography characterised by the separation mechanism involving specific interaction not covered by one or more of groups B01D15/265 and B01D15/30 - B01D15/36, e.g. affinity, ligand exchange or chiral chromatography
    • B01D15/3847Multimodal interactions
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D15/00Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08Selective adsorption, e.g. chromatography
    • B01D15/42Selective adsorption, e.g. chromatography characterised by the development mode, e.g. by displacement or by elution
    • B01D15/424Elution mode
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/705Receptors; Cell surface antigens; Cell surface determinants
    • C07K14/70578NGF-receptor/TNF-receptor superfamily, e.g. CD27, CD30, CD40, CD95
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/705Receptors; Cell surface antigens; Cell surface determinants
    • C07K14/715Receptors; Cell surface antigens; Cell surface determinants for cytokines; for lymphokines; for interferons
    • C07K14/7151Receptors; Cell surface antigens; Cell surface determinants for cytokines; for lymphokines; for interferons for tumor necrosis factor [TNF], for lymphotoxin [LT]
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2319/00Fusion polypeptide
    • C07K2319/30Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto

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  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Immunology (AREA)
  • Cell Biology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • General Health & Medical Sciences (AREA)
  • Genetics & Genomics (AREA)
  • Medicinal Chemistry (AREA)
  • Zoology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Toxicology (AREA)
  • Peptides Or Proteins (AREA)
  • Enzymes And Modification Thereof (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
CN201580038801.XA 2014-06-13 2015-06-13 一种用于纯化TNFR‑Fc融合蛋白的方法 Pending CN106536565A (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
IN1919/MUM/2014 2014-06-13
IN1919MU2014 2014-06-13
PCT/IB2015/054494 WO2015189832A1 (en) 2014-06-13 2015-06-13 Process for the purification of tnfr:fc fusion protein

Publications (1)

Publication Number Publication Date
CN106536565A true CN106536565A (zh) 2017-03-22

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US (1) US10556942B2 (enExample)
EP (1) EP3155009A1 (enExample)
JP (1) JP6747985B2 (enExample)
CN (1) CN106536565A (enExample)
AU (1) AU2015273049B2 (enExample)
BR (1) BR112016029157A8 (enExample)
CA (1) CA2951766A1 (enExample)
MA (1) MA40232A (enExample)
MX (1) MX2016016318A (enExample)
PH (1) PH12016502482A1 (enExample)
RU (1) RU2698654C2 (enExample)
WO (1) WO2015189832A1 (enExample)

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CN111032674A (zh) * 2017-08-30 2020-04-17 阿雷斯贸易股份有限公司 蛋白质纯化方法
CN111344410A (zh) * 2017-08-17 2020-06-26 济世易为生物有限公司 从宿主细胞半乳糖凝集素和其他污染物中纯化糖基化蛋白的方法
CN112876567A (zh) * 2019-11-29 2021-06-01 广东菲鹏制药股份有限公司 Fc融合蛋白及其纯化方法
CN113563469A (zh) * 2020-04-28 2021-10-29 江苏中新医药有限公司 高回收率纯化阿达木单抗的方法
CN114206923A (zh) * 2019-07-08 2022-03-18 参天堂制药株式会社(韩国) 眼用蛋白质药物的精制方法

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US11566082B2 (en) 2014-11-17 2023-01-31 Cytiva Bioprocess R&D Ab Mutated immunoglobulin-binding polypeptides
WO2016149139A1 (en) * 2015-03-13 2016-09-22 Samsung Bioepis Co., Ltd. Anti-tnf-alpha polypeptide composition and use thereof
US10889615B2 (en) 2016-05-11 2021-01-12 Cytiva Bioprocess R&D Ab Mutated immunoglobulin-binding polypeptides
US10654887B2 (en) 2016-05-11 2020-05-19 Ge Healthcare Bio-Process R&D Ab Separation matrix
US11708390B2 (en) 2016-05-11 2023-07-25 Cytiva Bioprocess R&D Ab Method of storing a separation matrix
ES2909833T3 (es) 2016-05-11 2022-05-10 Cytiva Bioprocess R & D Ab Método de limpieza y/o desinfección de una matriz de separación
US10730908B2 (en) 2016-05-11 2020-08-04 Ge Healthcare Bioprocess R&D Ab Separation method
EP3455243B1 (en) 2016-05-11 2021-03-24 Cytiva BioProcess R&D AB Separation matrix
JP7031934B2 (ja) 2016-05-11 2022-03-08 サイティバ・バイオプロセス・アールアンドディ・アクチボラグ 分離マトリックス
US10703774B2 (en) 2016-09-30 2020-07-07 Ge Healthcare Bioprocess R&D Ab Separation method
US12448411B2 (en) 2016-09-30 2025-10-21 Cytiva Bioprocess R&D Ab Separation method
US11952399B2 (en) * 2018-12-18 2024-04-09 Amgen Inc. Methods for purifying proteins
US20220098279A1 (en) * 2019-01-30 2022-03-31 Amgen Inc. Aflibercept attributes and methods of characterizing and modifying thereof
EP4118093A4 (en) * 2020-03-11 2024-04-17 Dr. Reddy's Laboratories Ltd. METHOD FOR PURIFYING A FC FUSION PROTEIN
WO2022234412A1 (en) * 2021-05-03 2022-11-10 Lupin Limited A process for purification of fc-fusion proteins
CA3233422A1 (en) * 2021-09-28 2023-04-06 Kashiv Biosciences, Llc An improved process for purification of fusion protein
EP4408857A4 (en) * 2021-09-28 2025-11-05 Kashiv Biosciences Llc IMPROVED PROCESS FOR PURIFICATION OF FUSION PROTEIN
CA3233419A1 (en) * 2021-09-28 2023-04-06 Kashiv Biosciences, Llc An improved process for purification of protein
MX2024004764A (es) * 2021-10-19 2024-07-04 Alteogen Inc Procedimiento para purificar una proteína de fusión que tiene un dominio fc de igg.
US20250026784A1 (en) * 2021-11-29 2025-01-23 Tosoh Corporation Separation method of antibody
CN119060168A (zh) * 2024-09-26 2024-12-03 广东丸美生物技术股份有限公司 一种具有低电导率的重组胶原蛋白溶液及其制备方法和应用

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US20090306351A1 (en) * 2006-03-16 2009-12-10 Amgen Inc. Wash Buffer And Method Of Using
CN102712673A (zh) * 2010-01-22 2012-10-03 贝林格尔.英格海姆国际有限公司 用于纯化含fc的蛋白的色谱方法
WO2012176158A1 (en) * 2011-06-24 2012-12-27 Dr. Reddy's Laboratories Limited Purification of chimeric protein
CN103814044A (zh) * 2011-07-08 2014-05-21 默沙东公司 纯化fc-融合蛋白的方法
WO2013025079A1 (en) * 2011-08-17 2013-02-21 Hanwha Chemical Corporation Method for preparing active form of tnfr-fc fusion protein
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Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111344410A (zh) * 2017-08-17 2020-06-26 济世易为生物有限公司 从宿主细胞半乳糖凝集素和其他污染物中纯化糖基化蛋白的方法
CN111344410B (zh) * 2017-08-17 2023-09-15 济世易为生物有限公司 从宿主细胞半乳糖凝集素和其他污染物中纯化糖基化蛋白的方法
CN111032674A (zh) * 2017-08-30 2020-04-17 阿雷斯贸易股份有限公司 蛋白质纯化方法
CN111032674B (zh) * 2017-08-30 2024-02-27 阿雷斯贸易股份有限公司 蛋白质纯化方法
CN114206923A (zh) * 2019-07-08 2022-03-18 参天堂制药株式会社(韩国) 眼用蛋白质药物的精制方法
CN112876567A (zh) * 2019-11-29 2021-06-01 广东菲鹏制药股份有限公司 Fc融合蛋白及其纯化方法
CN113563469A (zh) * 2020-04-28 2021-10-29 江苏中新医药有限公司 高回收率纯化阿达木单抗的方法

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Publication number Publication date
CA2951766A1 (en) 2015-12-17
RU2017100005A3 (enExample) 2019-02-28
RU2017100005A (ru) 2018-07-13
US20170152298A1 (en) 2017-06-01
MA40232A (fr) 2017-04-19
AU2015273049A1 (en) 2017-01-12
MX2016016318A (es) 2017-06-12
PH12016502482A1 (en) 2017-04-10
BR112016029157A8 (pt) 2021-07-06
BR112016029157A2 (pt) 2017-08-22
RU2698654C2 (ru) 2019-08-28
AU2015273049B2 (en) 2019-11-14
JP2017521389A (ja) 2017-08-03
JP6747985B2 (ja) 2020-08-26
US10556942B2 (en) 2020-02-11
EP3155009A1 (en) 2017-04-19
WO2015189832A1 (en) 2015-12-17

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Inventor after: Abbil Banerjee

Inventor after: Chandranath Gannabad

Inventor after: Lasdun Sola Modi

Inventor after: Ashok Mishra

Inventor before: Abbil Banerjee

Inventor before: Chandranath Gannabad

Inventor before: Sola Lasdun Modi

Inventor before: Ashok Mishra

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Application publication date: 20170322