AU2015273049B2 - Process for the purification of TNFR:Fc fusion protein - Google Patents

Process for the purification of TNFR:Fc fusion protein Download PDF

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Publication number
AU2015273049B2
AU2015273049B2 AU2015273049A AU2015273049A AU2015273049B2 AU 2015273049 B2 AU2015273049 B2 AU 2015273049B2 AU 2015273049 A AU2015273049 A AU 2015273049A AU 2015273049 A AU2015273049 A AU 2015273049A AU 2015273049 B2 AU2015273049 B2 AU 2015273049B2
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AU
Australia
Prior art keywords
protein
tnfr
fusion protein
column
hcp
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Ceased
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AU2015273049A
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English (en)
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AU2015273049A1 (en
Inventor
Abir BANERJEE
Chandranath GANAPATHY
Rustom Sorab Mody
Ashok Mishra
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Lupin Ltd
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Lupin Ltd
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Publication of AU2015273049A1 publication Critical patent/AU2015273049A1/en
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Publication of AU2015273049B2 publication Critical patent/AU2015273049B2/en
Ceased legal-status Critical Current
Anticipated expiration legal-status Critical

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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)
AU2015273049A 2014-06-13 2015-06-13 Process for the purification of TNFR:Fc fusion protein Ceased AU2015273049B2 (en)

Applications Claiming Priority (3)

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

Publications (2)

Publication Number Publication Date
AU2015273049A1 AU2015273049A1 (en) 2017-01-12
AU2015273049B2 true AU2015273049B2 (en) 2019-11-14

Family

ID=53524922

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2015273049A Ceased AU2015273049B2 (en) 2014-06-13 2015-06-13 Process for the purification of TNFR:Fc fusion protein

Country Status (12)

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

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US11566082B2 (en) 2014-11-17 2023-01-31 Cytiva Bioprocess R&D Ab Mutated immunoglobulin-binding polypeptides
EP3268042B1 (en) * 2015-03-13 2024-11-27 Samsung Bioepis Co., Ltd. Anti-tnf-alpha polypeptide composition and use thereof
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
US10730908B2 (en) 2016-05-11 2020-08-04 Ge Healthcare Bioprocess R&D Ab Separation method
US10889615B2 (en) 2016-05-11 2021-01-12 Cytiva Bioprocess R&D Ab Mutated immunoglobulin-binding polypeptides
US10703774B2 (en) 2016-09-30 2020-07-07 Ge Healthcare Bioprocess R&D Ab Separation method
WO2017194592A1 (en) 2016-05-11 2017-11-16 Ge Healthcare Bioprocess R&D Ab Method of storing a separation matrix
WO2017194593A1 (en) 2016-05-11 2017-11-16 Ge Healthcare Bioprocess R&D Ab Method of cleaning and/or sanitizing a separation matrix
US10513537B2 (en) 2016-05-11 2019-12-24 Ge Healthcare Bioprocess R&D Ab Separation matrix
US10654887B2 (en) 2016-05-11 2020-05-19 Ge Healthcare Bio-Process R&D Ab Separation matrix
US12448411B2 (en) 2016-09-30 2025-10-21 Cytiva Bioprocess R&D Ab Separation method
EP3668985B1 (en) * 2017-08-17 2021-06-16 Just-Evotec Biologics, Inc. Method of purifying glycosylated protein from host cell galectins and other contaminants
JP2020531557A (ja) * 2017-08-30 2020-11-05 アレス トレーディング ソシエテ アノニム タンパク質の精製方法
US11952399B2 (en) * 2018-12-18 2024-04-09 Amgen Inc. Methods for purifying proteins
JP2022523063A (ja) * 2019-01-30 2022-04-21 アムジエン・インコーポレーテツド アフリベルセプトの属性、並びにその特性決定及び修飾方法
KR102286892B1 (ko) * 2019-07-08 2021-08-06 삼천당제약주식회사 안과용 단백질 제제의 정제방법
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
EP4118093A4 (en) * 2020-03-11 2024-04-17 Dr. Reddy's Laboratories Ltd. METHOD FOR PURIFYING A FC FUSION PROTEIN
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
WO2022234412A1 (en) * 2021-05-03 2022-11-10 Lupin Limited A process for purification of fc-fusion proteins
AU2022358612A1 (en) * 2021-09-28 2024-04-11 Kashiv Biosciences, Llc An improved process of purification of fusion protein
EP4408856A4 (en) * 2021-09-28 2025-11-12 Kashiv Biosciences Llc IMPROVED PROCESS FOR PROTEIN PURIFICATION
US20240400612A1 (en) * 2021-09-28 2024-12-05 Kashiv Biosciences, Llc An improved process for purification of fusion protein
CN118414350A (zh) * 2021-10-19 2024-07-30 阿特根公司 纯化具有igg fc结构域的融合蛋白的方法
EP4435107A4 (en) * 2021-11-29 2025-12-31 Tosoh Corp ANTIBODY ISOLATION METHOD
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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WO2010056550A1 (en) * 2008-10-29 2010-05-20 Wyeth Llc Methods for purification of single domain antigen binding molecules
WO2012176158A1 (en) * 2011-06-24 2012-12-27 Dr. Reddy's Laboratories Limited Purification of chimeric protein
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WO2014043103A1 (en) * 2012-09-11 2014-03-20 Coherus Biosciences, Inc. Correctly folded etanercept in high purity and excellent yield
WO2014078627A1 (en) * 2012-11-19 2014-05-22 Merck Sharp & Dohme Corp. Liquid formulations for tnfr:fc fusion proteins

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WO2010056550A1 (en) * 2008-10-29 2010-05-20 Wyeth Llc Methods for purification of single domain antigen binding molecules
WO2012176158A1 (en) * 2011-06-24 2012-12-27 Dr. Reddy's Laboratories Limited Purification of chimeric protein
WO2014043103A1 (en) * 2012-09-11 2014-03-20 Coherus Biosciences, Inc. Correctly folded etanercept in high purity and excellent yield
CN102911250A (zh) * 2012-09-29 2013-02-06 浙江海正药业股份有限公司 酸性重组蛋白药物的纯化方法
WO2014078627A1 (en) * 2012-11-19 2014-05-22 Merck Sharp & Dohme Corp. Liquid formulations for tnfr:fc fusion proteins

Also Published As

Publication number Publication date
MA40232A (fr) 2017-04-19
RU2698654C2 (ru) 2019-08-28
RU2017100005A3 (https=) 2019-02-28
BR112016029157A8 (pt) 2021-07-06
JP2017521389A (ja) 2017-08-03
PH12016502482A1 (en) 2017-04-10
US10556942B2 (en) 2020-02-11
BR112016029157A2 (pt) 2017-08-22
CN106536565A (zh) 2017-03-22
RU2017100005A (ru) 2018-07-13
JP6747985B2 (ja) 2020-08-26
WO2015189832A1 (en) 2015-12-17
CA2951766A1 (en) 2015-12-17
MX2016016318A (es) 2017-06-12
US20170152298A1 (en) 2017-06-01
EP3155009A1 (en) 2017-04-19
AU2015273049A1 (en) 2017-01-12

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DA3 Amendments made section 104

Free format text: THE NATURE OF THE AMENDMENT IS: AMEND THE NAME OF THE INVENTOR TO READ BANERJEE, ABIR; GANAPATHY, CHANDRANATH; MODY, RUSTOM SORAB AND MISHRA, ASHOK

FGA Letters patent sealed or granted (standard patent)
MK14 Patent ceased section 143(a) (annual fees not paid) or expired