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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Ceased legal-status Critical Current
Anticipated expiration legal-status Critical

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    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D15/00—Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08—Selective adsorption, e.g. chromatography
    • B01D15/10—Selective adsorption, e.g. chromatography characterised by constructional or operational features
    • B01D15/12—Selective adsorption, e.g. chromatography characterised by constructional or operational features relating to the preparation of the feed
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D15/00—Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08—Selective adsorption, e.g. chromatography
    • B01D15/10—Selective adsorption, e.g. chromatography characterised by constructional or operational features
    • B01D15/20—Selective adsorption, e.g. chromatography characterised by constructional or operational features relating to the conditioning of the sorbent material
    • B01D15/203—Equilibration or regeneration
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D15/00—Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08—Selective adsorption, e.g. chromatography
    • B01D15/26—Selective adsorption, e.g. chromatography characterised by the separation mechanism
    • B01D15/30—Partition chromatography
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D15/00—Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08—Selective adsorption, e.g. chromatography
    • B01D15/26—Selective adsorption, e.g. chromatography characterised by the separation mechanism
    • B01D15/36—Selective adsorption, e.g. chromatography characterised by the separation mechanism involving ionic interaction, e.g. ion-exchange, ion-pair, ion-suppression or ion-exclusion
    • B01D15/361—Ion-exchange
    • B01D15/363—Anion-exchange
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D15/00—Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08—Selective adsorption, e.g. chromatography
    • B01D15/26—Selective adsorption, e.g. chromatography characterised by the separation mechanism
    • B01D15/38—Selective 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
    • B01D15/3804—Affinity chromatography
    • B01D15/3809—Affinity chromatography of the antigen-antibody type, e.g. protein A, G or L chromatography
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D15/00—Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08—Selective adsorption, e.g. chromatography
    • B01D15/26—Selective adsorption, e.g. chromatography characterised by the separation mechanism
    • B01D15/38—Selective 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
    • B01D15/3847—Multimodal interactions
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D15/00—Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08—Selective adsorption, e.g. chromatography
    • B01D15/42—Selective adsorption, e.g. chromatography characterised by the development mode, e.g. by displacement or by elution
    • B01D15/424—Elution mode
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/705—Receptors; Cell surface antigens; Cell surface determinants
    • C07K14/70578—NGF-receptor/TNF-receptor superfamily, e.g. CD27, CD30, CD40, CD95
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/705—Receptors; Cell surface antigens; Cell surface determinants
    • C07K14/715—Receptors; Cell surface antigens; Cell surface determinants for cytokines; for lymphokines; for interferons
    • C07K14/7151—Receptors; Cell surface antigens; Cell surface determinants for cytokines; for lymphokines; for interferons for tumor necrosis factor [TNF], for lymphotoxin [LT]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C07K2319/30—Non-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)
  • Chemical Kinetics & Catalysis (AREA)
  • Analytical Chemistry (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Immunology (AREA)
  • Zoology (AREA)
  • Biophysics (AREA)
  • General Health & Medical Sciences (AREA)
  • Genetics & Genomics (AREA)
  • Medicinal Chemistry (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Toxicology (AREA)
  • Cell Biology (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 (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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US11566082B2 (en) 2014-11-17 2023-01-31 Cytiva Bioprocess R&D Ab Mutated immunoglobulin-binding polypeptides
US20180079796A1 (en) * 2015-03-13 2018-03-22 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
WO2017194592A1 (en) 2016-05-11 2017-11-16 Ge Healthcare Bioprocess R&D Ab Method of storing a separation matrix
EP3455241B1 (en) 2016-05-11 2022-02-23 Cytiva BioProcess R&D AB Method of cleaning and/or sanitizing a separation matrix
US10703774B2 (en) 2016-09-30 2020-07-07 Ge Healthcare Bioprocess R&D Ab Separation method
US10654887B2 (en) 2016-05-11 2020-05-19 Ge Healthcare Bio-Process R&D Ab Separation matrix
JP7122974B2 (ja) 2016-05-11 2022-08-22 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 変異免疫グロブリン結合ポリペプチド
US12448411B2 (en) 2016-09-30 2025-10-21 Cytiva Bioprocess R&D Ab Separation method
MY199833A (en) * 2017-08-17 2023-11-24 Just Evotec Biologics Inc Method of purifying glycosylated protein from host cell galectins and other contaminants
EP3676281A1 (en) * 2017-08-30 2020-07-08 Ares Trading S.A. Method for purifying proteins
US11952399B2 (en) * 2018-12-18 2024-04-09 Amgen Inc. Methods for purifying proteins
MX2021008983A (es) * 2019-01-30 2021-09-08 Amgen Inc Atributos de aflibercept y metodos de caracterizacion y modificacion de los mismos.
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
WO2021181417A1 (en) * 2020-03-11 2021-09-16 Dr. Reddy's Laboratories Limited METHOD OF PURIFYING AN 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
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
AU2022354256A1 (en) * 2021-09-28 2024-04-11 Kashiv Biosciences, Llc An improved process for purification of fusion protein
EP4421089A4 (en) * 2021-10-19 2026-01-07 Alteogen Inc METHOD FOR PURIFYING A FUSION PROTEIN HAVING AN IGG FC DOMAIN
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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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
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
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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US7294481B1 (en) 1999-01-05 2007-11-13 Immunex Corporation Method for producing recombinant proteins
CA2476934C (en) 2002-02-27 2009-06-16 Immunex Corporation Stabilized tnfr-fc composition comprising arginine
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US8263750B2 (en) * 2006-03-16 2012-09-11 Amgen Inc. Method for purifying a protein using protein-A affinity chromatography using an intermediate wash step
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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
BR112016029157A8 (pt) 2021-07-06
US20170152298A1 (en) 2017-06-01
JP2017521389A (ja) 2017-08-03
RU2017100005A3 (enExample) 2019-02-28
MX2016016318A (es) 2017-06-12
RU2017100005A (ru) 2018-07-13
EP3155009A1 (en) 2017-04-19
JP6747985B2 (ja) 2020-08-26
WO2015189832A1 (en) 2015-12-17
PH12016502482A1 (en) 2017-04-10
AU2015273049A1 (en) 2017-01-12
RU2698654C2 (ru) 2019-08-28
BR112016029157A2 (pt) 2017-08-22
CN106536565A (zh) 2017-03-22
CA2951766A1 (en) 2015-12-17
MA40232A (fr) 2017-04-19
US10556942B2 (en) 2020-02-11

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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

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