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
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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)
  • Immunology (AREA)
  • Molecular Biology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Toxicology (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • General Health & Medical Sciences (AREA)
  • Genetics & Genomics (AREA)
  • Medicinal Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (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
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 (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
KR20170138426A (ko) * 2015-03-13 2017-12-15 삼성바이오에피스 주식회사 항-tnf-알파 폴리펩티드 조성물 및 그 용도
CN109311949B (zh) 2016-05-11 2022-09-16 思拓凡生物工艺研发有限公司 储存分离基质的方法
US10730908B2 (en) 2016-05-11 2020-08-04 Ge Healthcare Bioprocess R&D Ab Separation method
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
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
US10513537B2 (en) 2016-05-11 2019-12-24 Ge Healthcare Bioprocess R&D Ab Separation matrix
US10889615B2 (en) 2016-05-11 2021-01-12 Cytiva Bioprocess R&D Ab Mutated immunoglobulin-binding polypeptides
WO2017194593A1 (en) 2016-05-11 2017-11-16 Ge Healthcare Bioprocess R&D Ab Method of cleaning and/or sanitizing a separation matrix
US12448411B2 (en) 2016-09-30 2025-10-21 Cytiva Bioprocess R&D Ab Separation method
KR102578087B1 (ko) * 2017-08-17 2023-09-18 저스트-에보텍 바이오로직스, 아이엔씨. 숙주세포 갈렉틴(galectins) 및 다른 오염물(contaminant)로부터 글리코실화 단백질을 정제하는 방법
US20210130396A1 (en) * 2017-08-30 2021-05-06 Ares Trading S.A. Method for purifying proteins
US11952399B2 (en) * 2018-12-18 2024-04-09 Amgen Inc. Methods for purifying proteins
CA3127228A1 (en) * 2019-01-30 2020-08-06 Amgen Inc. Aflibercept attributes and methods of characterizing and modifying thereof
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
US20230357315A1 (en) * 2020-03-11 2023-11-09 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
WO2023053030A1 (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
JP2024539136A (ja) * 2021-10-19 2024-10-28 アルテオジェン・インコーポレイテッド IgG Fcドメインを有する融合タンパク質の精製方法
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
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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
JP2017521389A (ja) 2017-08-03
AU2015273049A1 (en) 2017-01-12
BR112016029157A2 (pt) 2017-08-22
CN106536565A (zh) 2017-03-22
RU2698654C2 (ru) 2019-08-28
EP3155009A1 (en) 2017-04-19
US10556942B2 (en) 2020-02-11
JP6747985B2 (ja) 2020-08-26
BR112016029157A8 (pt) 2021-07-06
MA40232A (fr) 2017-04-19
MX2016016318A (es) 2017-06-12
PH12016502482A1 (en) 2017-04-10
CA2951766A1 (en) 2015-12-17
RU2017100005A3 (enExample) 2019-02-28
RU2017100005A (ru) 2018-07-13
WO2015189832A1 (en) 2015-12-17
US20170152298A1 (en) 2017-06-01

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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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