CA2951766A1 - Process for the purification of tnfr:fc fusion protein - Google Patents

Process for the purification of tnfr:fc fusion protein Download PDF

Info

Publication number
CA2951766A1
CA2951766A1 CA2951766A CA2951766A CA2951766A1 CA 2951766 A1 CA2951766 A1 CA 2951766A1 CA 2951766 A CA2951766 A CA 2951766A CA 2951766 A CA2951766 A CA 2951766A CA 2951766 A1 CA2951766 A1 CA 2951766A1
Authority
CA
Canada
Prior art keywords
protein
tnfr
chromatography column
fusion protein
hcp
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Abandoned
Application number
CA2951766A
Other languages
English (en)
French (fr)
Inventor
Abir BANERJEE
Chandranath GANAPATHY
Rustom Sorab Mody
Ashok Mishra
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Lupin Atlantis Holdings SA
Original Assignee
Lupin Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Lupin Ltd filed Critical Lupin Ltd
Publication of CA2951766A1 publication Critical patent/CA2951766A1/en
Abandoned legal-status Critical Current

Links

Classifications

    • 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

Landscapes

  • 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)
CA2951766A 2014-06-13 2015-06-13 Process for the purification of tnfr:fc fusion protein Abandoned CA2951766A1 (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 (1)

Publication Number Publication Date
CA2951766A1 true CA2951766A1 (en) 2015-12-17

Family

ID=53524922

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2951766A Abandoned CA2951766A1 (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)

Families Citing this family (26)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
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
JP7106187B2 (ja) 2016-05-11 2022-07-26 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 分離マトリックスを保存する方法
ES2909833T3 (es) 2016-05-11 2022-05-10 Cytiva Bioprocess R & D Ab Método de limpieza y/o desinfección de una matriz de separación
ES2874974T3 (es) 2016-05-11 2021-11-05 Cytiva Bioprocess R & D Ab Matriz de separación
US10730908B2 (en) 2016-05-11 2020-08-04 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
US10703774B2 (en) 2016-09-30 2020-07-07 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
US12448411B2 (en) 2016-09-30 2025-10-21 Cytiva Bioprocess R&D Ab Separation method
ES2887046T3 (es) * 2017-08-17 2021-12-21 Just Evotec Biologics Inc Método de purificación de proteína glicosilada a partir de galectinas de las células hospedadoras y otros contaminantes
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
US20220098279A1 (en) * 2019-01-30 2022-03-31 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
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
EP4408879A4 (en) * 2021-09-28 2025-08-27 Kashiv Biosciences Llc IMPROVED PROCESS FOR PURIFYING FUSION PROTEIN
WO2023053030A1 (en) * 2021-09-28 2023-04-06 Kashiv Biosciences, Llc An improved process for purification of protein
WO2023068740A1 (ko) * 2021-10-19 2023-04-27 주식회사 알테오젠 Igg fc 도메인을 가지는 융합 단백질의 정제방법
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

Family Cites Families (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RU2021284C1 (ru) * 1991-05-30 1994-10-15 Всесоюзный научно-исследовательский институт технологии кровезаменителей и гормональных препаратов Способ очистки клинических фракций декстрана
US7294481B1 (en) 1999-01-05 2007-11-13 Immunex Corporation Method for producing recombinant proteins
SI1478394T1 (sl) 2002-02-27 2008-12-31 Immunex Corp STABILIZIRAN TNFR-Fc SESTAVEK Z ARGININOM
CA2516518A1 (en) 2003-02-28 2004-09-10 Lonza Biologics Plc. Antibody purification by protein a and ion exchange chromatography
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
JP2010501622A (ja) * 2006-08-28 2010-01-21 アレス トレーディング ソシエテ アノニム Ｆｃ−融合タンパク質の精製法
US8513393B2 (en) * 2006-08-28 2013-08-20 Ares Trading S.A. Process for the purification of Fc-containing proteins
EP2203465A1 (en) * 2007-10-22 2010-07-07 Merck Serono S.A. Method for purifying an fc-containing protein
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
CA2739352C (en) * 2008-10-29 2021-07-13 Wyeth Llc Methods for purification of single domain antigen binding molecules
KR101753569B1 (ko) * 2010-01-22 2017-07-04 베링거 인겔하임 인터내셔날 게엠베하 Ｆｃ―함유 단백질을 정제하는 크로마토그래피 방법
EP2723759A4 (en) * 2011-06-24 2015-01-28 Reddys Lab Ltd Dr PURIFICATION OF CHIMERIC PROTEIN
JP6280499B2 (ja) * 2011-07-08 2018-02-14 メルク・シャープ・アンド・ドーム・コーポレーションＭｅｒｃｋ Ｓｈａｒｐ ＆ Ｄｏｈｍｅ Ｃｏｒｐ． Ｆｃ融合タンパク質の精製方法
KR101454316B1 (ko) * 2011-08-17 2014-10-27 한화케미칼 주식회사 활성형 ＴＮＦＲ-Ｆｃ 융합 단백질을 제조하는 방법
US9249182B2 (en) 2012-05-24 2016-02-02 Abbvie, Inc. Purification of antibodies using hydrophobic interaction chromatography
AU2013315750B9 (en) 2012-09-11 2018-11-15 Coherus Biosciences, Inc. Correctly folded etanercept in high purity and excellent yield
CN102911250B (zh) * 2012-09-29 2014-04-16 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
US9649383B2 (en) * 2012-11-19 2017-05-16 Merck Sharp & Dohme Corp. Liquid formulations for TNFR:Fc fusion proteins
AU2014240596B2 (en) * 2013-03-14 2018-09-27 Amgen Inc. Removal of leaked affinity purification ligand
US8946395B1 (en) * 2013-10-18 2015-02-03 Abbvie Inc. Purification of proteins using hydrophobic interaction chromatography

Also Published As

Publication number Publication date
BR112016029157A2 (pt) 2017-08-22
BR112016029157A8 (pt) 2021-07-06
US10556942B2 (en) 2020-02-11
EP3155009A1 (en) 2017-04-19
AU2015273049A1 (en) 2017-01-12
MX2016016318A (es) 2017-06-12
JP2017521389A (ja) 2017-08-03
PH12016502482A1 (en) 2017-04-10
CN106536565A (zh) 2017-03-22
WO2015189832A1 (en) 2015-12-17
AU2015273049B2 (en) 2019-11-14
RU2698654C2 (ru) 2019-08-28
MA40232A (fr) 2017-04-19
US20170152298A1 (en) 2017-06-01
JP6747985B2 (ja) 2020-08-26
RU2017100005A (ru) 2018-07-13
RU2017100005A3 (enExample) 2019-02-28

Similar Documents

Publication Publication Date Title
AU2015273049B2 (en) Process for the purification of TNFR:Fc fusion protein
KR101683415B1 (ko) 단일클론항체에 대한 정제 방법
CN102712673B (zh) 用于纯化含fc的蛋白的色谱方法
EP2791176B1 (en) A method of antibody purification
CN105777904B (zh) 抗TNFα类单克隆抗体的阳离子交换色谱纯化方法
EP2729482B1 (en) Method for purifying fc-fusion protein
CN113710685B (zh) 通过使用捕获前的絮凝改善免疫球蛋白的亲和色谱
NZ574623A (en) Process for the purification of fc-fusion proteins
CA2673771A1 (en) Process for the purification of fc-containing proteins
CN102911250B (zh) 酸性重组蛋白药物的纯化方法
JP7817743B2 (ja) タンパク質の精製の改善されたプロセス
JP2023139142A (ja) 眼科用タンパク質医薬品の精製方法（Ｒｅｆｉｎｉｎｇ ｍｅｔｈｏｄ ｏｆ ｏｐｈｔｈａｌｍｉｃ ｐｒｏｔｅｉｎ ｐｈａｒｍａｃｅｕｔｉｃａｌｓ）
AU2022357575A1 (en) An improved process for purification of protein
NZ574626A (en) Process for removing free Fc-moieties from fluids comprising Fc-containing proteins using ion exchange chromatography
CA3182314A1 (en) An improved process of purification of protein
CN105777903B (zh) 一种阿达木单抗的阳离子交换色谱纯化方法
KR20070091098A (ko) 단백질 분리 방법
WO2022234412A1 (en) A process for purification of fc-fusion proteins
WO2025219869A1 (en) Methods of purifying immunoglobulins comprising n-terminal glutamine
HK1174044B (en) Chromatographic method for purifying fc-containing proteins

Legal Events

Date Code Title Description
EEER Examination request

Effective date: 20200602

FZDE Discontinued

Effective date: 20220920