JP6747985B2 - TNFR:Fc融合タンパク質の精製方法 - Google Patents

TNFR:Fc融合タンパク質の精製方法 Download PDF

Info

Publication number
JP6747985B2
JP6747985B2 JP2016572703A JP2016572703A JP6747985B2 JP 6747985 B2 JP6747985 B2 JP 6747985B2 JP 2016572703 A JP2016572703 A JP 2016572703A JP 2016572703 A JP2016572703 A JP 2016572703A JP 6747985 B2 JP6747985 B2 JP 6747985B2
Authority
JP
Japan
Prior art keywords
protein
tnfr
fusion protein
column
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.)
Expired - Fee Related
Application number
JP2016572703A
Other languages
English (en)
Japanese (ja)
Other versions
JP2017521389A (ja
JP2017521389A5 (OSRAM
Inventor
バナージー,アビール
ガナパシー,チャンドラナス
モディ,ラストム,ソラブ
ミシュラ,アショク
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 Atlantis Holdings SA
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 Atlantis Holdings SA filed Critical Lupin Atlantis Holdings SA
Publication of JP2017521389A publication Critical patent/JP2017521389A/ja
Publication of JP2017521389A5 publication Critical patent/JP2017521389A5/ja
Application granted granted Critical
Publication of JP6747985B2 publication Critical patent/JP6747985B2/ja
Expired - Fee Related legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • 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
    • 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
    • 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
    • C07K14/715Receptors; 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

Landscapes

  • 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)
JP2016572703A 2014-06-13 2015-06-13 TNFR:Fc融合タンパク質の精製方法 Expired - Fee Related JP6747985B2 (ja)

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 (3)

Publication Number Publication Date
JP2017521389A JP2017521389A (ja) 2017-08-03
JP2017521389A5 JP2017521389A5 (OSRAM) 2018-07-19
JP6747985B2 true JP6747985B2 (ja) 2020-08-26

Family

ID=53524922

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2016572703A Expired - Fee Related JP6747985B2 (ja) 2014-06-13 2015-06-13 TNFR:Fc融合タンパク質の精製方法

Country Status (12)

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

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
US11753438B2 (en) 2016-05-11 2023-09-12 Cytiva Bioprocess R&D Ab Method of cleaning and/or sanitizing a separation matrix
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
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
US10513537B2 (en) 2016-05-11 2019-12-24 Ge Healthcare Bioprocess R&D Ab Separation matrix
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
US12448411B2 (en) 2016-09-30 2025-10-21 Cytiva Bioprocess R&D Ab Separation method
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
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
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
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
CA3233422A1 (en) * 2021-09-28 2023-04-06 Kashiv Biosciences, Llc An improved process for purification of fusion protein
CA3235508A1 (en) * 2021-10-19 2023-05-11 Soon Jae Park Method for purifying fusion protein having 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

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
PL215168B1 (pl) 2002-02-27 2013-10-31 Immunex Corp Formulacja polipeptydowa
EP1601697B1 (en) 2003-02-28 2007-05-30 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
PL2061803T5 (pl) * 2006-08-28 2023-03-27 Ares Trading S.A. Proces oczyszczania białek zawierających fc
AU2008314689A1 (en) * 2007-10-22 2009-04-30 Merck Serono S.A. Method for purifying an Fc-containing protein
US20110129468A1 (en) * 2008-02-29 2011-06-02 Biogen Idec Ma Inc. Purified immunoglobulin fusion proteins and methods of their purification
CA2739352C (en) * 2008-10-29 2021-07-13 Wyeth Llc Methods for purification of single domain antigen binding molecules
JP5567691B2 (ja) * 2010-01-22 2014-08-06 ベーリンガー インゲルハイム インターナショナル ゲゼルシャフト ミット ベシュレンクテル ハフツング Fc含有タンパク質を精製するためのクロマトグラフィー法
WO2012176158A1 (en) * 2011-06-24 2012-12-27 Dr. Reddy's Laboratories Limited Purification of chimeric protein
CA2840951A1 (en) * 2011-07-08 2013-01-17 Merck Sharp & Dohme Corp. Methods for purifying fc-fusion protein
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
SG11201501460RA (en) * 2012-09-11 2015-04-29 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
WO2014078627A1 (en) * 2012-11-19 2014-05-22 Merck Sharp & Dohme Corp. Liquid formulations for tnfr:fc fusion proteins
SI2969099T2 (sl) * 2013-03-14 2022-04-29 Amgen Inc. Odstranjevanje izluženega afinitetnega purifikacijskega liganda
US8946395B1 (en) * 2013-10-18 2015-02-03 Abbvie Inc. Purification of proteins using hydrophobic interaction chromatography

Also Published As

Publication number Publication date
CN106536565A (zh) 2017-03-22
PH12016502482A1 (en) 2017-04-10
RU2698654C2 (ru) 2019-08-28
WO2015189832A1 (en) 2015-12-17
CA2951766A1 (en) 2015-12-17
AU2015273049A1 (en) 2017-01-12
BR112016029157A8 (pt) 2021-07-06
RU2017100005A (ru) 2018-07-13
BR112016029157A2 (pt) 2017-08-22
EP3155009A1 (en) 2017-04-19
AU2015273049B2 (en) 2019-11-14
JP2017521389A (ja) 2017-08-03
US20170152298A1 (en) 2017-06-01
US10556942B2 (en) 2020-02-11
RU2017100005A3 (OSRAM) 2019-02-28
MX2016016318A (es) 2017-06-12
MA40232A (fr) 2017-04-19

Similar Documents

Publication Publication Date Title
JP6747985B2 (ja) TNFR:Fc融合タンパク質の精製方法
KR101683415B1 (ko) 단일클론항체에 대한 정제 방법
CN102712673B (zh) 用于纯化含fc的蛋白的色谱方法
JP5873016B2 (ja) アミノ酸を利用したタンパク質の精製方法
US20140288278A1 (en) Chromatography process for resolving heterogeneous antibody aggregates
RU2590726C2 (ru) Способ очистки витамин к-зависимых белков, таких как коагуляционный фактор ix
JP6151640B2 (ja) たん白質の精製方法
US20030166869A1 (en) Methods for purifying 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
EP2695889A1 (en) Protein purification by ion exchange
KR20110139216A (ko) 소형 모듈형 면역약제 단백질의 정제 방법
NZ574623A (en) Process for the purification of fc-fusion proteins
CN105121469A (zh) 用于增加蛋白质的焦谷氨酸形成的方法
JP7458980B2 (ja) アルキルグリコシドによるタンパク質精製およびウイルス不活化
CN105777904A (zh) 抗TNFα类单克隆抗体的阳离子交换色谱纯化方法
CN102911250B (zh) 酸性重组蛋白药物的纯化方法
JP2023139142A (ja) 眼科用タンパク質医薬品の精製方法(Refining method of ophthalmic protein pharmaceuticals)
JP2023523823A (ja) タンパク質の精製の改善されたプロセス
CN111849945A (zh) 人凝血因子VIIa的纯化方法
CN109929038B (zh) Vegf捕获剂融合蛋白的纯化方法
CN106148302A (zh) 一种重组蛋白质的纯化方法
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
Yoshimoto et al. Large scale purification of isoinhibitors of trypsin from swine colostrum using zinc chelate chromatography and chromatofocusing
WO2025219869A1 (en) Methods of purifying immunoglobulins comprising n-terminal glutamine

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20170511

A711 Notification of change in applicant

Free format text: JAPANESE INTERMEDIATE CODE: A711

Effective date: 20170621

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A821

Effective date: 20170621

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20180605

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20180605

A977 Report on retrieval

Free format text: JAPANESE INTERMEDIATE CODE: A971007

Effective date: 20190424

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20190514

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20190809

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20200114

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20200410

TRDD Decision of grant or rejection written
A01 Written decision to grant a patent or to grant a registration (utility model)

Free format text: JAPANESE INTERMEDIATE CODE: A01

Effective date: 20200714

A61 First payment of annual fees (during grant procedure)

Free format text: JAPANESE INTERMEDIATE CODE: A61

Effective date: 20200806

R150 Certificate of patent or registration of utility model

Ref document number: 6747985

Country of ref document: JP

Free format text: JAPANESE INTERMEDIATE CODE: R150

LAPS Cancellation because of no payment of annual fees