BR112016029157A2 - processo para purificar a proteína de fusão tnfr:fc - Google Patents

processo para purificar a proteína de fusão tnfr:fc

Info

Publication number
BR112016029157A2
BR112016029157A2 BR112016029157A BR112016029157A BR112016029157A2 BR 112016029157 A2 BR112016029157 A2 BR 112016029157A2 BR 112016029157 A BR112016029157 A BR 112016029157A BR 112016029157 A BR112016029157 A BR 112016029157A BR 112016029157 A2 BR112016029157 A2 BR 112016029157A2
Authority
BR
Brazil
Prior art keywords
fusion protein
tnfr
purify
present
hcp
Prior art date
Application number
BR112016029157A
Other languages
English (en)
Other versions
BR112016029157A8 (pt
Inventor
Banerjee Abir
Mishra Ashok
Ganapathy Chandranath
Rustom Mody Sorab
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 BR112016029157A2 publication Critical patent/BR112016029157A2/pt
Publication of BR112016029157A8 publication Critical patent/BR112016029157A8/pt

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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
    • 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 - B01D15/36
    • B01D15/3804—Affinity chromatography
    • B01D15/3809—Affinity chromatography of the antigen-antibody type, e.g. protein A, G, 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 - B01D15/36
    • 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)

Abstract

a presente invenção refere-se à purificação da proteína de fusão tnfr:fc. mais especificamente refere-se ao processo de purificação da proteína de fusão tnfr:fc em que a hcp é reduzida. a presente invenção refere-se à utilização de cromatografia em modo misto e/ou cromatografia por afinidade para produzir proteína de fusão tnfr: fc que está substancialmente isenta de pelo menos uma das enzimas degradadoras de proteínas presentes na hcp.
BR112016029157A 2014-06-13 2015-06-13 processo para purificar a proteína de fusão tnfr:fc BR112016029157A8 (pt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
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
BR112016029157A2 true BR112016029157A2 (pt) 2017-08-22
BR112016029157A8 BR112016029157A8 (pt) 2021-07-06

Family

ID=53524922

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112016029157A BR112016029157A8 (pt) 2014-06-13 2015-06-13 processo para purificar a proteína de fusão tnfr:fc

Country Status (12)

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

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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
WO2017194597A1 (en) 2016-05-11 2017-11-16 Ge Healthcare Bioprocess R&D Ab Separation matrix
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
US10889615B2 (en) 2016-05-11 2021-01-12 Cytiva Bioprocess R&D Ab Mutated immunoglobulin-binding polypeptides
EP3455241B1 (en) 2016-05-11 2022-02-23 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
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
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
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
WO2023095665A1 (ja) * 2021-11-29 2023-06-01 東ソー株式会社 抗体の分離方法

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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
US20030180287A1 (en) 2002-02-27 2003-09-25 Immunex Corporation Polypeptide formulation
WO2004076485A1 (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
WO2008025748A1 (en) * 2006-08-28 2008-03-06 Ares Trading S.A. Process for the purification of fc-containing proteins
AU2008314689A1 (en) * 2007-10-22 2009-04-30 Merck Serono S.A. Method for purifying an Fc-containing protein
KR20100128315A (ko) * 2008-02-29 2010-12-07 바이오겐 아이덱 엠에이 인코포레이티드 정제된 면역글로불린 융합 단백질 및 그의 정제 방법
KR20110079693A (ko) * 2008-10-29 2011-07-07 와이어쓰 엘엘씨 단일 도메인 항원 결합 분자의 정제 방법
KR101753569B1 (ko) * 2010-01-22 2017-07-04 베링거 인겔하임 인터내셔날 게엠베하 Ｆｃ―함유 단백질을 정제하는 크로마토그래피 방법
US20140128577A1 (en) * 2011-06-24 2014-05-08 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
EP2753634B1 (en) * 2011-08-17 2017-11-01 Ares Trading S.A. Method for preparing active form of tnfr-fc fusion protein
US9249182B2 (en) 2012-05-24 2016-02-02 Abbvie, Inc. Purification of antibodies using hydrophobic interaction chromatography
DK2895188T3 (en) * 2012-09-11 2018-02-26 Coherus Biosciences Inc CORRECTLY FOLDED ETHNECCEPT 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
EP2919812A4 (en) * 2012-11-19 2016-05-18 Merck Sharp & Dohme Liquid formulations for TNFR: FC fusion proteins
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US8946395B1 (en) * 2013-10-18 2015-02-03 Abbvie Inc. Purification of proteins using hydrophobic interaction chromatography

Also Published As

Publication number Publication date
AU2015273049A1 (en) 2017-01-12
RU2017100005A (ru) 2018-07-13
RU2698654C2 (ru) 2019-08-28
MA40232A (fr) 2017-04-19
EP3155009A1 (en) 2017-04-19
AU2015273049B2 (en) 2019-11-14
CN106536565A (zh) 2017-03-22
RU2017100005A3 (pt) 2019-02-28
JP6747985B2 (ja) 2020-08-26
PH12016502482A1 (en) 2017-04-10
US10556942B2 (en) 2020-02-11
BR112016029157A8 (pt) 2021-07-06
US20170152298A1 (en) 2017-06-01
CA2951766A1 (en) 2015-12-17
JP2017521389A (ja) 2017-08-03
MX2016016318A (es) 2017-06-12
WO2015189832A1 (en) 2015-12-17

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B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]

Free format text: DE ACORDO COM O ARTIGO 229-C DA LEI NAO 10196/2001, QUE MODIFICOU A LEI NAO 9279/96, A CONCESSAO DA PATENTE ESTA CONDICIONADA A ANUAANCIA PRA VIA DA ANVISA. CONSIDERANDO A APROVAA AO DOS TERMOS DO PARECER NAO 337/PGF/EA/2010, BEM COMO A PORTARIA INTERMINISTERIAL NAO 1065 DE 24/05/2012, ENCAMINHA-SE O PRESENTE PEDIDO PARA AS PROVIDAANCIAS CABA-VEIS.

B07G Grant request does not fulfill article 229-c lpi (prior consent of anvisa) [chapter 7.7 patent gazette]

Free format text: NOTIFICACAO DE DEVOLUCAO DO PEDIDO EM FUNCAO DA REVOGACAO DO ART. 229-C DA LEI NO 9.279, DE 1996, POR FORCA DA LEI NO 14.195, DE 2021

B06U Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]
B11B Dismissal acc. art. 36, par 1 of ipl - no reply within 90 days to fullfil the necessary requirements