BR112012024550A2 - processo para purificação de proteínas dependentes de vitamina k tal como o fator de coagulação ix - Google Patents

processo para purificação de proteínas dependentes de vitamina k tal como o fator de coagulação ix

Info

Publication number
BR112012024550A2
BR112012024550A2 BR112012024550A BR112012024550A BR112012024550A2 BR 112012024550 A2 BR112012024550 A2 BR 112012024550A2 BR 112012024550 A BR112012024550 A BR 112012024550A BR 112012024550 A BR112012024550 A BR 112012024550A BR 112012024550 A2 BR112012024550 A2 BR 112012024550A2
Authority
BR
Brazil
Prior art keywords
vitamin
dependent protein
dependent
coagulation factor
resin
Prior art date
Application number
BR112012024550A
Other languages
English (en)
Other versions
BR112012024550B1 (pt
Inventor
Gustav Gilljam
Stefan Winge
Original Assignee
Octapharma Ag
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 Octapharma Ag filed Critical Octapharma Ag
Publication of BR112012024550A2 publication Critical patent/BR112012024550A2/pt
Publication of BR112012024550B1 publication Critical patent/BR112012024550B1/pt

Links

Classifications

    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K1/00General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14Extraction; Separation; Purification
    • C07K1/16Extraction; Separation; Purification by chromatography
    • C07K1/22Affinity chromatography or related techniques based upon selective absorption processes
    • 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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K1/00General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14Extraction; Separation; Purification
    • C07K1/16Extraction; Separation; Purification by chromatography
    • 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
    • C07K14/745Blood coagulation or fibrinolysis factors
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/14Hydrolases (3)
    • C12N9/48Hydrolases (3) acting on peptide bonds (3.4)
    • C12N9/50Proteinases, e.g. Endopeptidases (3.4.21-3.4.25)
    • C12N9/64Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/14Hydrolases (3)
    • C12N9/48Hydrolases (3) acting on peptide bonds (3.4)
    • C12N9/50Proteinases, e.g. Endopeptidases (3.4.21-3.4.25)
    • C12N9/64Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue
    • C12N9/6421Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue from mammals
    • C12N9/6424Serine endopeptidases (3.4.21)
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/14Hydrolases (3)
    • C12N9/48Hydrolases (3) acting on peptide bonds (3.4)
    • C12N9/50Proteinases, e.g. Endopeptidases (3.4.21-3.4.25)
    • C12N9/64Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue
    • C12N9/6421Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue from mammals
    • C12N9/6424Serine endopeptidases (3.4.21)
    • C12N9/644Coagulation factor IXa (3.4.21.22)

Landscapes

  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Organic Chemistry (AREA)
  • Genetics & Genomics (AREA)
  • Engineering & Computer Science (AREA)
  • Zoology (AREA)
  • Biochemistry (AREA)
  • Medicinal Chemistry (AREA)
  • Molecular Biology (AREA)
  • General Health & Medical Sciences (AREA)
  • Wood Science & Technology (AREA)
  • Biomedical Technology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biophysics (AREA)
  • General Engineering & Computer Science (AREA)
  • Biotechnology (AREA)
  • Microbiology (AREA)
  • Analytical Chemistry (AREA)
  • Hematology (AREA)
  • Toxicology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Solid-Sorbent Or Filter-Aiding Compositions (AREA)

Abstract

processo para purificação de proteínas dependentes de vitamina k tal como o fator de coagulação ix. processo de produção de uma proteína dependente de vitamina k livre de príons em uma sequência de purificação que emprega cromatografia caracterizado pelo fato de que - pelo menos uma etapa de cromatografia é realizada utilizando uma resina multimodal - fornecimento de uma fração que contém proteína dependente de vitamina k em uma solução aquosa; - contato da fração que contém a proteína dependente de vitamina k com uma resina multimodal em um ph entre 6-9; - opcionalmente lavagem da resina multimodal que possui a proteína dependente de vitamina k adsorvida com um tampãp de lavagem aquoso para lavar contaminantes e reter a proteína dependente de vitamina k, antes da proteína dependente de vitamina k ser eluída; - a proteína dependente de vitamina k é eluída da resina multi-modal em um ph entre 6 até 9 em um tampão que compreende arginina; e - opcionalmente coleta de frações que contêm proteína dependente de vitamina k na forma purificada ou enriquecida.
BR112012024550-3A 2010-03-30 2011-03-30 processo de produção de uma proteína dependente de vitamina k livre de príons em uma sequência de purificação que emprega cromatografia BR112012024550B1 (pt)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
EP10158511.5 2010-03-30
EP10158511 2010-03-30
US28289510P 2010-04-16 2010-04-16
US61/282,895 2010-04-16
PCT/EP2011/054906 WO2011121020A1 (en) 2010-03-30 2011-03-30 A process for purifying vitamin k dependent proteins such as coagulation factor ix

Publications (2)

Publication Number Publication Date
BR112012024550A2 true BR112012024550A2 (pt) 2015-09-22
BR112012024550B1 BR112012024550B1 (pt) 2020-12-08

Family

ID=42154362

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112012024550-3A BR112012024550B1 (pt) 2010-03-30 2011-03-30 processo de produção de uma proteína dependente de vitamina k livre de príons em uma sequência de purificação que emprega cromatografia

Country Status (16)

Country Link
US (1) US20130079498A1 (pt)
EP (2) EP2553095B1 (pt)
JP (1) JP5876868B2 (pt)
KR (1) KR101829860B1 (pt)
CN (1) CN102858971B (pt)
AU (2) AU2011234521B2 (pt)
BR (1) BR112012024550B1 (pt)
CA (1) CA2793136C (pt)
DK (2) DK2553095T3 (pt)
ES (2) ES2740825T3 (pt)
IL (2) IL221609A (pt)
MX (1) MX2012011066A (pt)
RU (2) RU2731720C2 (pt)
TR (1) TR201911082T4 (pt)
WO (1) WO2011121020A1 (pt)
ZA (1) ZA201207227B (pt)

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105777862A (zh) 2012-10-24 2016-07-20 建新公司 使用mes和mops作为流动相改性剂从多峰树脂洗脱生物分子
CN105175486A (zh) * 2015-10-20 2015-12-23 上海洲跃生物科技有限公司 一种高纯人凝血因子ix的制备方法
CN105330736A (zh) * 2015-11-06 2016-02-17 上海洲跃生物科技有限公司 一种从去冷胶血浆中同时制备人凝血因子ix及vii的方法
CN105326859A (zh) * 2015-11-09 2016-02-17 上海洲跃生物科技有限公司 一种从Cohn血浆组分III中制备人凝血酶原复合物的方法
WO2018187388A1 (en) * 2017-04-04 2018-10-11 Scarab Genomics, Llc Improved purification of crm 197 from bacteria
CN107460182B (zh) * 2017-09-01 2020-12-18 上海太阳生物技术有限公司 一种制备活化猪血浆凝血因子x的方法
CN109444422A (zh) * 2018-12-17 2019-03-08 福建省立医院 一种基于upt-lf定量测定血清pivka-ii的检测卡及其构建方法及应用
CN111378029B (zh) * 2018-12-29 2023-05-05 四川远大蜀阳药业有限责任公司 一种人凝血因子ix的制备方法
CN110257358B (zh) * 2019-06-10 2023-05-19 广东双林生物制药有限公司 一种高纯人凝血因子ix制剂的生产方法
CN111925450B (zh) * 2020-09-21 2020-12-15 迈威(上海)生物科技股份有限公司 一种去除毕赤酵母表达重组蛋白聚集体和/或降解片段的方法
CN113267390B (zh) * 2021-05-11 2023-05-05 北京丹大生物技术有限公司 一种用于滤纸干血片的检测标志物洗脱液及其应用
CA3233419A1 (en) * 2021-09-28 2023-04-06 Kashiv Biosciences, Llc An improved process for purification of protein

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US4540573A (en) 1983-07-14 1985-09-10 New York Blood Center, Inc. Undenatured virus-free biologically active protein derivatives
DK162233C (da) * 1989-11-09 1992-03-16 Novo Nordisk As Fremgangsmaade til isolering af faktor viii fra blodplasma og pharmaceutisk praeparat indeholdende den saaledes isolerede fator viii
CA2105282C (en) * 1991-03-01 2002-09-24 Centeon L.L.C. Preparation of factor ix
US5286849A (en) * 1992-07-14 1994-02-15 Alpha Therapeutic Corporation Purification of factor IX
DE19506633A1 (de) * 1995-02-25 1996-08-29 Octapharma Ag Verfahren zur Herstellung von Faktor IX aus biologischen Quellen
US5714583A (en) * 1995-06-07 1998-02-03 Genetics Institute, Inc. Factor IX purification methods
AU766551C (en) * 1998-08-28 2005-02-17 Genentech Inc. Human anti-factor IX/IXa antibodies
RU2321633C2 (ru) * 2001-02-16 2008-04-10 Ново Нордиск Хелт Кэр Аг Способ получения витамин к-зависимых белков
SE0203551D0 (sv) * 2002-12-02 2002-12-02 Biovitrum Ab Prothrombin purification
US20040106779A1 (en) * 2002-12-03 2004-06-03 Bigler Douglas E. Modified factor IX preparation
US7750129B2 (en) 2004-02-27 2010-07-06 Ge Healthcare Bio-Sciences Ab Process for the purification of antibodies
AU2005252296B2 (en) 2004-06-07 2009-08-20 Evolve Biologics Inc. Isolation of plasma or serum proteins
MXPA06014318A (es) * 2004-06-07 2007-08-02 Avt Plasma Ltd Proceso para aislamiento de proteinas.
WO2006067230A1 (en) * 2004-12-23 2006-06-29 Novo Nordisk Health Care Ag Reduction of the content of protein contaminants in compositions comprising a vitamin k-dependent protein of interest
EP1707634A1 (en) * 2005-03-29 2006-10-04 Octapharma AG Method for isolation of recombinantly produced proteins
EP1739179A1 (en) 2005-06-30 2007-01-03 Octapharma AG Serum-free stable transfection and production of recombinant human proteins in human cell lines
ES2364118T3 (es) 2007-07-11 2011-08-25 Novo Nordisk A/S Purificación de factor viii usando una resina de modo mixto o multimodal.
EP2027875A1 (en) 2007-08-23 2009-02-25 Octapharma AG A Process for Isolation and Purification of a Target Protein free of Prion Protein (PrPSC)
ES2538706T3 (es) * 2008-06-24 2015-06-23 Octapharma Ag Procedimiento de purificación del factor de coagulación VIII

Also Published As

Publication number Publication date
CA2793136C (en) 2019-05-07
MX2012011066A (es) 2012-10-10
RU2731720C2 (ru) 2020-09-08
CN102858971A (zh) 2013-01-02
ES2740825T3 (es) 2020-02-06
JP5876868B2 (ja) 2016-03-02
EP2553095B1 (en) 2016-10-12
IL248549A0 (en) 2016-12-29
AU2015203388A1 (en) 2015-07-09
US20130079498A1 (en) 2013-03-28
DK2553095T3 (en) 2017-01-23
ZA201207227B (en) 2013-06-26
EP3133157A1 (en) 2017-02-22
JP2013523689A (ja) 2013-06-17
AU2011234521A1 (en) 2012-09-13
AU2011234521B2 (en) 2015-04-23
ES2610529T3 (es) 2017-04-28
KR101829860B1 (ko) 2018-02-19
KR20130010474A (ko) 2013-01-28
EP2553095A1 (en) 2013-02-06
IL221609A (en) 2017-01-31
RU2016122883A (ru) 2018-11-29
RU2016122883A3 (pt) 2019-12-03
CN102858971B (zh) 2016-06-01
WO2011121020A1 (en) 2011-10-06
CA2793136A1 (en) 2011-10-06
EP3133157B1 (en) 2019-05-08
TR201911082T4 (tr) 2019-08-21
RU2012146084A (ru) 2014-05-10
AU2015203388B2 (en) 2017-11-16
RU2590726C2 (ru) 2016-07-10
BR112012024550B1 (pt) 2020-12-08
DK3133157T3 (da) 2019-08-12
IL248549B (en) 2020-06-30

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B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B06T Formal requirements before examination [chapter 6.20 patent gazette]
B06G Technical and formal requirements: other requirements [chapter 6.7 patent gazette]
B06A Patent application procedure suspended [chapter 6.1 patent gazette]
B09A Decision: intention to grant [chapter 9.1 patent gazette]
B16A Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]

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