AU2009264282B2 - A process of purifying coagulation factor VIII - Google Patents

A process of purifying coagulation factor VIII Download PDF

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Publication number
AU2009264282B2
AU2009264282B2 AU2009264282A AU2009264282A AU2009264282B2 AU 2009264282 B2 AU2009264282 B2 AU 2009264282B2 AU 2009264282 A AU2009264282 A AU 2009264282A AU 2009264282 A AU2009264282 A AU 2009264282A AU 2009264282 B2 AU2009264282 B2 AU 2009264282B2
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Prior art keywords
fviii
resin
buffer
chromatography
elution
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AU2009264282A
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AU2009264282A1 (en
Inventor
Carin Borgvall
Ulrika Ericsson
Gustav Gilljam
Mats Jernberg
Stefan Winge
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Octapharma AG
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Octapharma AG
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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14—Extraction; Separation; Purification
    • C07K1/16—Extraction; Separation; Purification by chromatography
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/36—Blood coagulation or fibrinolysis factors
    • A61K38/37—Factors VIII
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/55—Protease inhibitors
    • A61K38/57—Protease inhibitors from animals; from humans
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14—Extraction; Separation; Purification
    • C07K1/36—Extraction; Separation; Purification by a combination of two or more processes of different types
    • 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
    • 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
    • C07K14/745—Blood coagulation or fibrinolysis factors
    • 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
    • C07K14/745—Blood coagulation or fibrinolysis factors
    • C07K14/755—Factors VIII, e.g. factor VIII C (AHF), factor VIII Ag (VWF)
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/14—Hydrolases (3)
    • C12N9/48—Hydrolases (3) acting on peptide bonds (3.4)
    • C12N9/50—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25)
    • C12N9/64—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue
    • C12N9/6421—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue from mammals
    • C12N9/6424—Serine endopeptidases (3.4.21)
    • C12N9/647—Blood coagulation factors not provided for in a preceding group or according to more than one of the proceeding groups

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Zoology (AREA)
  • Genetics & Genomics (AREA)
  • Engineering & Computer Science (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Hematology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biophysics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Immunology (AREA)
  • Toxicology (AREA)
  • Analytical Chemistry (AREA)
  • Biomedical Technology (AREA)
  • Wood Science & Technology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biotechnology (AREA)
  • Microbiology (AREA)
  • General Engineering & Computer Science (AREA)
  • Peptides Or Proteins (AREA)
AU2009264282A 2008-06-24 2009-06-24 A process of purifying coagulation factor VIII Active AU2009264282B2 (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US12940208P 2008-06-24 2008-06-24
US61/129,402 2008-06-24
EP08158893.1 2008-06-24
EP08158893 2008-06-24
PCT/EP2009/057883 WO2009156430A1 (en) 2008-06-24 2009-06-24 A process of purifying coagulation factor viii

Publications (2)

Publication Number Publication Date
AU2009264282A1 AU2009264282A1 (en) 2009-12-30
AU2009264282B2 true AU2009264282B2 (en) 2013-04-18

Family

ID=40076764

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2009264282A Active AU2009264282B2 (en) 2008-06-24 2009-06-24 A process of purifying coagulation factor VIII

Country Status (19)

Country Link
US (1) US8329871B2 (enExample)
EP (2) EP2300497B1 (enExample)
JP (1) JP5619738B2 (enExample)
KR (3) KR101700722B1 (enExample)
CN (1) CN102066417B (enExample)
AU (1) AU2009264282B2 (enExample)
BR (1) BRPI0914695B1 (enExample)
CA (1) CA2728047C (enExample)
DK (2) DK2300497T3 (enExample)
ES (2) ES2538706T3 (enExample)
IL (3) IL209758A (enExample)
MX (1) MX2010013908A (enExample)
PL (1) PL2300497T3 (enExample)
PT (1) PT2300497E (enExample)
RU (2) RU2567811C2 (enExample)
SI (1) SI2300497T1 (enExample)
UA (1) UA100901C2 (enExample)
WO (1) WO2009156430A1 (enExample)
ZA (1) ZA201009162B (enExample)

Families Citing this family (42)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
BRPI0814220B8 (pt) 2007-07-11 2021-05-25 Novo Nordisk As purificação de fator viii usando uma resina multimodal ou de modo misto
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)
WO2010020690A1 (en) 2008-08-21 2010-02-25 Octapharma Ag Recombinantly produced human factor viii and ix
KR101691070B1 (ko) * 2008-09-03 2016-12-29 옥타파마 아게 재조합에 의해 제조된 인자 ⅷ을 위한 신규한 보호 조성물
WO2010030222A1 (en) * 2008-09-12 2010-03-18 Ge Healthcare Bio-Sciences Ab Enhanced protein aggregate removal with multimodal anion exchangers in the presence of protein-excluded zwitterions
EP2552948B1 (en) * 2010-03-30 2016-07-13 Octapharma AG Process for the purification of growth factor protein g-csf
CN102858971B (zh) * 2010-03-30 2016-06-01 奥克塔法马股份有限公司 纯化维生素k依赖性蛋白如凝血因子ix的方法
CA2796729C (en) 2010-04-20 2020-06-23 Octapharma Ag Melezitose for stabilizing human blood plasma proteins
WO2012049285A1 (en) 2010-10-14 2012-04-19 Octapharma Ag A method for the quantitative glycosylation analysis of proteins
WO2012059495A1 (en) * 2010-11-05 2012-05-10 F. Hoffmann-La Roche Ag Optimized method for antibody capturing by mixed mode chromatography
RU2600886C2 (ru) * 2011-05-13 2016-10-27 Октафарма Аг Способ повышения продуктивности эукариотических клеток в продуцировании рекомбинантного fviii
WO2012173260A1 (ja) 2011-06-17 2012-12-20 学校法人東日本学園・北海道医療大学 ループスアンチコアグラント検出用血液凝固時間の測定方法
EP2771358A4 (en) * 2011-10-26 2015-08-26 Bio Rad Laboratories ELIMINATION OF VIRAL AGENTS IN MIXED MODE CHROMATOGRAPHY
MX379269B (es) * 2012-10-24 2025-03-11 Genzyme Corp Elucion de biomoleculas de resinas multimodales utilizando mes y mops como modificadores de fase movil.
US10188965B2 (en) 2012-12-05 2019-01-29 Csl Behring Gmbh Hydrophobic charge induction chromatographic depletion of a protein from a solution
US20140154233A1 (en) 2012-12-05 2014-06-05 Csl Limited Method of purifying therapeutic proteins
CN103880947B (zh) * 2012-12-21 2016-01-13 武汉禾元生物科技股份有限公司 一种分离纯化高纯度重组人血清白蛋白的层析方法
AU2014226126B2 (en) * 2013-03-08 2019-02-14 Genzyme Corporation Continuous purification of therapeutic proteins
WO2014201400A2 (en) * 2013-06-13 2014-12-18 Biogen Idec Ma Inc. Anti-factor viii antibodies or uses thereof
US10519194B2 (en) 2013-07-12 2019-12-31 Merck Patent Gmbh Removal of fragments from a sample containing a target protein using activated carbon
EP3875106A1 (en) * 2013-08-08 2021-09-08 Bioverativ Therapeutics Inc. Purification of chimeric fviii molecules
CN112195169A (zh) 2013-09-24 2021-01-08 辉瑞大药厂 包含重组人凝血因子Xa蛋白的异质性群体的组合物
TWI709569B (zh) 2014-01-17 2020-11-11 美商健臻公司 無菌層析樹脂及其用於製造方法的用途
TWI709570B (zh) * 2014-01-17 2020-11-11 美商健臻公司 無菌層析法及製法
WO2015107222A1 (en) * 2014-01-20 2015-07-23 Octapharma Ag A process for manufacturing factor viii having an improved ratio of fviii:c/fviii:ag
DK3461891T3 (da) * 2014-01-24 2020-08-10 Am-Pharma Bv Nedstrømsbehandling af en alkalisk phosphatase
NZ722391A (en) * 2014-02-04 2022-12-23 Biogen Ma Inc Use of cation-exchange chromatography in the flow-through mode to enrich post-translational modifications
CN104861060A (zh) * 2014-02-21 2015-08-26 神州细胞工程有限公司 一种纯化凝血因子viii的方法
WO2015183183A1 (en) 2014-05-29 2015-12-03 Agency For Science, Technology And Research Protein Extraction Methods
US10626164B2 (en) * 2014-07-25 2020-04-21 Csl Limited Purification of VWF
GB201506117D0 (en) 2015-04-10 2015-05-27 Ge Healthcare Bio Sciences Ab Method for chromatography
GB201506113D0 (en) 2015-04-10 2015-05-27 Ge Healthcare Bio Sciences Ab Method for chromatography
WO2016207328A1 (en) * 2015-06-24 2016-12-29 Glycotope Gmbh PROCESS FOR THE PURIFICATION OF γ-CARBOXYLATED POLYPEPTIDES
EP3205665A1 (en) 2016-02-11 2017-08-16 Octapharma AG Method of separating factor viii from blood products
GB201617240D0 (en) * 2016-10-11 2016-11-23 Profactor Pharma Ltd Purification process
EP3642225A1 (en) * 2017-06-23 2020-04-29 Baxalta Incorporated Purification of factor viii subspecies
CN107226859B (zh) * 2017-08-10 2020-11-24 博雅生物制药集团股份有限公司 一种人凝血因子ⅷ的制备方法
CN111065735B (zh) * 2017-08-31 2023-07-07 株式会社绿十字 用于纯化硫酸酯酶蛋白的方法
WO2019086463A1 (en) 2017-10-30 2019-05-09 Baxalta GmbH Environmentally compatible detergents for inactivation of lipid-enveloped viruses
JP7699537B2 (ja) 2018-08-31 2025-06-27 ジェンザイム・コーポレーション 無菌クロマトグラフィー樹脂および製造方法におけるその使用
WO2021147857A1 (en) * 2020-01-20 2021-07-29 Wuxi Biologics (Shanghai) Co., Ltd A novel wash buffer solution for affinity chromatography
CN118217951B (zh) * 2024-04-01 2025-05-23 山东建筑大学 一种水中的高纯度磷回收装置和方法

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1707634A1 (en) * 2005-03-29 2006-10-04 Octapharma AG Method for isolation of recombinantly produced proteins

Family Cites Families (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4540573A (en) 1983-07-14 1985-09-10 New York Blood Center, Inc. Undenatured virus-free biologically active protein derivatives
US5605884A (en) * 1987-10-29 1997-02-25 Rhone-Poulenc Rorer Pharmaceuticals Inc. Factor VIII formulations in high ionic strength media
US5316680A (en) * 1992-10-21 1994-05-31 Cornell Research Foundation, Inc. Multimodal chromatographic separation media and process for using same
WO1994029992A1 (en) 1993-06-11 1994-12-22 Northern Telecom Limited Method and apparatus for providing user controlled call management services
DE4337573C1 (de) * 1993-11-04 1995-05-18 Octapharma Ag Verfahren zur Herstellung einer virusinaktivierten Faktor VIII enthaltenden Fraktion mittels chromatographischer Methoden
SE9403915D0 (sv) 1994-11-14 1994-11-14 Annelie Almstedt Process A
AUPR638801A0 (en) * 2001-07-13 2001-08-09 Life Therapeutics Limited Factor viii separation
KR101150050B1 (ko) 2004-02-27 2012-07-05 지이 헬스케어 바이오-사이언시스 에이비 항체 정제 방법
US9624260B2 (en) * 2004-06-07 2017-04-18 Therapure Biopharma Inc. Process for isolation of plasma or serum proteins
FR2887883B1 (fr) * 2005-06-29 2007-08-31 Lab Francais Du Fractionnement Procede de separation des proteines fibrinogene, facteur xiii et colle biologique d'une fraction plasmatique solubilisee et de preparation de concentres lyophilises desdites proteines
EP1739179A1 (en) 2005-06-30 2007-01-03 Octapharma AG Serum-free stable transfection and production of recombinant human proteins in human cell lines
CN101506222B (zh) 2006-07-14 2013-10-02 健泰科生物技术公司 重组蛋白的重折叠
RU2324495C1 (ru) * 2006-08-31 2008-05-20 Федеральное государственное унитарное предприятие "Научно-производственное объединение по медицинским иммунобиологическим препаратам "Микроген" Министерства здравоохранения Российской Федерации Способ получения препарата фактора свертывания viii крови человека
US8022187B2 (en) * 2007-02-01 2011-09-20 Baxter International Inc. FVIII-independent FIX-mutant proteins for hemophilia A treatment
PL2167117T3 (pl) * 2007-06-13 2013-01-31 Csl Behring Gmbh Zastosowanie stabilizowanego VWP preparatu FVIII do podawania pozanaczyniowego w terapii i profilaktyce zaburzeń krzepliwości krwi
BRPI0814220B8 (pt) * 2007-07-11 2021-05-25 Novo Nordisk As purificação de fator viii usando uma resina multimodal ou de modo misto
GB0723712D0 (en) * 2007-12-04 2008-01-16 Apitope Technology Bristol Ltd Peptides
DE102008032361A1 (de) * 2008-07-10 2010-01-21 Csl Behring Gmbh Der Einsatz von Faktor VIII und vWF bzw. vWF-enthaltenden Konzentraten zur Therapie der durch Thrombocyten-Inhibitoren induzierte Koagulopathie

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1707634A1 (en) * 2005-03-29 2006-10-04 Octapharma AG Method for isolation of recombinantly produced proteins

Also Published As

Publication number Publication date
JP2011525523A (ja) 2011-09-22
RU2698392C2 (ru) 2019-08-26
US20110160435A1 (en) 2011-06-30
ZA201009162B (en) 2011-10-26
KR101700722B1 (ko) 2017-01-31
UA100901C2 (ru) 2013-02-11
EP2537862A1 (en) 2012-12-26
BRPI0914695B1 (pt) 2022-04-19
PT2300497E (pt) 2012-10-30
DK2300497T3 (da) 2012-10-29
US8329871B2 (en) 2012-12-11
WO2009156430A1 (en) 2009-12-30
RU2015141849A (ru) 2018-12-28
SI2300497T1 (sl) 2013-02-28
KR101804136B1 (ko) 2017-12-04
RU2567811C2 (ru) 2015-11-10
AU2009264282A1 (en) 2009-12-30
KR20170102065A (ko) 2017-09-06
EP2300497A1 (en) 2011-03-30
KR20110038634A (ko) 2011-04-14
RU2015141849A3 (enExample) 2018-12-28
IL229583A0 (en) 2014-01-30
RU2011102437A (ru) 2012-07-27
IL209758A0 (en) 2011-02-28
JP5619738B2 (ja) 2014-11-05
CA2728047C (en) 2019-07-30
CN102066417A (zh) 2011-05-18
CA2728047A1 (en) 2009-12-30
BRPI0914695A2 (pt) 2015-10-20
ES2538706T3 (es) 2015-06-23
PL2300497T3 (pl) 2013-02-28
CN102066417B (zh) 2015-11-25
IL209758A (en) 2014-02-27
KR20160104740A (ko) 2016-09-05
EP2537862B1 (en) 2015-03-18
MX2010013908A (es) 2011-01-21
EP2300497B1 (en) 2012-08-08
IL229583B (en) 2018-03-29
DK2537862T3 (en) 2015-06-15
ES2391613T3 (es) 2012-11-28

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