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

A process of purifying coagulation factor VIII Download PDF

Info

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
Authority
AU
Australia
Prior art keywords
fviii
resin
buffer
chromatography
elution
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.)
Active
Application number
AU2009264282A
Other languages
English (en)
Other versions
AU2009264282A1 (en
Inventor
Carin Borgvall
Ulrika Ericsson
Gustav Gilljam
Mats Jernberg
Stefan Winge
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.)
Octapharma AG
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=40076764&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=AU2009264282(B2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Octapharma AG filed Critical Octapharma AG
Publication of AU2009264282A1 publication Critical patent/AU2009264282A1/en
Application granted granted Critical
Publication of AU2009264282B2 publication Critical patent/AU2009264282B2/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • 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

Landscapes

  • 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)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Hematology (AREA)
  • Biophysics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Immunology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (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 2008-06-24
EP08158893.1 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) EP2537862B1 (enExample)
JP (1) JP5619738B2 (enExample)
KR (3) KR20160104740A (enExample)
CN (1) CN102066417B (enExample)
AU (1) AU2009264282B2 (enExample)
BR (1) BRPI0914695B1 (enExample)
CA (1) CA2728047C (enExample)
DK (2) DK2537862T3 (enExample)
ES (2) ES2538706T3 (enExample)
IL (3) IL209758A (enExample)
MX (1) MX2010013908A (enExample)
PL (1) PL2300497T3 (enExample)
PT (1) PT2300497E (enExample)
RU (2) RU2698392C2 (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
WO2009007451A1 (en) 2007-07-11 2009-01-15 Novo Nordisk A/S Purification of factor viii using a mixed-mode or multimodal resin
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)
MX2011001624A (es) 2008-08-21 2011-03-28 Octapharma Ag Factor viii y ix humano producido en forma recombinante.
CA2735376C (en) * 2008-09-03 2016-11-29 Octapharma Ag New protecting compositions for recombinantly produced factor viii
US20110166332A1 (en) * 2008-09-12 2011-07-07 Ge Healthcare Bio-Sciences Ab Enhanced antibody aggregate removal with capto adhere in the presence of protein-excluded zwitterions
ES2596727T3 (es) * 2010-03-30 2017-01-11 Octapharma Ag Procedimiento de purificación de un factor proteico de crecimiento G-CSF
ES2740825T3 (es) * 2010-03-30 2020-02-06 Octapharma Ag Un procedimiento de purificación de proteínas dependientes de vitamina K
DK2561070T3 (en) 2010-04-20 2015-08-17 Octapharma Ag NEW STABILIZER FOR PHARMACEUTICAL 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
EP4353743A3 (en) * 2011-05-13 2024-07-17 Octapharma AG A method of increasing the productivity of eucaryotic cells in the production of recombinant fviii
KR102001662B1 (ko) 2011-06-17 2019-10-01 학교법인 히가시-니뽄-가쿠엔 루프스 안티코아귤란트 검출용 혈액 응고시간의 측정방법
WO2013062841A1 (en) * 2011-10-26 2013-05-02 Bio-Rad Laboratories, Inc. Removal of virucidal agents in mixed mode chromatography
CA2888824C (en) * 2012-10-24 2021-02-02 Genzyme Corporation Elution of biomolecules from multi-modal resins using mes as mobile phase modifier
US20140154233A1 (en) * 2012-12-05 2014-06-05 Csl Limited Method of purifying therapeutic proteins
US10188965B2 (en) 2012-12-05 2019-01-29 Csl Behring Gmbh Hydrophobic charge induction chromatographic depletion of a protein from a solution
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
RU2768003C2 (ru) * 2013-03-08 2022-03-22 Джензим Корпорейшн Интегрированное непрерывное производство терапевтических белковых лекарственных веществ
WO2014201400A2 (en) * 2013-06-13 2014-12-18 Biogen Idec Ma Inc. Anti-factor viii antibodies or uses thereof
SG11201508835YA (en) 2013-07-12 2015-11-27 Merck Patent Gmbh Removal of fragments from a sample containing a target protein using activated carbon
US10947269B2 (en) 2013-08-08 2021-03-16 Bioverativ Therapeutics Inc. Purification of chimeric FVIII molecules
WO2015044836A1 (en) 2013-09-24 2015-04-02 Pfizer Inc. Compositions comprising heterogeneous populations of recombinant human clotting factor xa proteins
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
TWI671312B (zh) * 2014-01-17 2019-09-11 美商健臻公司 無菌層析法及製法
AU2015207472B2 (en) * 2014-01-20 2018-11-22 Octapharma Ag A process for manufacturing factor VIII having an improved ratio of FVIII:C/FVIII:Ag
ES2688066T3 (es) * 2014-01-24 2018-10-30 Am-Pharma B.V. Procesamiento para recuperación y purificación de una fosfatasa alcalina
US20160347787A1 (en) 2014-02-04 2016-12-01 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
KR20170010750A (ko) 2014-05-29 2017-02-01 에이전시 포 사이언스, 테크놀로지 앤드 리서치 단백질 추출 방법들
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
CN111183151B (zh) * 2017-06-23 2024-06-07 武田药品工业株式会社 因子viii亚种的纯化
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
US11584777B2 (en) 2017-08-31 2023-02-21 Green Cross Corporation Method for purifying a sulfatase protein
ES2991988T3 (es) 2017-10-30 2024-12-05 Takeda Pharmaceuticals Co Detergentes compatibles con el medio ambiente para la inactivación de virus con envoltura lipídica
AU2019332764B2 (en) 2018-08-31 2025-05-29 Genzyme Corporation Sterile chromatography resin and use thereof in manufacturing processes
EP4093745A4 (en) * 2020-01-20 2024-03-06 Wuxi Biologics Ireland Limited NEW 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
DE69402716T2 (de) 1993-06-11 1997-12-11 Northern Telecom Ltd., Montreal, Quebec Verfahren zur versorgung von durch den anwender gesteuerten anrufverwaltungsdiensten
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
AU2005216847B2 (en) * 2004-02-27 2010-04-01 Cytiva Bioprocess R&D Ab A process for the purification of antibodies
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
BRPI0713252C1 (pt) * 2006-07-14 2021-05-25 Genentech Inc processo para a recuperação de fator de crescimento endotelial vascular (vegf) recombinante reenovelado
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
WO2008092644A2 (en) * 2007-02-01 2008-08-07 Baxter International Inc. Fviii-independent fix-mutant proteins for hemophilia a treatment
DK2167117T3 (da) * 2007-06-13 2012-11-19 Csl Behring Gmbh Anvendelse af VWF-stabiliserede FVIII-præparater til ekstravaskulær administration til terapeutisk og profylaktisk behandling af blødningsforstyrrelser
WO2009007451A1 (en) * 2007-07-11 2009-01-15 Novo Nordisk A/S Purification of factor viii using a mixed-mode or multimodal resin
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
RU2015141849A (ru) 2018-12-28
KR20170102065A (ko) 2017-09-06
IL209758A0 (en) 2011-02-28
IL229583B (en) 2018-03-29
ES2538706T3 (es) 2015-06-23
US20110160435A1 (en) 2011-06-30
ES2391613T3 (es) 2012-11-28
CA2728047A1 (en) 2009-12-30
WO2009156430A1 (en) 2009-12-30
DK2300497T3 (da) 2012-10-29
BRPI0914695B1 (pt) 2022-04-19
CN102066417A (zh) 2011-05-18
ZA201009162B (en) 2011-10-26
PL2300497T3 (pl) 2013-02-28
RU2011102437A (ru) 2012-07-27
IL209758A (en) 2014-02-27
CN102066417B (zh) 2015-11-25
RU2567811C2 (ru) 2015-11-10
IL229583A0 (en) 2014-01-30
EP2537862B1 (en) 2015-03-18
EP2300497A1 (en) 2011-03-30
DK2537862T3 (en) 2015-06-15
RU2015141849A3 (enExample) 2018-12-28
MX2010013908A (es) 2011-01-21
AU2009264282A1 (en) 2009-12-30
BRPI0914695A2 (pt) 2015-10-20
JP5619738B2 (ja) 2014-11-05
CA2728047C (en) 2019-07-30
KR20110038634A (ko) 2011-04-14
SI2300497T1 (sl) 2013-02-28
EP2300497B1 (en) 2012-08-08
PT2300497E (pt) 2012-10-30
RU2698392C2 (ru) 2019-08-26
EP2537862A1 (en) 2012-12-26
KR20160104740A (ko) 2016-09-05
KR101804136B1 (ko) 2017-12-04
US8329871B2 (en) 2012-12-11
JP2011525523A (ja) 2011-09-22
UA100901C2 (ru) 2013-02-11
KR101700722B1 (ko) 2017-01-31

Similar Documents

Publication Publication Date Title
AU2009264282B2 (en) A process of purifying coagulation factor VIII
JP6216930B2 (ja) 組換えａｄａｍｔｓ１３および他のタンパク質を精製する方法ならびにそれらの組成物
AU2011234521B2 (en) A process for purifying Vitamin K dependent proteins such as coagulation factor IX
CA2934705C (en) A process for manufacturing factor viii having an improved ratio of fviii:c/fviii:ag
EP0573605B1 (en) Preparation of factor ix
CN103814137A (zh) 处理凝血因子的方法

Legal Events

Date Code Title Description
FGA Letters patent sealed or granted (standard patent)