EP2438165A1 - Composition de complexe prothrombique - Google Patents

Composition de complexe prothrombique

Info

Publication number
EP2438165A1
EP2438165A1 EP10728330A EP10728330A EP2438165A1 EP 2438165 A1 EP2438165 A1 EP 2438165A1 EP 10728330 A EP10728330 A EP 10728330A EP 10728330 A EP10728330 A EP 10728330A EP 2438165 A1 EP2438165 A1 EP 2438165A1
Authority
EP
European Patent Office
Prior art keywords
protein
factor
proteins
eluate
hydroxyapatite
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.)
Withdrawn
Application number
EP10728330A
Other languages
German (de)
English (en)
French (fr)
Inventor
Jacques Chabbat
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.)
LFB SA
Original Assignee
LFB 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 LFB SA filed Critical LFB SA
Publication of EP2438165A1 publication Critical patent/EP2438165A1/fr
Withdrawn legal-status Critical Current

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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
    • 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)
    • C12N9/644—Coagulation factor IXa (3.4.21.22)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • 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
    • 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
    • C12N7/00—Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof
    • C12N7/04—Inactivation or attenuation; Producing viral sub-units
    • 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)
    • C12N9/6429—Thrombin (3.4.21.5)
    • 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)
    • C12N9/6432—Coagulation factor Xa (3.4.21.6)
    • 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)
    • C12N9/6437—Coagulation factor VIIa (3.4.21.21)
    • 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)
    • C12N9/6464—Protein C (3.4.21.69)
    • 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
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/56—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving blood clotting factors, e.g. involving thrombin, thromboplastin, fibrinogen
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y304/00—Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
    • C12Y304/21—Serine endopeptidases (3.4.21)
    • C12Y304/21005—Thrombin (3.4.21.5)
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y304/00—Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
    • C12Y304/21—Serine endopeptidases (3.4.21)
    • C12Y304/21006—Coagulation factor Xa (3.4.21.6)
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y304/00—Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
    • C12Y304/21—Serine endopeptidases (3.4.21)
    • C12Y304/21021—Coagulation factor VIIa (3.4.21.21)
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y304/00—Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
    • C12Y304/21—Serine endopeptidases (3.4.21)
    • C12Y304/21022—Coagulation factor IXa (3.4.21.22)
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y304/00—Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
    • C12Y304/21—Serine endopeptidases (3.4.21)
    • C12Y304/21069—Protein C activated (3.4.21.69)

Definitions

  • vitamin K-dependent protein concentrates and, more particularly, prothrombin complex concentrates comprising the
  • the method of the invention comprises the addition of a thrombin inhibitor, preferably antithrombin III or a mixture of antithrombin III and heparin after step b) or after step d).
  • a thrombin inhibitor preferably antithrombin III or a mixture of antithrombin III and heparin after step b) or after step d).
  • cryosurnagen The centrifugation supernatant is called cryosurnagen.

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Genetics & Genomics (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Health & Medical Sciences (AREA)
  • Biochemistry (AREA)
  • Biomedical Technology (AREA)
  • General Engineering & Computer Science (AREA)
  • Medicinal Chemistry (AREA)
  • Molecular Biology (AREA)
  • Microbiology (AREA)
  • Biotechnology (AREA)
  • Hematology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biophysics (AREA)
  • Immunology (AREA)
  • Analytical Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Toxicology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Veterinary Medicine (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Virology (AREA)
  • Neurosurgery (AREA)
  • Physics & Mathematics (AREA)
  • Diabetes (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
EP10728330A 2009-06-05 2010-06-04 Composition de complexe prothrombique Withdrawn EP2438165A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR0902723A FR2946348B1 (fr) 2009-06-05 2009-06-05 Procede de preparation d'une composition de complexe prothrombique a haut degre de purete
PCT/IB2010/052497 WO2010140140A1 (fr) 2009-06-05 2010-06-04 Composition de complexe prothrombique

Publications (1)

Publication Number Publication Date
EP2438165A1 true EP2438165A1 (fr) 2012-04-11

Family

ID=41531870

Family Applications (1)

Application Number Title Priority Date Filing Date
EP10728330A Withdrawn EP2438165A1 (fr) 2009-06-05 2010-06-04 Composition de complexe prothrombique

Country Status (11)

Country Link
US (1) US20120087907A1 (zh)
EP (1) EP2438165A1 (zh)
JP (1) JP2012528850A (zh)
KR (1) KR20120047216A (zh)
CN (1) CN102459583A (zh)
AU (1) AU2010255377A1 (zh)
BR (1) BRPI1009641A2 (zh)
CA (1) CA2764584A1 (zh)
FR (1) FR2946348B1 (zh)
IL (1) IL216395A0 (zh)
WO (1) WO2010140140A1 (zh)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TWI641382B (zh) * 2013-01-31 2018-11-21 韓美藥品股份有限公司 於包含因子ｖｉｉ之組成物中使病毒失活之方法
CN103351432A (zh) * 2013-07-09 2013-10-16 武汉中原瑞德生物制品有限责任公司 从血浆组分沉淀中提取人凝血因子ⅷ和人纤维蛋白原的工艺
CN105440127B (zh) * 2015-12-30 2018-10-16 上海莱士血液制品股份有限公司 一种以人血浆Cohn组分III为原料的FEIBA的制备方法
EP3400029B1 (en) * 2016-01-07 2022-03-02 Eio Biomedical Ltd Compositions for reducing tissue adhesions
CN106139935A (zh) * 2016-06-23 2016-11-23 广州新克力生物科技有限公司 一种白细胞和血小板的过滤膜及其制备方法
SG10201912497WA (en) 2017-02-09 2020-02-27 Csl Behring Gmbh A blood coagulation factor replacement product for use in the treatment or prophylaxis of bleedings
CN109943554B (zh) * 2017-12-21 2021-04-16 舒泰神（北京）生物制药股份有限公司 一种从蛇毒中提取凝血因子x激活剂的方法
CN109593747B (zh) * 2018-12-25 2021-08-10 山东泰邦生物制品有限公司 一种人凝血酶原复合物中间产品液态保存的方法
CN110835626B (zh) * 2019-12-04 2021-12-21 长春雷允上药业有限公司 一种凝血酶的制备方法

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0346241A1 (fr) * 1988-06-09 1989-12-13 Fondation Nationale De Transfusion Sanguine Procédé de préparation d'une fraction concentrée en facteur Vlla et son application à titre de médicament

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DE2902158A1 (de) 1979-01-20 1980-07-31 Biotest Serum Institut Gmbh Verfahren zur herstellung von fibrinogen, einem die gerinnungsfaktoren ii, vii, ix und x enthaltenden prothrombinkomplex, antithrombin iii und einer loesung von lagerstabilen serumproteinen
DE3101752A1 (de) 1981-01-21 1982-08-26 Behringwerke Ag, 3550 Marburg "verfahren zur reinigung der blutgerinnungsfaktoren ii, vii, ix und/oder x und danach hergestellte praeparationen"
FR2679251B1 (fr) 1991-07-18 1993-11-12 Nord Assoc Essor Transfusion San Procede de preparation d'un concentre de thrombine humaine destine a un usage therapeutique.
US5714583A (en) 1995-06-07 1998-02-03 Genetics Institute, Inc. Factor IX purification methods
HUP9700603A3 (en) * 1996-03-20 2001-08-28 Baxter Ag Pharmaceutical preparation for the treatment of blood coagulation disorders
CN101160133B (zh) * 2004-11-05 2013-01-09 普罗瑟拉生物公司 治疗用途的来自人血浆的内-α抑制剂蛋白质的制备和组合物
EP1831242B1 (en) * 2004-12-23 2012-09-26 Novo Nordisk Health Care AG Reduction of the content of protein contaminants in compositions comprising a vitamin k-dependent protein of interest
JP2006197464A (ja) 2005-01-17 2006-07-27 Sharp Corp 電話システム

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0346241A1 (fr) * 1988-06-09 1989-12-13 Fondation Nationale De Transfusion Sanguine Procédé de préparation d'une fraction concentrée en facteur Vlla et son application à titre de médicament

Non-Patent Citations (5)

* Cited by examiner, † Cited by third party
Title
CSL BEHRING GMBH: "PUBLIC ASSESSMENT REPORT BERIPLEX P/N 250 BERIPLEX P/N 500 HUMAN PROTHROMBIN COMPLEX DE/H/0477/001-002/MR APPLICANT: CSL BEHRING GMBH", 11 January 2008 (2008-01-11), pages 1 - 34, XP055285221, Retrieved from the Internet <URL:http://portal.dimdi.de/amispb/doc/pei/Web/2600004-paren-20080111.pdf> [retrieved on 20160701] *
JOSIC D ET AL: "Manufcturing of a Prothrombin Complex Concentrate Aiming at Low Thrombogenicity", THROMBOSIS RESEARCH, TARRYTOWN, NY, US, vol. 100, 1 January 2000 (2000-01-01), pages 433 - 441, XP003028450, ISSN: 0049-3848 *
JOSIC D ET AL: "Preparation of vitamin K-dependent proteins, such as clotting factors II, VII, IX and X and clotting inhibitor Protein C", JOURNAL OF CHROMATOGRAPHY B: BIOMEDICAL SCIENCES & APPLICATI, ELSEVIER, AMSTERDAM, NL, vol. 790, no. 1-2, 25 June 2003 (2003-06-25), pages 183 - 197, XP004426799, ISSN: 1570-0232, DOI: 10.1016/S1570-0232(03)00082-5 *
S CHANDRA ET AL: "Prothrombin Complex Concentrates for Clinical Use", VOX SANG., vol. 41, 1 January 1981 (1981-01-01), pages 257 - 273, XP055572119 *
See also references of WO2010140140A1 *

Also Published As

Publication number Publication date
BRPI1009641A2 (pt) 2015-08-18
CA2764584A1 (fr) 2010-12-09
FR2946348A1 (fr) 2010-12-10
KR20120047216A (ko) 2012-05-11
US20120087907A1 (en) 2012-04-12
AU2010255377A1 (en) 2011-12-15
CN102459583A (zh) 2012-05-16
WO2010140140A1 (fr) 2010-12-09
JP2012528850A (ja) 2012-11-15
IL216395A0 (en) 2012-01-31
FR2946348B1 (fr) 2011-08-05

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