ES2056782T1 - Procedimiento de fabricacion de un concentrado de factor vii activado de elevada pureza. - Google Patents

Procedimiento de fabricacion de un concentrado de factor vii activado de elevada pureza.

Info

Publication number
ES2056782T1
ES2056782T1 ES92403234T ES92403234T ES2056782T1 ES 2056782 T1 ES2056782 T1 ES 2056782T1 ES 92403234 T ES92403234 T ES 92403234T ES 92403234 T ES92403234 T ES 92403234T ES 2056782 T1 ES2056782 T1 ES 2056782T1
Authority
ES
Spain
Prior art keywords
factor vii
activated
factor
high purity
manufacturing procedure
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.)
Granted
Application number
ES92403234T
Other languages
English (en)
Other versions
ES2056782T3 (es
Inventor
Bernard Dazey
Mohamed Hamsany
Sylvia Enfedaque-Morer
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.)
AQUITAINE DEV TRANSF SANGUINE
Original Assignee
AQUITAINE DEV TRANSF SANGUINE
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 AQUITAINE DEV TRANSF SANGUINE filed Critical AQUITAINE DEV TRANSF SANGUINE
Publication of ES2056782T1 publication Critical patent/ES2056782T1/es
Application granted granted Critical
Publication of ES2056782T3 publication Critical patent/ES2056782T3/es
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • 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)
    • C12N9/6437Coagulation factor VIIa (3.4.21.21)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/02Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12YENZYMES
    • C12Y304/00Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
    • C12Y304/21Serine endopeptidases (3.4.21)
    • C12Y304/21021Coagulation factor VIIa (3.4.21.21)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Genetics & Genomics (AREA)
  • General Health & Medical Sciences (AREA)
  • Biochemistry (AREA)
  • Biomedical Technology (AREA)
  • General Engineering & Computer Science (AREA)
  • Medicinal Chemistry (AREA)
  • Microbiology (AREA)
  • Biotechnology (AREA)
  • Molecular Biology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Polysaccharides And Polysaccharide Derivatives (AREA)

Abstract

LA INVENCION SE REFIERE A UN PROCESO DE FABRICACION DE UN CONCENTRADO DE FACTOR VII ACTIVADO DE GRAN PUREZA. ESTE PROCESO COMPRENDE EL EMPLEO DE UN PLASMA DESPROVISTO DE CRIOPRECIPITADO, PREFERENTEMENTE DE ORIGEN HUMANO, ASI COMO AL MENOS UNA ETAPA DE PURIFICACION POR AL MENOS UNA CROMATOGRAFIA SOBRE RESINA DE INTERCAMBIO DE IONES ASI COMO UNA ETAPA DE ACTIVACION DEL FACTOR VII, CARACTERIZADO EN QUE SE REALIZA EN PRIMER LUGAR LA ACTIVACION DIRECTA DEL FACTOR VII EN EL SUPERNATANTE BRUTO DE PLASMA DESPROVISTO DE CRIOPRECIPITADO, SIN APORTE DE PROTEINAS EXOGENAS. GRACIAS A LA INVENCION, EL FACTOR VII ACTIVADO DE GRAN PUREZA, ESTA ESENCIALMENTE DESPROVISTO DE LOS FACTORES VITAMINA K DEPENDIENTES Y DE LOS FACTORES VIIIC Y VIIICAG Y PRESENTA UNA RELACION FACTOR VIIA/FACTOR VII SUPERIOR A 5 CON UNA ACTIVIDAD ESPECIFICA DEL FACTOR VII ACTIVADO SUPERIOR A 200 UL/MG DE PROTEINAS.
ES92403234T 1991-12-16 1992-12-01 Procedimiento de fabricacion de un concentrado de factor vii activado de alta pureza. Expired - Lifetime ES2056782T3 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
FR9115601A FR2684999A1 (fr) 1991-12-16 1991-12-16 Procede de fabrication d'un concentre de facteur vii active de haute purete essentiellement depourvu des facteurs vitamine k dependants et des facteurs viiic et viiicag.

Publications (2)

Publication Number Publication Date
ES2056782T1 true ES2056782T1 (es) 1994-10-16
ES2056782T3 ES2056782T3 (es) 1997-02-16

Family

ID=9420096

Family Applications (1)

Application Number Title Priority Date Filing Date
ES92403234T Expired - Lifetime ES2056782T3 (es) 1991-12-16 1992-12-01 Procedimiento de fabricacion de un concentrado de factor vii activado de alta pureza.

Country Status (9)

Country Link
US (1) US5344918A (es)
EP (1) EP0547932B1 (es)
JP (1) JP2533050B2 (es)
AT (1) ATE142255T1 (es)
DE (2) DE547932T1 (es)
DK (1) DK0547932T3 (es)
ES (1) ES2056782T3 (es)
FR (1) FR2684999A1 (es)
GR (2) GR930300094T1 (es)

Families Citing this family (37)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5664362A (en) * 1993-09-03 1997-09-09 The Board Of Supervisors Of Louisiana State University And Agricultural And Mechanical College Fishing lure which releases the involuntary biting reflex of largemouth bass and other fishes within the family centrachidae
DE19538716A1 (de) * 1995-10-18 1997-04-24 Behringwerke Ag Verfahren zur Quantifizierung von aktiviertem Gerinnungsfaktor VII (FVIIa)
DE19531637A1 (de) * 1995-08-28 1997-03-06 Immuno Ag Pharmazeutische Zusammensetzung zur Behandlung von Blutgerinnungsstörugnen, Verfahren zur Herstellung derselben und deren Verwendung
DE19538715A1 (de) 1995-10-18 1997-04-30 Behringwerke Ag Verfahren zur Reinigung von Faktor VII und aktiviertem Faktor VII
AU781717B2 (en) * 1998-04-24 2005-06-09 Csl Behring Gmbh Process for the preparation in pure form of the protease activating blood clotting factor VII, its proenzyme or mixture of both proteins by means of ion-exchange chromatography
AT408613B (de) 1998-06-17 2002-01-25 Immuno Ag Pharmazeutisches faktor vii-präparat
US7049110B2 (en) 1998-07-21 2006-05-23 Gambro, Inc. Inactivation of West Nile virus and malaria using photosensitizers
US6258577B1 (en) 1998-07-21 2001-07-10 Gambro, Inc. Method and apparatus for inactivation of biological contaminants using endogenous alloxazine or isoalloxazine photosensitizers
US6277337B1 (en) 1998-07-21 2001-08-21 Gambro, Inc. Method and apparatus for inactivation of biological contaminants using photosensitizers
US7498156B2 (en) 1998-07-21 2009-03-03 Caridianbct Biotechnologies, Llc Use of visible light at wavelengths of 500 to 550 nm to reduce the number of pathogens in blood and blood components
US6444788B1 (en) * 1999-03-15 2002-09-03 Novo Nordisk A/S Ion exchange chromatography of GLP-1, analogs and derivatives thereof
US6451987B1 (en) 1999-03-15 2002-09-17 Novo Nordisk A/S Ion exchange chromatography of proteins and peptides
US7220747B2 (en) 1999-07-20 2007-05-22 Gambro, Inc. Method for preventing damage to or rejuvenating a cellular blood component using mitochondrial enhancer
US7094378B1 (en) 2000-06-15 2006-08-22 Gambro, Inc. Method and apparatus for inactivation of biological contaminants using photosensitizers
DE19937218A1 (de) * 1999-08-06 2001-02-08 Aventis Behring Gmbh Verfahren zur Reindarstellung der den Blutgerinnungsfaktor VII aktivierenden Protease, ihres Proenzyms oder eines Gemisches beider Proteine mittels Affinitätschromatographie
US6268120B1 (en) 1999-10-19 2001-07-31 Gambro, Inc. Isoalloxazine derivatives to neutralize biological contaminants
US7648699B2 (en) 2000-06-02 2010-01-19 Caridianbct Biotechnologies, Llc Preventing transfusion related complications in a recipient of a blood transfusion
TW590780B (en) 2000-06-02 2004-06-11 Gambro Inc Additive solutions containing riboflavin
US7985588B2 (en) 2000-06-02 2011-07-26 Caridianbct Biotechnologies, Llc Induction of and maintenance of nucleic acid damage in pathogens using riboflavin and light
US9044523B2 (en) 2000-06-15 2015-06-02 Terumo Bct, Inc. Reduction of contaminants in blood and blood products using photosensitizers and peak wavelengths of light
AU2002351756A1 (en) 2001-12-21 2003-07-15 Novo Nordisk Health Care Ag Liquid composition of factor vii polypeptides
PT1517698E (pt) 2002-06-21 2014-11-19 Novo Nordisk Healthcare Ag Composições sólidas estabilizadas de polipéptidos do fator viia
RU2364626C2 (ru) 2003-03-18 2009-08-20 Ново Нордиск Хелт Кэр Аг Способ получения, способ очистки и способ стабилизации полипептидов фактора vii, ix и x
US7897734B2 (en) 2003-03-26 2011-03-01 Novo Nordisk Healthcare Ag Method for the production of proteins
KR20060015574A (ko) 2003-05-23 2006-02-17 노보 노르디스크 헬스 케어 악티엔게젤샤프트 용액 중 단백질 안정화
WO2004112828A1 (en) 2003-06-25 2004-12-29 Novo Nordisk Health Care Ag Liquid composition of factor vii polypeptides
ES2574581T3 (es) 2003-08-14 2016-06-20 Novo Nordisk Health Care Ag Composición farmacéutica líquida acuosa de polipéptidos de tipo Factor VII
EP1664108B1 (en) * 2003-08-21 2009-10-14 Novo Nordisk A/S Separation of polypeptides comprising a racemized amino acid
RU2373953C2 (ru) 2003-12-19 2009-11-27 Ново Нордиск Хелс Кеа Аг Стабилизированная композиция, содержащая полипептид фактора vii
EP1797180A2 (en) * 2004-09-29 2007-06-20 Novo Nordisk Health Care AG Purification of a bulk of a factor vii polypeptide by fractionated elution from an anion-exchange material
ES2257225B1 (es) * 2006-02-17 2007-03-16 Grifols, S.A Preparacion terapeutica de fviia de muy alta pureza y metodo para su obtencion.
FR2901707B1 (fr) * 2006-05-31 2017-09-29 Lab Francais Du Fractionnement Composition de facteur vii recombinant ou transgenique, chaque molecule de facteur vii possedant deux sites de n-glycosylation a motifs glycanniques definis
FR2904558B1 (fr) * 2006-08-01 2008-10-17 Lab Francais Du Fractionnement "composition de facteur vii recombinant ou transgenique, presentant majoritairement des formes glycanniques biantennees, bisialylees et non fucosylees"
FR2917414B1 (fr) * 2007-06-15 2012-07-13 Lab Francais Du Fractionnement Facteur vii/viia humain modifie et composition pharmaceutique contenant celui-ci
FR2942231B1 (fr) 2009-02-19 2015-03-20 Lfb Biotechnologies Acides nucleiques se liant specifiquement au facteur vii/viia humain, et utilisations
CA2821711C (en) 2010-12-15 2017-10-10 Baxter International Inc. Eluate collection using conductivity gradient
EP2687595B1 (en) 2012-07-19 2018-05-30 Laboratoire Français du Fractionnement et des Biotechnologies Method for purifying transgenic factor VII

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS5314604B2 (es) * 1972-12-20 1978-05-18
JPS57206620A (en) * 1981-06-12 1982-12-18 Cutter Lab Blood coagulation promoter and manufacture
US4540473A (en) * 1983-11-22 1985-09-10 International Business Machines Corporation Copper plating bath having increased plating rate, and method
US4473553A (en) * 1983-12-02 1984-09-25 Miles Laboratories, Inc. Process for producing a lipoprotein-poor concentrate of coagulation factors VII and VIIa
US4470969A (en) * 1983-12-02 1984-09-11 Miles Laboratories, Inc. Process for producing a concentrate of coagulation factors VII and VIIa
FR2632524B1 (fr) * 1988-06-09 1992-03-13 Fondation Nale Transfusion San Procede de preparation d'une fraction concentree en facteur viia et son application a titre de medicament

Also Published As

Publication number Publication date
DK0547932T3 (da) 1997-02-10
ATE142255T1 (de) 1996-09-15
DE69213421T2 (de) 1997-04-03
FR2684999A1 (fr) 1993-06-18
GR3021875T3 (en) 1997-03-31
JPH05345799A (ja) 1993-12-27
EP0547932A1 (fr) 1993-06-23
JP2533050B2 (ja) 1996-09-11
ES2056782T3 (es) 1997-02-16
GR930300094T1 (en) 1993-09-30
DE69213421D1 (de) 1996-10-10
FR2684999B1 (es) 1995-05-05
US5344918A (en) 1994-09-06
EP0547932B1 (fr) 1996-09-04
DE547932T1 (de) 1994-02-03

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