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
Links
- 108010054265 Factor VIIa Proteins 0.000 title abstract 2
- 239000012141 concentrate Substances 0.000 title abstract 2
- 238000004519 manufacturing process Methods 0.000 title abstract 2
- 229940012413 factor vii Drugs 0.000 abstract 4
- 230000004913 activation Effects 0.000 abstract 2
- 108090000623 proteins and genes Proteins 0.000 abstract 2
- 102000004169 proteins and genes Human genes 0.000 abstract 2
- NWUYHJFMYQTDRP-UHFFFAOYSA-N 1,2-bis(ethenyl)benzene;1-ethenyl-2-ethylbenzene;styrene Chemical compound C=CC1=CC=CC=C1.CCC1=CC=CC=C1C=C.C=CC1=CC=CC=C1C=C NWUYHJFMYQTDRP-UHFFFAOYSA-N 0.000 abstract 1
- 101000856746 Bos taurus Cytochrome c oxidase subunit 7A1, mitochondrial Proteins 0.000 abstract 1
- 230000001419 dependent effect Effects 0.000 abstract 1
- 230000000694 effects Effects 0.000 abstract 1
- 229940012414 factor viia Drugs 0.000 abstract 1
- 239000003456 ion exchange resin Substances 0.000 abstract 1
- 229920003303 ion-exchange polymer Polymers 0.000 abstract 1
- 238000000034 method Methods 0.000 abstract 1
- MBWXNTAXLNYFJB-NKFFZRIASA-N phylloquinone Chemical compound C1=CC=C2C(=O)C(C/C=C(C)/CCC[C@H](C)CCC[C@H](C)CCCC(C)C)=C(C)C(=O)C2=C1 MBWXNTAXLNYFJB-NKFFZRIASA-N 0.000 abstract 1
- 238000000746 purification Methods 0.000 abstract 1
- 239000006228 supernatant Substances 0.000 abstract 1
Classifications
-
- 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)
-
- 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
- A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
-
- 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)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal 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.
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)
| 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)
| 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 |
-
1991
- 1991-12-16 FR FR9115601A patent/FR2684999A1/fr active Granted
-
1992
- 1992-12-01 ES ES92403234T patent/ES2056782T3/es not_active Expired - Lifetime
- 1992-12-01 DE DE92403234T patent/DE547932T1/de active Pending
- 1992-12-01 EP EP92403234A patent/EP0547932B1/fr not_active Expired - Lifetime
- 1992-12-01 DE DE69213421T patent/DE69213421T2/de not_active Expired - Lifetime
- 1992-12-01 AT AT92403234T patent/ATE142255T1/de active
- 1992-12-01 DK DK92403234.5T patent/DK0547932T3/da active
- 1992-12-10 US US07/988,776 patent/US5344918A/en not_active Expired - Lifetime
- 1992-12-16 JP JP4354440A patent/JP2533050B2/ja not_active Expired - Fee Related
-
1993
- 1993-09-30 GR GR930300094T patent/GR930300094T1/el unknown
-
1996
- 1996-12-04 GR GR960403286T patent/GR3021875T3/el unknown
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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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FG2A | Definitive protection |
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