ES2182915T3 - Procedimiento de purificacion del factor viii - Google Patents
Procedimiento de purificacion del factor viiiInfo
- Publication number
- ES2182915T3 ES2182915T3 ES95937285T ES95937285T ES2182915T3 ES 2182915 T3 ES2182915 T3 ES 2182915T3 ES 95937285 T ES95937285 T ES 95937285T ES 95937285 T ES95937285 T ES 95937285T ES 2182915 T3 ES2182915 T3 ES 2182915T3
- Authority
- ES
- Spain
- Prior art keywords
- viii
- factor viii
- gel
- procedure
- invention refers
- 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.)
- Expired - Lifetime
Links
- 238000000746 purification Methods 0.000 title 1
- 229960000301 factor viii Drugs 0.000 abstract 5
- 238000000034 method Methods 0.000 abstract 4
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 abstract 3
- 208000031220 Hemophilia Diseases 0.000 abstract 1
- 208000009292 Hemophilia A Diseases 0.000 abstract 1
- 230000015271 coagulation Effects 0.000 abstract 1
- 238000005345 coagulation Methods 0.000 abstract 1
- 230000003993 interaction Effects 0.000 abstract 1
- 238000004519 manufacturing process Methods 0.000 abstract 1
- 229940126601 medicinal product Drugs 0.000 abstract 1
- 239000004094 surface-active agent Substances 0.000 abstract 1
Classifications
-
- 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)
-
- 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
-
- 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)
- Life Sciences & Earth Sciences (AREA)
- Organic Chemistry (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Hematology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Toxicology (AREA)
- Molecular Biology (AREA)
- Genetics & Genomics (AREA)
- Biophysics (AREA)
- Biochemistry (AREA)
- Gastroenterology & Hepatology (AREA)
- Zoology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Public Health (AREA)
- General Chemical & Material Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Diabetes (AREA)
- Pharmacology & Pharmacy (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Veterinary Medicine (AREA)
- Peptides Or Proteins (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
- Liquid Crystal Substances (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Steroid Compounds (AREA)
Abstract
LA PRESENTE INVENCION SE REFIERE A UN PROCEDIMIENTO PARA PURIFICAR EL FACTOR VIII RECOMBINANTE DE COAGULACION MEDIANTE LA CARGA DE UNA SOLUCION ACUOSA QUE CONTIENE FACTOR VIII EN UN GEL DE CROMATOGRAFIA DE INTERACCION HIDROFOBA (HIC), EN DONDE AL MENOS HAY PRESENTE UN SURFACTANTE EN LA SOLUCION ACUOSA Y/O UNA SOLUCION DE TAMPON ES UTILIZADA PARA EQUILIBRAR EL GEL ANTES DE CARGAR LA SOLUCION ACUOSA EN EL GEL. LA PRESENCIA DE UN SURFACTANTE AL CARGAR LA SOLUCION QUE CONTIENE FACTOR VIII EN EL GEL HIC, HACE POSIBLE SEPARAR EFICAZMENTE LAS MOLECULAS DE FACTOR VIII INTACTAS Y ACTIVAS DE MOLECULAS CON DESVIOS ESTRUCTURALES. CON LA PRESENTE INVENCION ES ADEMAS POSIBLE REDUCIR EL CONTENIDO DE ADN Y/O CONTAMINANTES DE CELULA CHO DE FORMA CONSIDERABLE Y AUMENTAR LA ACTIVIDAD DEL PRODUCTO DE FACTOR VIII A UNA EXTENSION HASTA AHORA DESCONOCIDA. LA INVENCION SE REFIERE ADEMAS A UNA SOLUCION ACUOSA QUE CONTIENE FACTOR VIII RECOMBINANTE QUE HA SIDO PURIFICADO DE ACUERDO CON EL PRESENTE PROCEDIMIENTO Y ALUSO DE DICHA SOLUCION ACUOSA, PARA LA FABRICACION DE UN MEDICAMENTO PARA ADMINISTRACION A UN PACIENTE QUE TENGA LOS SINTOMAS DE HEMOFILIA. ADEMAS, LA INVENCION SE REFIERE A UN METODO DE TRATAMIENTO DE HEMOFILIA MEDIANTE LA ADMINISTRACION DE UNA CANTIDAD TERAPEUTICAMENTE EFICAZ DE FACTOR VIII RECOMBINANTE QUE HA SIDO PURIFICADO DE ACUERDO CON EL PRESENTE PROCEDIMIENTO.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| SE9403914A SE503424C2 (sv) | 1994-11-14 | 1994-11-14 | Process för rening av rekombinant koagulationsfaktor VIII |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| ES2182915T3 true ES2182915T3 (es) | 2003-03-16 |
Family
ID=20395963
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ES95937285T Expired - Lifetime ES2182915T3 (es) | 1994-11-14 | 1995-11-14 | Procedimiento de purificacion del factor viii |
Country Status (12)
| Country | Link |
|---|---|
| US (1) | US6005082A (es) |
| EP (1) | EP0792281B1 (es) |
| JP (1) | JP3871710B2 (es) |
| AT (1) | ATE225368T1 (es) |
| AU (1) | AU691993B2 (es) |
| DE (1) | DE69528471T2 (es) |
| DK (1) | DK0792281T3 (es) |
| ES (1) | ES2182915T3 (es) |
| NZ (1) | NZ295810A (es) |
| PT (1) | PT792281E (es) |
| SE (1) | SE503424C2 (es) |
| WO (1) | WO1996015140A1 (es) |
Families Citing this family (31)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6586573B1 (en) | 1999-02-22 | 2003-07-01 | Baxter International Inc. | Albumin-free Factor VIII formulations |
| US6822081B2 (en) * | 2000-01-13 | 2004-11-23 | Max-Planck Gesellschaft zur Förderung der Wissenschaften e.V. | Process for the isolation and/or purification of a proteinaceous material |
| ES2338687T3 (es) | 2000-03-27 | 2010-05-11 | Genetics Institute, Llc | Procedimientos para purificar proteinas altamente anionicas. |
| ES2321539T3 (es) * | 2001-06-05 | 2009-06-08 | Genetics Institute, Llc | Procedimientos relativos a la purificacion de proteinas altamente anionicas. |
| ES2342539T3 (es) * | 2003-10-24 | 2010-07-08 | Amgen, Inc. | Proceso para la purificacion de proteinas en una fraccion de flujo-directo de cromatografia de interaccion hidrofobica. |
| PL2167526T3 (pl) | 2007-07-11 | 2011-09-30 | Novo Nordisk As | Oczyszczanie czynnika VIII za pomocą żywicy o mieszanej funkcji lub wielofunkcyjnej |
| BRPI0921429B1 (pt) | 2008-11-07 | 2022-07-12 | Takeda Pharmaceutical Company Limited | Formulação farmacêutica liofilizada estável, e, método para preparar um fator liofilizado estável |
| US20120263701A1 (en) | 2009-08-24 | 2012-10-18 | Volker Schellenberger | Coagulation factor vii compositions and methods of making and using same |
| ES2534562T3 (es) | 2010-05-19 | 2015-04-24 | F. Hoffmann-La Roche Ag | Procedimiento de cromatografía de interacción hidrófoba |
| AU2011343813B2 (en) | 2010-12-15 | 2015-05-21 | Takeda Pharmaceutical Company Limited | Eluate collection using conductivity gradient |
| BRPI1105317A2 (pt) | 2011-01-24 | 2013-04-30 | Fundacco Hemoct De Ribeirco Preto | produÇço estÁvel e em larga escala de fviii humano em linhagem celular humana sk-hep-1 |
| EP2702077A2 (en) | 2011-04-27 | 2014-03-05 | AbbVie Inc. | Methods for controlling the galactosylation profile of recombinantly-expressed proteins |
| EP2822577B1 (en) | 2012-02-15 | 2019-02-06 | Bioverativ Therapeutics Inc. | Recombinant factor viii proteins |
| CN104487452A (zh) | 2012-02-15 | 2015-04-01 | 阿穆尼克斯运营公司 | 因子viii组合物及其制备和使用方法 |
| WO2013158279A1 (en) | 2012-04-20 | 2013-10-24 | Abbvie Inc. | Protein purification methods to reduce acidic species |
| US9181572B2 (en) | 2012-04-20 | 2015-11-10 | Abbvie, Inc. | Methods to modulate lysine variant distribution |
| US9067990B2 (en) | 2013-03-14 | 2015-06-30 | Abbvie, Inc. | Protein purification using displacement chromatography |
| US9512214B2 (en) | 2012-09-02 | 2016-12-06 | Abbvie, Inc. | Methods to control protein heterogeneity |
| WO2014143205A1 (en) | 2013-03-12 | 2014-09-18 | Abbvie Inc. | Human antibodies that bind human tnf-alpha and methods of preparing the same |
| US10023608B1 (en) | 2013-03-13 | 2018-07-17 | Amgen Inc. | Protein purification methods to remove impurities |
| US9499614B2 (en) | 2013-03-14 | 2016-11-22 | Abbvie Inc. | Methods for modulating protein glycosylation profiles of recombinant protein therapeutics using monosaccharides and oligosaccharides |
| US9017687B1 (en) | 2013-10-18 | 2015-04-28 | Abbvie, Inc. | Low acidic species compositions and methods for producing and using the same using displacement chromatography |
| TW202003554A (zh) | 2013-08-14 | 2020-01-16 | 美商百歐維拉提夫治療公司 | 因子ｖｉｉｉ－ｘｔｅｎ融合物及其用途 |
| EP3052640A2 (en) | 2013-10-04 | 2016-08-10 | AbbVie Inc. | Use of metal ions for modulation of protein glycosylation profiles of recombinant proteins |
| US9181337B2 (en) | 2013-10-18 | 2015-11-10 | Abbvie, Inc. | Modulated lysine variant species compositions and methods for producing and using the same |
| US9085618B2 (en) | 2013-10-18 | 2015-07-21 | Abbvie, Inc. | Low acidic species compositions and methods for producing and using the same |
| US20150139988A1 (en) | 2013-11-15 | 2015-05-21 | Abbvie, Inc. | Glycoengineered binding protein compositions |
| JP6909203B2 (ja) | 2015-08-03 | 2021-07-28 | バイオベラティブ セラピューティクス インコーポレイテッド | 第ｉｘ因子融合タンパク質及びそれらの製造方法及び使用方法 |
| MA46967A (fr) | 2016-12-02 | 2019-10-09 | Bioverativ Therapeutics Inc | Méthodes de traitement de l'arthropathie hémophilique à l'aide de facteurs de coagulation chimériques |
| BR112019027377A2 (pt) | 2017-06-23 | 2020-07-14 | Baxalta Incorporated | purificação de subespécies do fator viii |
| TW202015723A (zh) | 2018-05-18 | 2020-05-01 | 美商百歐維拉提夫治療公司 | 治療ａ型血友病的方法 |
Family Cites Families (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| IL74909A (en) * | 1984-04-20 | 1992-01-15 | Genentech Inc | Preparation of functional human factor viii and dna sequences,expression vectors,transformed microorganisms and cell lines used therein |
| US4743680A (en) * | 1985-02-01 | 1988-05-10 | New York University | Method for purifying antihemophilic factor |
| SE8501050D0 (sv) * | 1985-03-05 | 1985-03-05 | Kabivitrum Ab | Biologically active fragments of human antihemophilic factor and method for preparation thereof |
| US4758657A (en) * | 1985-07-11 | 1988-07-19 | Armour Pharmaceutical Company | Method of purifying Factor VIII:C |
| US5595886A (en) * | 1986-01-27 | 1997-01-21 | Chiron Corporation | Protein complexes having Factor VIII:C activity and production thereof |
| CA1339946C (en) * | 1987-03-31 | 1998-07-07 | Michael J. Griffith | Ultrapurification process for polypeptides |
| SE465222C5 (sv) * | 1989-12-15 | 1998-02-10 | Pharmacia & Upjohn Ab | Ett rekombinant, humant faktor VIII-derivat och förfarande för dess framställning |
| FR2662166A1 (fr) * | 1990-05-18 | 1991-11-22 | Fondation Nale Transfusion San | Procede de preparation de facteur viii de tres haute purete comprenant une etape rapide d'immunoadsorption. |
| GB9211538D0 (en) * | 1992-06-01 | 1992-07-15 | Blake David R | Antiinflammatory agent |
| DE69329795T2 (de) * | 1992-10-02 | 2001-07-05 | Genetics Institute, Inc. | Zusammensetzung, welche den koagulationsfaktor viii beinhaltet; verfahren zu deren herstellung und die benutzung eines oberflächenaktiven stoffes als stabilisator |
| AU6653094A (en) * | 1992-12-16 | 1994-07-04 | Immuno Aktiengesellschaft | Process for preparing a virus-safe biological composition |
-
1994
- 1994-11-14 SE SE9403914A patent/SE503424C2/sv not_active IP Right Cessation
-
1995
- 1995-11-14 NZ NZ295810A patent/NZ295810A/en not_active IP Right Cessation
- 1995-11-14 DK DK95937285T patent/DK0792281T3/da active
- 1995-11-14 AU AU39438/95A patent/AU691993B2/en not_active Expired
- 1995-11-14 AT AT95937285T patent/ATE225368T1/de active
- 1995-11-14 US US08/809,698 patent/US6005082A/en not_active Expired - Lifetime
- 1995-11-14 DE DE69528471T patent/DE69528471T2/de not_active Expired - Lifetime
- 1995-11-14 ES ES95937285T patent/ES2182915T3/es not_active Expired - Lifetime
- 1995-11-14 PT PT95937285T patent/PT792281E/pt unknown
- 1995-11-14 JP JP51599296A patent/JP3871710B2/ja not_active Expired - Lifetime
- 1995-11-14 WO PCT/SE1995/001350 patent/WO1996015140A1/en active IP Right Grant
- 1995-11-14 EP EP95937285A patent/EP0792281B1/en not_active Expired - Lifetime
Also Published As
| Publication number | Publication date |
|---|---|
| ATE225368T1 (de) | 2002-10-15 |
| DE69528471T2 (de) | 2003-07-10 |
| WO1996015140A1 (en) | 1996-05-23 |
| DE69528471D1 (de) | 2002-11-07 |
| AU3943895A (en) | 1996-06-06 |
| JPH10508841A (ja) | 1998-09-02 |
| SE503424C2 (sv) | 1996-06-10 |
| EP0792281A1 (en) | 1997-09-03 |
| PT792281E (pt) | 2003-02-28 |
| EP0792281B1 (en) | 2002-10-02 |
| AU691993B2 (en) | 1998-05-28 |
| NZ295810A (en) | 1998-08-26 |
| US6005082A (en) | 1999-12-21 |
| SE9403914L (sv) | 1996-05-15 |
| MX9703470A (es) | 1997-07-31 |
| JP3871710B2 (ja) | 2007-01-24 |
| SE9403914D0 (sv) | 1994-11-14 |
| DK0792281T3 (da) | 2003-02-03 |
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