DE69630291D1 - Proteinformulierung, die koajulationsfehler viii oder ix in einer saccharose wässriger lösung enthält - Google Patents
Proteinformulierung, die koajulationsfehler viii oder ix in einer saccharose wässriger lösung enthältInfo
- Publication number
- DE69630291D1 DE69630291D1 DE69630291T DE69630291T DE69630291D1 DE 69630291 D1 DE69630291 D1 DE 69630291D1 DE 69630291 T DE69630291 T DE 69630291T DE 69630291 T DE69630291 T DE 69630291T DE 69630291 D1 DE69630291 D1 DE 69630291D1
- Authority
- DE
- Germany
- Prior art keywords
- solution
- aqueous solution
- pct
- viii
- concentration
- 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
- 239000007864 aqueous solution Substances 0.000 title abstract 3
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 title 1
- 229930006000 Sucrose Natural products 0.000 title 1
- 235000013681 dietary sucrose Nutrition 0.000 title 1
- 238000009472 formulation Methods 0.000 title 1
- 239000000203 mixture Substances 0.000 title 1
- 102000004169 proteins and genes Human genes 0.000 title 1
- 108090000623 proteins and genes Proteins 0.000 title 1
- 229960004793 sucrose Drugs 0.000 title 1
- 239000000243 solution Substances 0.000 abstract 5
- 102000013831 Coagulation factor IX Human genes 0.000 abstract 2
- 108010076282 Factor IX Proteins 0.000 abstract 2
- 108010054218 Factor VIII Proteins 0.000 abstract 2
- 102000001690 Factor VIII Human genes 0.000 abstract 2
- 239000003963 antioxidant agent Substances 0.000 abstract 2
- 230000003078 antioxidant effect Effects 0.000 abstract 2
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 abstract 2
- 150000001720 carbohydrates Chemical class 0.000 abstract 2
- 229940105774 coagulation factor ix Drugs 0.000 abstract 2
- 229940105778 coagulation factor viii Drugs 0.000 abstract 2
- 229940126534 drug product Drugs 0.000 abstract 2
- 229910052760 oxygen Inorganic materials 0.000 abstract 2
- 239000001301 oxygen Substances 0.000 abstract 2
- 239000000825 pharmaceutical preparation Substances 0.000 abstract 2
- 108010017384 Blood Proteins Proteins 0.000 abstract 1
- 102000004506 Blood Proteins Human genes 0.000 abstract 1
- 230000007774 longterm Effects 0.000 abstract 1
- 238000004519 manufacturing process Methods 0.000 abstract 1
- 238000000034 method Methods 0.000 abstract 1
- 230000004952 protein activity Effects 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
- 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
- A61K38/43—Enzymes; Proenzymes; Derivatives thereof
- A61K38/46—Hydrolases (3)
- A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
- A61K38/482—Serine endopeptidases (3.4.21)
- A61K38/4846—Factor VII (3.4.21.21); Factor IX (3.4.21.22); Factor Xa (3.4.21.6); Factor XI (3.4.21.27); Factor XII (3.4.21.38)
-
- 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
-
- 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
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S530/00—Chemistry: natural resins or derivatives; peptides or proteins; lignins or reaction products thereof
- Y10S530/827—Proteins from mammals or birds
- Y10S530/829—Blood
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S530/00—Chemistry: natural resins or derivatives; peptides or proteins; lignins or reaction products thereof
- Y10S530/827—Proteins from mammals or birds
- Y10S530/829—Blood
- Y10S530/83—Plasma; serum
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Gastroenterology & Hepatology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Public Health (AREA)
- Engineering & Computer Science (AREA)
- Immunology (AREA)
- Epidemiology (AREA)
- Zoology (AREA)
- Hematology (AREA)
- Organic Chemistry (AREA)
- Biochemistry (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Molecular Biology (AREA)
- Toxicology (AREA)
- Diabetes (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Peptides Or Proteins (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| SE9501189A SE9501189D0 (sv) | 1995-03-31 | 1995-03-31 | Protein formulation |
| SE9501189 | 1995-03-31 | ||
| PCT/SE1996/000419 WO1996030041A1 (en) | 1995-03-31 | 1996-03-29 | Protein formulation comprising coagulation factor viii or factor ix in an aqueous solution |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| DE69630291D1 true DE69630291D1 (de) | 2003-11-13 |
| DE69630291T2 DE69630291T2 (de) | 2004-05-06 |
Family
ID=20397788
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DE69630291T Expired - Lifetime DE69630291T2 (de) | 1995-03-31 | 1996-03-29 | Proteinformulierung, die koajulationsfehler viii oder ix in einer saccharose wässriger lösung enthält |
Country Status (14)
| Country | Link |
|---|---|
| US (1) | US5919908A (de) |
| EP (1) | EP0819010B1 (de) |
| JP (1) | JP3953102B2 (de) |
| AT (1) | ATE251467T1 (de) |
| AU (1) | AU709642B2 (de) |
| BR (1) | BR9607922A (de) |
| CA (1) | CA2216098C (de) |
| DE (1) | DE69630291T2 (de) |
| DK (1) | DK0819010T3 (de) |
| ES (1) | ES2208736T3 (de) |
| NZ (1) | NZ305028A (de) |
| PT (1) | PT819010E (de) |
| SE (1) | SE9501189D0 (de) |
| WO (1) | WO1996030041A1 (de) |
Families Citing this family (24)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5763401A (en) * | 1996-07-12 | 1998-06-09 | Bayer Corporation | Stabilized albumin-free recombinant factor VIII preparation having a low sugar content |
| US20030190307A1 (en) | 1996-12-24 | 2003-10-09 | Biogen, Inc. | Stable liquid interferon formulations |
| ATE365052T1 (de) * | 1999-02-22 | 2007-07-15 | Univ Connecticut | Neue albuminfreie faktor viii formulierungen |
| JP2003522735A (ja) * | 1999-07-15 | 2003-07-29 | ジェネティクス インスティチュート，エルエルシー | Ｉｌ−１１に関する組成物 |
| ES2650593T3 (es) * | 2001-11-29 | 2018-01-19 | Godo Kaisha Ip Bridge 1 | Método de extracción de la distorsión de codificación |
| US20040127537A1 (en) * | 2002-06-26 | 2004-07-01 | Gokarn Yatin R. | Stable liquid parenteral parecoxib formulation |
| DE10261126A1 (de) | 2002-08-13 | 2004-03-04 | Aventis Behring Gmbh | Lagerungsstabile, flüssige Fibrinogen-Formulierung |
| JP2006515882A (ja) * | 2003-01-08 | 2006-06-08 | カイロン コーポレイション | 組織因子経路インヒビター（ｔｆｐｉ）または組織因子経路インヒビター改変体を含有する安定化水性組成物 |
| DE602004015755D1 (de) * | 2003-03-31 | 2008-09-25 | Alza Corp | Nicht wässrige einphasige visköse vehikel und formulierungen die diese vehikel verwenden |
| ES2229931B1 (es) * | 2003-10-03 | 2006-01-16 | Grifols, S.A. | Composicion liquida bilogicamente estable de fviii, de fvw o del complejo fviii/fvw humanos. |
| US20070105782A1 (en) * | 2005-10-07 | 2007-05-10 | Board Of Trustees Of Southern Illinois University | Protectant Combinations for Reducing Toxicities |
| PT2222315E (pt) * | 2007-12-21 | 2013-07-16 | Cangene Corp | Formulações de fator ix estabilizadas contendo trealose |
| EP2113564A1 (de) | 2008-05-01 | 2009-11-04 | Arecor Limited | Proteinformulierung |
| RU2011110459A (ru) | 2008-08-21 | 2012-09-27 | Октафарма АГ (CH) | Рекомбинантно полученный человеческий фактор viii и ix |
| JP5779780B2 (ja) * | 2008-11-07 | 2015-09-16 | バクスター・インターナショナル・インコーポレイテッドＢａｘｔｅｒ Ｉｎｔｅｒｎａｔｉｏｎａｌ Ｉｎｃｏｒｐ０Ｒａｔｅｄ | 第ｖｉｉｉ因子製剤 |
| GB0915481D0 (en) * | 2009-09-04 | 2009-10-07 | Arecor Ltd | Stable manufacture of factor V111 |
| GB0915480D0 (en) * | 2009-09-04 | 2009-10-07 | Arecor Ltd | Stable formulation of factor viii |
| WO2011104552A1 (en) * | 2010-02-24 | 2011-09-01 | Arecor Limited | Stable compositions of factor ix |
| EP2361636A1 (de) | 2010-02-26 | 2011-08-31 | CSL Behring AG | Immunglobulinpräparat und Aufbewahrungssystem für ein Immunglobulinpräparat |
| JP2019043961A (ja) * | 2010-04-20 | 2019-03-22 | オクタファルマ・アーゲー | 医薬タンパク質の新規な安定化剤 |
| KR101872203B1 (ko) | 2010-04-20 | 2018-08-02 | 옥타파마 아게 | 약학 단백질을 위한 신규한 안정화제 |
| SG11201700550YA (en) | 2014-08-04 | 2017-02-27 | Csl Ltd | Factor viii formulation |
| KR20220029733A (ko) | 2019-07-04 | 2022-03-08 | 체에스엘 베링 렝나우 아게 | 응고 인자 viii의 시험관내 안정성을 증가시키기 위한 절단된 폰 빌레브란트 인자 (vwf) |
| US20220380439A1 (en) | 2020-11-09 | 2022-12-01 | Takeda Pharmaceutical Company Limited | Purification of fviii from plasma using silicon oxide adsorption |
Family Cites Families (14)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE2916711A1 (de) * | 1979-04-25 | 1980-11-06 | Behringwerke Ag | Blutgerinnungsfaktoren und verfahren zu ihrer herstellung |
| US4447416A (en) * | 1982-04-28 | 1984-05-08 | American National Red Cross | Plasma protein concentrates of reduced thrombogenicity and their use in clinical replacement therapy |
| JPS59134730A (ja) * | 1983-01-20 | 1984-08-02 | Green Cross Corp:The | 血液凝固第８因子の加熱処理法 |
| SE8501050D0 (sv) * | 1985-03-05 | 1985-03-05 | Kabivitrum Ab | Biologically active fragments of human antihemophilic factor and method for preparation thereof |
| DE3682047D1 (de) * | 1985-07-09 | 1991-11-21 | Quadrant Bioresources Ltd | Beschuetzung von proteinen und aehnlichem. |
| SE465222C5 (sv) * | 1989-12-15 | 1998-02-10 | Pharmacia & Upjohn Ab | Ett rekombinant, humant faktor VIII-derivat och förfarande för dess framställning |
| DE4001451A1 (de) * | 1990-01-19 | 1991-08-01 | Octapharma Ag | Stabile injizierbare loesungen von faktor viii und faktor ix |
| GB9010742D0 (en) * | 1990-05-14 | 1990-07-04 | Quadrant Bioresources Ltd | Stabilization of biological macromolecular substances |
| FR2687317B1 (fr) * | 1992-02-13 | 1995-06-23 | Aetsrn | Composition pour stabiliser le plasma sanguin en cour de pasteurisation et solution plasmatique pasteurisee a usage therapeutique. |
| DE4205192C2 (de) * | 1992-02-20 | 1995-10-12 | Euka Bauelemente Verkaufsgesel | Bahnsteig |
| KR100303872B1 (ko) * | 1992-10-02 | 2001-11-22 | 크리스터 발스트룀, 프레드릭 베르그, 하랄트 알름 | 응고인자ⅷ제형을포함하는조성물,이것의제조방법및안정화제로서의계면활성제의사용방법 |
| EP0683678B1 (de) * | 1993-02-09 | 1998-07-15 | Octapharma Ag | Verfahren zur inaktivierung von viren, die nicht mit lipidhüllen versehen sind |
| SE9301581D0 (sv) * | 1993-05-07 | 1993-05-07 | Kabi Pharmacia Ab | Protein formulation |
| US5576291A (en) * | 1993-09-13 | 1996-11-19 | Baxter International Inc. | Activated factor VIII as a therapeutic agent and method of treating factor VIII deficiency |
-
1995
- 1995-03-31 SE SE9501189A patent/SE9501189D0/xx unknown
-
1996
- 1996-03-09 US US08/913,263 patent/US5919908A/en not_active Expired - Lifetime
- 1996-03-29 DE DE69630291T patent/DE69630291T2/de not_active Expired - Lifetime
- 1996-03-29 BR BR9607922A patent/BR9607922A/pt not_active Application Discontinuation
- 1996-03-29 WO PCT/SE1996/000419 patent/WO1996030041A1/en active IP Right Grant
- 1996-03-29 EP EP96909444A patent/EP0819010B1/de not_active Expired - Lifetime
- 1996-03-29 AU AU52934/96A patent/AU709642B2/en not_active Ceased
- 1996-03-29 DK DK96909444T patent/DK0819010T3/da active
- 1996-03-29 PT PT96909444T patent/PT819010E/pt unknown
- 1996-03-29 CA CA2216098A patent/CA2216098C/en not_active Expired - Fee Related
- 1996-03-29 AT AT96909444T patent/ATE251467T1/de active
- 1996-03-29 NZ NZ305028A patent/NZ305028A/en not_active IP Right Cessation
- 1996-03-29 JP JP52928396A patent/JP3953102B2/ja not_active Expired - Fee Related
- 1996-03-29 ES ES96909444T patent/ES2208736T3/es not_active Expired - Lifetime
Also Published As
| Publication number | Publication date |
|---|---|
| NZ305028A (en) | 1998-08-26 |
| ES2208736T3 (es) | 2004-06-16 |
| AU709642B2 (en) | 1999-09-02 |
| PT819010E (pt) | 2004-01-30 |
| US5919908A (en) | 1999-07-06 |
| EP0819010A1 (de) | 1998-01-21 |
| CA2216098A1 (en) | 1996-10-03 |
| JPH11502833A (ja) | 1999-03-09 |
| SE9501189D0 (sv) | 1995-03-31 |
| CA2216098C (en) | 2011-08-23 |
| DK0819010T3 (da) | 2004-02-09 |
| JP3953102B2 (ja) | 2007-08-08 |
| AU5293496A (en) | 1996-10-16 |
| ATE251467T1 (de) | 2003-10-15 |
| EP0819010B1 (de) | 2003-10-08 |
| WO1996030041A1 (en) | 1996-10-03 |
| BR9607922A (pt) | 1998-06-09 |
| DE69630291T2 (de) | 2004-05-06 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| 8364 | No opposition during term of opposition |