DK0511234T3 - Stabil injicerbar opløsning af faktor VIII - Google Patents
Stabil injicerbar opløsning af faktor VIIIInfo
- Publication number
- DK0511234T3 DK0511234T3 DK91901746.7T DK91901746T DK0511234T3 DK 0511234 T3 DK0511234 T3 DK 0511234T3 DK 91901746 T DK91901746 T DK 91901746T DK 0511234 T3 DK0511234 T3 DK 0511234T3
- Authority
- DK
- Denmark
- Prior art keywords
- factor viii
- injectable solution
- stable injectable
- stable
- concentrations
- Prior art date
Links
- 102000001690 Factor VIII Human genes 0.000 title abstract 3
- 108010054218 Factor VIII Proteins 0.000 title abstract 3
- 229960000301 factor viii Drugs 0.000 title abstract 3
- 229940102223 injectable solution Drugs 0.000 title abstract 2
- 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 abstract 2
- 229930006000 Sucrose Natural products 0.000 abstract 2
- 150000001413 amino acids Chemical class 0.000 abstract 2
- 235000013681 dietary sucrose Nutrition 0.000 abstract 2
- 150000002016 disaccharides Chemical class 0.000 abstract 2
- 229960004793 sucrose Drugs 0.000 abstract 2
- 238000004519 manufacturing process Methods 0.000 abstract 1
- 230000000087 stabilizing effect Effects 0.000 abstract 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- 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
-
- 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
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- 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
- 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)
-
- 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)
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Zoology (AREA)
- Organic Chemistry (AREA)
- Genetics & Genomics (AREA)
- Biochemistry (AREA)
- Wood Science & Technology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Hematology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Molecular Biology (AREA)
- Gastroenterology & Hepatology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- General Engineering & Computer Science (AREA)
- Immunology (AREA)
- Biomedical Technology (AREA)
- Dermatology (AREA)
- Biotechnology (AREA)
- Microbiology (AREA)
- Diabetes (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE4001451A DE4001451A1 (de) | 1990-01-19 | 1990-01-19 | Stabile injizierbare loesungen von faktor viii und faktor ix |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK0511234T3 true DK0511234T3 (da) | 1995-08-21 |
Family
ID=6398370
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK91901746.7T DK0511234T3 (da) | 1990-01-19 | 1990-12-19 | Stabil injicerbar opløsning af faktor VIII |
Country Status (8)
| Country | Link |
|---|---|
| US (1) | US5328694A (da) |
| EP (1) | EP0511234B1 (da) |
| JP (1) | JPH05504342A (da) |
| AT (1) | ATE120960T1 (da) |
| DE (2) | DE4001451A1 (da) |
| DK (1) | DK0511234T3 (da) |
| ES (1) | ES2071292T3 (da) |
| WO (1) | WO1991010439A1 (da) |
Families Citing this family (37)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE4111393A1 (de) * | 1991-04-09 | 1992-10-15 | Behringwerke Ag | Stabilisierte faktor viii-praeparationen |
| GB9122609D0 (en) * | 1991-10-24 | 1991-12-04 | Brownlee George G | Improvements relating to the treatment of haemophilia |
| CA2124690C (en) * | 1992-10-02 | 2007-09-11 | Thomas Osterberg | Composition comprising coagulation factor viii formulation, process for its preparation and use of a surfactant as stabilizer |
| SE9301581D0 (sv) * | 1993-05-07 | 1993-05-07 | Kabi Pharmacia Ab | Protein formulation |
| US6288030B1 (en) | 1993-12-22 | 2001-09-11 | Amgen Inc. | Stem cell factor formulations and methods |
| US6242417B1 (en) | 1994-03-08 | 2001-06-05 | Somatogen, Inc. | Stabilized compositions containing hemoglobin |
| IL113010A (en) * | 1994-03-31 | 1999-10-28 | Pharmacia & Upjohn Ab | Pharmaceutical formulation comprising factor viii with an activity of at least 500iu/ml and an enhancer for improved subcutaneous intramuscular or intradermal administration |
| US6372716B1 (en) * | 1994-04-26 | 2002-04-16 | Genetics Institute, Inc. | Formulations for factor IX |
| SE9501189D0 (sv) * | 1995-03-31 | 1995-03-31 | Pharmacia Ab | Protein formulation |
| US5770700A (en) * | 1996-01-25 | 1998-06-23 | Genetics Institute, Inc. | Liquid factor IX formulations |
| US5763401A (en) * | 1996-07-12 | 1998-06-09 | Bayer Corporation | Stabilized albumin-free recombinant factor VIII preparation having a low sugar content |
| DK1820516T3 (da) | 1999-02-22 | 2013-10-28 | Univ Connecticut | Nye albuminfrie faktor VIII-præparater |
| AU2002213441B2 (en) * | 2000-10-12 | 2006-10-26 | Genentech, Inc. | Reduced-viscosity concentrated protein formulations |
| US8703126B2 (en) | 2000-10-12 | 2014-04-22 | Genentech, Inc. | Reduced-viscosity concentrated protein formulations |
| EP1458408B1 (en) | 2001-12-21 | 2009-04-15 | Novo Nordisk Health Care AG | Liquid composition of factor vii polypeptides |
| CN1671410B (zh) | 2002-06-21 | 2010-05-12 | 诺和诺德医疗保健公司 | 因子ⅶ多肽的稳定化固体组合物 |
| US7897734B2 (en) | 2003-03-26 | 2011-03-01 | Novo Nordisk Healthcare Ag | Method for the production of proteins |
| MXPA05010555A (es) | 2003-04-04 | 2006-03-09 | Genentech Inc | Formulaciones de proteina y anticuerpo de alta concentracion. |
| RU2364609C2 (ru) | 2003-05-23 | 2009-08-20 | Ново Нордиск Хелт Кэр Аг | Стабилизация белка в растворе |
| EP1641487B1 (en) | 2003-06-25 | 2012-02-29 | Novo Nordisk Health Care AG | Liquid composition of factor vii polypeptides |
| JP5653572B2 (ja) | 2003-08-14 | 2015-01-14 | ノボ ノルディスク ヘルス ケア アクチェンゲゼルシャフト | 第vii因子ポリペプチドの液状水性医薬組成物 |
| CA2538794C (en) | 2003-09-12 | 2016-04-19 | Antigenics, Inc. | Vaccine for treatment and prevention of herpes simplex virus infection |
| CN1917861B (zh) | 2003-12-19 | 2012-03-21 | 诺和诺德医疗保健公司 | 因子vii多肽的稳定化固体组合物 |
| KR100624013B1 (ko) | 2004-06-25 | 2006-09-19 | 주식회사 녹십자홀딩스 | 동결건조된 알부민 비함유 재조합 사람 혈액응고 제 8인자 제제 |
| FI121025B (fi) * | 2004-12-07 | 2010-06-15 | Sandvik Mining & Constr Oy | Menetelmä putkiporaukseen, porausyksikkö sekä adapterilaite |
| CN101163506B (zh) | 2004-12-27 | 2012-09-26 | 巴克斯特国际公司 | 聚合物-von Willebrand因子偶联物 |
| AU2007245190B2 (en) * | 2006-03-31 | 2011-07-21 | Takeda Pharmaceutical Company Limited | Pegylated factor VIII |
| US7645860B2 (en) | 2006-03-31 | 2010-01-12 | Baxter Healthcare S.A. | Factor VIII polymer conjugates |
| MX2011001624A (es) | 2008-08-21 | 2011-03-28 | Octapharma Ag | Factor viii y ix humano producido en forma recombinante. |
| WO2010026186A1 (en) * | 2008-09-03 | 2010-03-11 | Octapharma Ag | New protecting compositions for recombinantly produced factor viii |
| MX339060B (es) | 2008-11-07 | 2016-05-09 | Baxter Int | Formulaciones del factor viii. |
| AU2010221156A1 (en) | 2009-03-06 | 2011-09-22 | Genentech, Inc. | Antibody formulation |
| CN106687126B (zh) | 2014-08-04 | 2020-07-28 | 杰特有限公司 | 因子viii制剂 |
| EA201792501A1 (ru) | 2015-05-13 | 2018-10-31 | Эйдженус Инк. | Вакцины для лечения и профилактики рака |
| MA52363A (fr) | 2018-04-26 | 2021-03-03 | Agenus Inc | Compositions peptidiques de liaison à une protéine de choc thermique (hsp) et leurs méthodes d'utilisation |
| WO2021001522A1 (en) | 2019-07-04 | 2021-01-07 | CSL Behring Lengnau AG | A truncated von willebrand factor (vwf) for increasing the in vitro stability of coagulation factor viii |
| JP2025512143A (ja) | 2020-11-09 | 2025-04-17 | 武田薬品工業株式会社 | 酸化ケイ素吸着を使用する血漿からのfviiiの精製 |
Family Cites Families (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4186192A (en) * | 1978-12-18 | 1980-01-29 | Cutter Laboratories, Inc. | Stabilized immune serum globulin |
| DE2916711A1 (de) * | 1979-04-25 | 1980-11-06 | Behringwerke Ag | Blutgerinnungsfaktoren und verfahren zu ihrer herstellung |
| EP0035204B2 (en) * | 1980-03-05 | 1991-05-22 | Miles Inc. | Pasteurized therapeutically active protein compositions |
| DE3045153A1 (de) * | 1980-11-29 | 1982-07-08 | Behringwerke Ag, 3550 Marburg | Verfahren zur herstellung von blutgerinnungsfaktoren und danach hergestellte praeparation der faktoren ix und x |
| US4495278A (en) * | 1981-04-27 | 1985-01-22 | Baxter Travenol Laboratories, Inc. | Process for making novel blood clotting enzyme compositions |
| JPS5874617A (ja) * | 1981-10-28 | 1983-05-06 | Green Cross Corp:The | 人由来血液凝固第7因子含有水溶液の加熱処理方法 |
| JPS58191881A (ja) * | 1982-05-01 | 1983-11-09 | 服部 盛義 | 自動車用ドア−の両開き装置 |
| DE3237512A1 (de) * | 1982-10-09 | 1984-04-12 | Behringwerke Ag, 3550 Marburg | Verfahren zur pasteurisierung von antihaemophilem kryopraezipitat (ahk) und danach hergestelltes antihaemophiles kryopraezipitat |
| JPS59112630A (ja) * | 1982-12-17 | 1984-06-29 | Matsushita Electric Ind Co Ltd | ワイヤボンデイング装置 |
| 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 |
| DE3336631A1 (de) * | 1983-10-08 | 1985-04-18 | Behringwerke Ag, 3550 Marburg | Verfahren zur pasteurisierung von plasma oder von konzentraten der blutgerinnungsfaktoren ii, vii, ix und x |
| DE3432083A1 (de) * | 1984-08-31 | 1986-03-06 | Behringwerke Ag, 3550 Marburg | Pasteurisierte, isoagglutininfreie faktor viii-praeparation und verfahren zu ihrer herstellung |
| US4847362A (en) * | 1985-02-01 | 1989-07-11 | New York University | Method for purifying antihemophilic factor |
| DE3625090A1 (de) * | 1986-07-24 | 1988-01-28 | Behringwerke Ag | Mittel zur therapie faktor viii-resistenter haemophilie a und verfahren zu seiner herstellung |
| CA1329760C (en) * | 1987-10-29 | 1994-05-24 | Ted C. K. Lee | Plasma and recombinant protein formulations in high ionic strength media |
| US5110907A (en) * | 1989-08-01 | 1992-05-05 | Alpha Therapeutic Corporation | Factor viii complex purification using heparin affinity chromatography |
-
1990
- 1990-01-19 DE DE4001451A patent/DE4001451A1/de not_active Ceased
- 1990-12-19 DE DE59008910T patent/DE59008910D1/de not_active Revoked
- 1990-12-19 ES ES91901746T patent/ES2071292T3/es not_active Expired - Lifetime
- 1990-12-19 JP JP91502059A patent/JPH05504342A/ja active Pending
- 1990-12-19 EP EP91901746A patent/EP0511234B1/de not_active Revoked
- 1990-12-19 AT AT91901746T patent/ATE120960T1/de not_active IP Right Cessation
- 1990-12-19 WO PCT/EP1990/002238 patent/WO1991010439A1/de not_active Ceased
- 1990-12-19 DK DK91901746.7T patent/DK0511234T3/da active
-
1992
- 1992-07-20 US US07/916,644 patent/US5328694A/en not_active Expired - Lifetime
Also Published As
| Publication number | Publication date |
|---|---|
| EP0511234A1 (de) | 1992-11-04 |
| JPH05504342A (ja) | 1993-07-08 |
| EP0511234B1 (de) | 1995-04-12 |
| ES2071292T3 (es) | 1995-06-16 |
| US5328694A (en) | 1994-07-12 |
| ATE120960T1 (de) | 1995-04-15 |
| DE4001451A1 (de) | 1991-08-01 |
| WO1991010439A1 (de) | 1991-07-25 |
| DE59008910D1 (de) | 1995-05-18 |
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