PL2337580T3 - Stabilizowane kompozycje czynnika VIII produkowanego metodami rekombinacji genetycznej - Google Patents
Stabilizowane kompozycje czynnika VIII produkowanego metodami rekombinacji genetycznejInfo
- Publication number
- PL2337580T3 PL2337580T3 PL09782562T PL09782562T PL2337580T3 PL 2337580 T3 PL2337580 T3 PL 2337580T3 PL 09782562 T PL09782562 T PL 09782562T PL 09782562 T PL09782562 T PL 09782562T PL 2337580 T3 PL2337580 T3 PL 2337580T3
- Authority
- PL
- Poland
- Prior art keywords
- factor viii
- recombinantly produced
- stabilized compositions
- produced factor
- stabilized
- Prior art date
Links
- 229960000301 factor viii Drugs 0.000 title abstract 5
- 239000000203 mixture Substances 0.000 title abstract 2
- 102000001690 Factor VIII Human genes 0.000 abstract 3
- 108010054218 Factor VIII Proteins 0.000 abstract 3
- 239000004475 Arginine Substances 0.000 abstract 1
- UXVMQQNJUSDDNG-UHFFFAOYSA-L Calcium chloride Chemical compound [Cl-].[Cl-].[Ca+2] UXVMQQNJUSDDNG-UHFFFAOYSA-L 0.000 abstract 1
- 229930006000 Sucrose Natural products 0.000 abstract 1
- 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 1
- ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 0.000 abstract 1
- 229910001628 calcium chloride Inorganic materials 0.000 abstract 1
- 239000001110 calcium chloride Substances 0.000 abstract 1
- 238000001179 sorption measurement Methods 0.000 abstract 1
- 230000006641 stabilisation Effects 0.000 abstract 1
- 238000011105 stabilization Methods 0.000 abstract 1
- 239000005720 sucrose Substances 0.000 abstract 1
- 239000004094 surface-active agent Substances 0.000 abstract 1
Classifications
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- 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
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
-
- 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
-
- 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
- A61K38/38—Albumins
-
- 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
- A61K47/02—Inorganic compounds
-
- 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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- 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
- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
-
- 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
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
-
- 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)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Gastroenterology & Hepatology (AREA)
- Immunology (AREA)
- Zoology (AREA)
- Hematology (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Dermatology (AREA)
- Inorganic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Diabetes (AREA)
- Organic Chemistry (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
- Micro-Organisms Or Cultivation Processes Thereof (AREA)
- Peptides Or Proteins (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US13640208P | 2008-09-03 | 2008-09-03 | |
| EP08163554 | 2008-09-03 | ||
| PCT/EP2009/061402 WO2010026186A1 (en) | 2008-09-03 | 2009-09-03 | New protecting compositions for recombinantly produced factor viii |
| EP09782562A EP2337580B1 (en) | 2008-09-03 | 2009-09-03 | Stabilized compositions for recombinantly produced factor viii |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| PL2337580T3 true PL2337580T3 (pl) | 2012-08-31 |
Family
ID=39791048
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PL09782562T PL2337580T3 (pl) | 2008-09-03 | 2009-09-03 | Stabilizowane kompozycje czynnika VIII produkowanego metodami rekombinacji genetycznej |
Country Status (19)
| Country | Link |
|---|---|
| US (4) | US20110178019A1 (pl) |
| EP (1) | EP2337580B1 (pl) |
| JP (2) | JP5960990B2 (pl) |
| KR (3) | KR20110073434A (pl) |
| CN (3) | CN102143759A (pl) |
| AT (1) | ATE551050T1 (pl) |
| AU (1) | AU2009289212B2 (pl) |
| BR (1) | BRPI0918589B1 (pl) |
| CA (1) | CA2735376C (pl) |
| DK (1) | DK2337580T3 (pl) |
| ES (1) | ES2382443T3 (pl) |
| IL (1) | IL211083A (pl) |
| MX (1) | MX2011002316A (pl) |
| PL (1) | PL2337580T3 (pl) |
| PT (1) | PT2337580E (pl) |
| RU (1) | RU2510279C3 (pl) |
| SI (1) | SI2337580T1 (pl) |
| WO (1) | WO2010026186A1 (pl) |
| ZA (1) | ZA201101605B (pl) |
Families Citing this family (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| PT2193809E (pt) | 1999-02-22 | 2015-08-24 | Baxter Int | Formulações de fator viii livres de albumina |
| BRPI0921429B1 (pt) * | 2008-11-07 | 2022-07-12 | Takeda Pharmaceutical Company Limited | Formulação farmacêutica liofilizada estável, e, método para preparar um fator liofilizado estável |
| CN102232932B (zh) * | 2010-04-27 | 2013-06-05 | 重庆莱美药业股份有限公司 | 果胶-阿霉素轭合物的冻干制剂及制备方法 |
| CN114848614A (zh) * | 2013-07-18 | 2022-08-05 | 曼金德公司 | 热稳定性干粉药物组合物和方法 |
| CA2934705C (en) | 2014-01-20 | 2020-03-31 | Octapharma Ag | A process for manufacturing factor viii having an improved ratio of fviii:c/fviii:ag |
| NZ729629A (en) * | 2014-08-04 | 2021-12-24 | Csl Ltd | Factor viii formulation |
| CA2961739C (en) * | 2014-08-20 | 2024-04-30 | Portola Pharmaceuticals, Inc. | Lyophilized formulations for factor xa antidote |
| CN108883160B (zh) * | 2016-02-24 | 2022-06-28 | 博尔托拉制药公司 | 因子xa解毒剂的冻干制剂 |
| ES2962373T3 (es) * | 2016-04-13 | 2024-03-18 | Medimmune Llc | Uso de aminoácidos como compuestos estabilizadores en composiciones farmacéuticas que contienen altas concentraciones de agentes terapéuticos basados en proteínas |
| US20220305089A1 (en) | 2019-08-16 | 2022-09-29 | Octapharma Ag | Stabilizing buffer for factor viii and vwf |
| CN116479088B (zh) * | 2022-11-15 | 2024-11-05 | 江苏默乐生物科技股份有限公司 | 一种生物试剂冻干保存的试剂组合、试剂盒、方法及应用 |
Family Cites Families (23)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5605884A (en) * | 1987-10-29 | 1997-02-25 | Rhone-Poulenc Rorer Pharmaceuticals Inc. | Factor VIII formulations in high ionic strength media |
| US4877608A (en) * | 1987-11-09 | 1989-10-31 | Rorer Pharmaceutical Corporation | Pharmaceutical plasma protein formulations in low ionic strength media |
| DE4001451A1 (de) * | 1990-01-19 | 1991-08-01 | Octapharma Ag | Stabile injizierbare loesungen von faktor viii und faktor ix |
| DE4111393A1 (de) * | 1991-04-09 | 1992-10-15 | Behringwerke Ag | Stabilisierte faktor viii-praeparationen |
| US5288853A (en) * | 1992-04-30 | 1994-02-22 | Alpha Therapeutic Corporation | Factor viii purification process |
| CZ290342B6 (cs) * | 1992-10-02 | 2002-07-17 | Genetics Institute Inc. | Kompozice stabilní při skladování, obsahující koagulační faktor VIII a neiontovou povrchově aktivní látku a způsob její výroby |
| SE9301581D0 (sv) * | 1993-05-07 | 1993-05-07 | Kabi Pharmacia Ab | Protein formulation |
| SE9403915D0 (sv) * | 1994-11-14 | 1994-11-14 | Annelie Almstedt | Process A |
| US5763401A (en) * | 1996-07-12 | 1998-06-09 | Bayer Corporation | Stabilized albumin-free recombinant factor VIII preparation having a low sugar content |
| US6005007A (en) * | 1997-07-18 | 1999-12-21 | Farmer; Luc J. | Retinoids, methods for their production and use |
| US6358703B1 (en) * | 1998-12-10 | 2002-03-19 | Bayer Corporation | Expression system for factor VIII |
| PT2193809E (pt) * | 1999-02-22 | 2015-08-24 | Baxter Int | Formulações de fator viii livres de albumina |
| AU6558400A (en) * | 1999-08-17 | 2001-03-13 | Novo Nordisk A/S | Stabilisation of freeze-dried cake |
| SE0004086D0 (sv) * | 2000-11-08 | 2000-11-08 | Pharmacia Ab | Preparation process |
| GB0207092D0 (en) * | 2002-03-26 | 2002-05-08 | Sod Conseils Rech Applic | Stable pharmaceutical composition containing factor VIII |
| CA2517310C (en) * | 2003-02-28 | 2015-11-24 | Chugai Seiyaku Kabushiki Kaisha | Stabilized protein-containing formulations comprising a poloxamer |
| KR100624013B1 (ko) * | 2004-06-25 | 2006-09-19 | 주식회사 녹십자홀딩스 | 동결건조된 알부민 비함유 재조합 사람 혈액응고 제 8인자 제제 |
| WO2006103298A2 (en) * | 2005-04-01 | 2006-10-05 | Novo Nordisk Health Care Ag | Blood coagulation fviii analogues |
| CN101415445A (zh) * | 2006-03-31 | 2009-04-22 | 巴克斯特国际公司 | 聚乙二醇化的因子ⅷ |
| WO2008073620A2 (en) * | 2006-11-02 | 2008-06-19 | Neose Technologies, Inc. | Manufacturing process for the production of polypeptides expressed in insect cell-lines |
| US20110014676A1 (en) * | 2007-06-29 | 2011-01-20 | Battelle Memorial Institute | Protein stabilization |
| EP2300497B1 (en) * | 2008-06-24 | 2012-08-08 | Octapharma AG | A process of purifying coagulation factor viii |
| US20110236412A1 (en) * | 2008-09-24 | 2011-09-29 | Stabilitech Ltd. | Method for Preserving Polypeptides Using a Sugar and Polyethyleneimine |
-
2009
- 2009-09-03 AT AT09782562T patent/ATE551050T1/de active
- 2009-09-03 BR BRPI0918589-5A patent/BRPI0918589B1/pt active IP Right Grant
- 2009-09-03 US US13/061,830 patent/US20110178019A1/en not_active Abandoned
- 2009-09-03 DK DK09782562.4T patent/DK2337580T3/da active
- 2009-09-03 PT PT09782562T patent/PT2337580E/pt unknown
- 2009-09-03 CN CN2009801343701A patent/CN102143759A/zh active Pending
- 2009-09-03 ES ES09782562T patent/ES2382443T3/es active Active
- 2009-09-03 JP JP2011525549A patent/JP5960990B2/ja active Active
- 2009-09-03 SI SI200930256T patent/SI2337580T1/sl unknown
- 2009-09-03 MX MX2011002316A patent/MX2011002316A/es active IP Right Grant
- 2009-09-03 CA CA2735376A patent/CA2735376C/en active Active
- 2009-09-03 KR KR1020117004838A patent/KR20110073434A/ko not_active Abandoned
- 2009-09-03 KR KR1020167021117A patent/KR101691443B1/ko not_active Expired - Fee Related
- 2009-09-03 KR KR1020167026077A patent/KR101691070B1/ko active Active
- 2009-09-03 CN CN201610936412.5A patent/CN107049964B/zh not_active Expired - Fee Related
- 2009-09-03 AU AU2009289212A patent/AU2009289212B2/en active Active
- 2009-09-03 PL PL09782562T patent/PL2337580T3/pl unknown
- 2009-09-03 CN CN201710068101.6A patent/CN107050437A/zh active Pending
- 2009-09-03 RU RU2011112787A patent/RU2510279C3/ru active Protection Beyond IP Right Term
- 2009-09-03 EP EP09782562A patent/EP2337580B1/en active Active
- 2009-09-03 WO PCT/EP2009/061402 patent/WO2010026186A1/en not_active Ceased
-
2011
- 2011-02-06 IL IL211083A patent/IL211083A/en active IP Right Grant
- 2011-03-02 ZA ZA2011/01605A patent/ZA201101605B/en unknown
-
2014
- 2014-12-11 US US14/567,065 patent/US20150190478A1/en not_active Abandoned
-
2015
- 2015-02-20 JP JP2015031889A patent/JP6010155B2/ja not_active Expired - Fee Related
-
2017
- 2017-03-20 US US15/463,049 patent/US20170189494A1/en not_active Abandoned
-
2018
- 2018-12-20 US US16/226,804 patent/US20190358301A1/en not_active Abandoned
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