CL2015002720A1 - Composición y kit farmacéutico de un polipéptido quimérico del factor viii y fc. - Google Patents
Composición y kit farmacéutico de un polipéptido quimérico del factor viii y fc.Info
- Publication number
- CL2015002720A1 CL2015002720A1 CL2015002720A CL2015002720A CL2015002720A1 CL 2015002720 A1 CL2015002720 A1 CL 2015002720A1 CL 2015002720 A CL2015002720 A CL 2015002720A CL 2015002720 A CL2015002720 A CL 2015002720A CL 2015002720 A1 CL2015002720 A1 CL 2015002720A1
- Authority
- CL
- Chile
- Prior art keywords
- composition
- factor viii
- chimeric polypeptide
- fviii
- pharmaceutical kit
- Prior art date
Links
Classifications
-
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
-
- 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
-
- 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
- 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)
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2803—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
- C07K16/2833—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily against MHC-molecules, e.g. HLA-molecules
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2319/00—Fusion polypeptide
- C07K2319/30—Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Immunology (AREA)
- Hematology (AREA)
- Pharmacology & Pharmacy (AREA)
- Engineering & Computer Science (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Gastroenterology & Hepatology (AREA)
- Zoology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Molecular Biology (AREA)
- Biophysics (AREA)
- Biochemistry (AREA)
- Genetics & Genomics (AREA)
- Epidemiology (AREA)
- Diabetes (AREA)
- Toxicology (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Peptides Or Proteins (AREA)
- Medicinal Preparation (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
Abstract
La invención describe una composición farmacéutica que comprende un polipéptido FVIII, particularmente una proteína de fusión que comprende FVIII recombinante sin el dominio B y una región Fc, más los excipientes: sacarosa, cloruro de sodio, L-histidina, cloruro de calcio dihidratado y polisorbato 80 o 20. También reivindica un kit que comprende un primer recipiente que comprende polvo liofilizado con FVIII y un segundo recipiente agua esterilizada con un volumen suficiente cuando se combina con el polvo liofilizado del primer recipiente una composición que comprende FVIII recombinante sin el dominio B y una región Fc, sacarosa, cloruro de sodio, L-histidina, cloruro de calcio dihidratado y polisorbato 80 o 20.
Applications Claiming Priority (8)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201361800293P | 2013-03-15 | 2013-03-15 | |
| US201361817085P | 2013-04-29 | 2013-04-29 | |
| US201361829884P | 2013-05-31 | 2013-05-31 | |
| US201361839477P | 2013-06-26 | 2013-06-26 | |
| US201361863860P | 2013-08-08 | 2013-08-08 | |
| US201361876927P | 2013-09-12 | 2013-09-12 | |
| US201361879955P | 2013-09-19 | 2013-09-19 | |
| US201361897742P | 2013-10-30 | 2013-10-30 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CL2015002720A1 true CL2015002720A1 (es) | 2016-11-04 |
Family
ID=50771579
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CL2015002720A CL2015002720A1 (es) | 2013-03-15 | 2015-09-15 | Composición y kit farmacéutico de un polipéptido quimérico del factor viii y fc. |
Country Status (21)
| Country | Link |
|---|---|
| US (3) | US9623088B2 (es) |
| EP (3) | EP4122487A1 (es) |
| JP (5) | JP6330026B2 (es) |
| AU (3) | AU2014228506A1 (es) |
| CA (1) | CA2899737A1 (es) |
| CL (1) | CL2015002720A1 (es) |
| DK (1) | DK2968477T3 (es) |
| EA (2) | EA030357B1 (es) |
| ES (2) | ES2926798T3 (es) |
| HK (1) | HK1220617A1 (es) |
| HU (1) | HUE047933T2 (es) |
| LT (1) | LT2968477T (es) |
| PH (2) | PH12015501801A1 (es) |
| PL (2) | PL3666283T3 (es) |
| PT (2) | PT2968477T (es) |
| RS (1) | RS60003B1 (es) |
| SG (2) | SG11201505924TA (es) |
| SI (1) | SI2968477T1 (es) |
| TW (2) | TWI629993B (es) |
| UY (1) | UY35462A (es) |
| WO (1) | WO2014144795A1 (es) |
Families Citing this family (18)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CA2782424C (en) * | 2009-12-06 | 2021-07-27 | Biogen Idec Hemophilia Inc. | Factor viii-fc chimeric and hybrid polypeptides, and methods of use thereof |
| TWI788044B (zh) | 2013-03-15 | 2022-12-21 | 美商百歐維拉提夫治療公司 | 因子ｉｘ多肽調配物 |
| TWI629993B (zh) * | 2013-03-15 | 2018-07-21 | 美商生物化學醫療公司 | 因子ｖｉｉｉ多肽調配物 |
| CN106279437B (zh) * | 2016-08-19 | 2017-10-31 | 安源医药科技（上海）有限公司 | 高糖基化人凝血因子viii融合蛋白及其制备方法与用途 |
| CN107759696A (zh) | 2016-08-19 | 2018-03-06 | 安源医药科技（上海）有限公司 | 人白介素7融合蛋白及其制备方法 |
| IL308416A (en) | 2016-12-02 | 2024-01-01 | Bioverativ Therapeutics Inc | Methods for the treatment of hemophilic arthritis with the help of chimeric blood coagulation factors |
| KR20190091292A (ko) | 2016-12-02 | 2019-08-05 | 바이오버라티브 테라퓨틱스 인크. | 응고 인자에 대한 면역 내성 유도 방법 |
| JP7039308B2 (ja) * | 2017-02-08 | 2022-03-22 | 三洋化成工業株式会社 | 細胞培養用担体 |
| SG11202000764RA (en) | 2017-08-09 | 2020-02-27 | Bioverativ Therapeutics Inc | Nucleic acid molecules and uses thereof |
| US10603275B2 (en) | 2017-11-07 | 2020-03-31 | Rani Therapeutics, Llc | Clotting factor preparations for delivery into tissue of the intestinal tract using a swallowable drug delivery device |
| JP2021523878A (ja) | 2018-05-18 | 2021-09-09 | 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 | 血友病ａを処置する方法 |
| JP2021533753A (ja) | 2018-08-09 | 2021-12-09 | 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 | 核酸分子及び非ウイルス遺伝子治療のためのそれらの使用 |
| CN113301911A (zh) * | 2018-10-23 | 2021-08-24 | 费城儿童医院 | 用于调节因子viii功能的组合物和方法 |
| JPWO2020175594A1 (es) * | 2019-02-28 | 2020-09-03 | ||
| MX2021012540A (es) | 2019-04-17 | 2022-01-18 | Codiak Biosciences Inc | Composiciones de exosomas y virus adenoasociados (aav). |
| AU2020298233A1 (en) | 2019-06-19 | 2022-01-20 | Bioverativ Therapeutics Inc. | Recombinant factor VIII-Fc for treating hemophilia and low bone mineral density |
| TW202400224A (zh) * | 2022-05-10 | 2024-01-01 | 南韓商綠十字股份有限公司 | 用於冷凍乾燥血漿蛋白之新穎液體調配物 |
| KR20230159284A (ko) * | 2022-05-10 | 2023-11-21 | 주식회사 녹십자 | 혈장 단백질에 대한 신규한 액상 제형물 |
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| US4757006A (en) | 1983-10-28 | 1988-07-12 | Genetics Institute, Inc. | Human factor VIII:C gene and recombinant methods for production |
| EP0154316B1 (en) | 1984-03-06 | 1989-09-13 | Takeda Chemical Industries, Ltd. | Chemically modified lymphokine and production thereof |
| US4965199A (en) | 1984-04-20 | 1990-10-23 | Genentech, Inc. | Preparation of functional human factor VIII in mammalian cells using methotrexate based selection |
| US4868112A (en) | 1985-04-12 | 1989-09-19 | Genetics Institute, Inc. | Novel procoagulant proteins |
| KR910006424B1 (ko) | 1985-08-21 | 1991-08-24 | 인코텍스 비.브이 | 편성브리프(brief) 제조방법 |
| WO1987004187A1 (en) | 1986-01-03 | 1987-07-16 | Genetics Institute, Inc. | METHOD FOR PRODUCING FACTOR VIII:c-TYPE PROTEINS |
| US5595886A (en) | 1986-01-27 | 1997-01-21 | Chiron Corporation | Protein complexes having Factor VIII:C activity and production thereof |
| US5543502A (en) | 1986-06-24 | 1996-08-06 | Novo Nordisk A/S | Process for producing a coagulation active complex of factor VIII fragments |
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| CA1331157C (en) | 1987-04-06 | 1994-08-02 | Randal J. Kaufman | Method for producing factor viii:c-type proteins |
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| US6346513B1 (en) | 1987-06-12 | 2002-02-12 | Baxter Trading Gmbh | Proteins with factor VIII activity: process for their preparation using genetically-engineered cells and pharmaceutical compositions containing them |
| IE69026B1 (en) | 1987-06-12 | 1996-08-07 | Immuno Ag | Novel proteins with factor VIII activity process for their preparation using genetically-engineered cells and pharmaceutical compositions containing them |
| DE3720246A1 (de) | 1987-06-19 | 1988-12-29 | Behringwerke Ag | Faktor viii:c-aehnliches molekuel mit koagulationsaktivitaet |
| FR2619314B1 (fr) | 1987-08-11 | 1990-06-15 | Transgene Sa | Analogue du facteur viii, procede de preparation et composition pharmaceutique le contenant |
| US4994371A (en) | 1987-08-28 | 1991-02-19 | Davie Earl W | DNA preparation of Christmas factor and use of DNA sequences |
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| EP1988922A4 (en) * | 2006-02-03 | 2010-06-02 | Medimmune Llc | PROTEIN FORMULATIONS |
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| EP2369005B1 (en) | 2007-06-21 | 2013-04-03 | Technische Universität München | Biological active proteins having increased in vivo and/or in vitro stability |
| US8239182B2 (en) | 2007-12-04 | 2012-08-07 | Spansion Llc | Data transmission system-on-chip memory model based validation |
| EP2242505A4 (en) | 2008-01-08 | 2012-03-07 | Biogenerix Ag | GLYCOCONJUGATION OF POLYPEPTIDES USING OLIGOSACCHARYLTRANSFERASES |
| CN102482340B (zh) * | 2009-04-06 | 2015-05-13 | 诺沃—诺迪斯克有限公司 | 因子viii蛋白向血小板的靶向递送 |
| CA2782424C (en) * | 2009-12-06 | 2021-07-27 | Biogen Idec Hemophilia Inc. | Factor viii-fc chimeric and hybrid polypeptides, and methods of use thereof |
| ES2722209T3 (es) * | 2011-07-08 | 2019-08-08 | Bioverativ Therapeutics Inc | Polipéptidos quiméricos e híbridos del Factor VIII, y métodos de uso de los mismos |
| US9394353B2 (en) | 2011-10-18 | 2016-07-19 | Csl Limited | Method for improving the stability of purified factor VIII after reconstitution |
| US20160000884A1 (en) * | 2012-08-13 | 2016-01-07 | Novo Nordisk A/S | Liquid Factor VIII Formulations |
| EP3943102A1 (en) * | 2012-10-30 | 2022-01-26 | Bioverativ Therapeutics Inc. | Methods of using fviii polypeptide |
| TWI629993B (zh) * | 2013-03-15 | 2018-07-21 | 美商生物化學醫療公司 | 因子ｖｉｉｉ多肽調配物 |
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2014
- 2014-03-14 TW TW103109616A patent/TWI629993B/zh active
- 2014-03-14 EA EA201591439A patent/EA030357B1/ru unknown
- 2014-03-14 PT PT147258164T patent/PT2968477T/pt unknown
- 2014-03-14 LT LTEP14725816.4T patent/LT2968477T/lt unknown
- 2014-03-14 RS RS20200243A patent/RS60003B1/sr unknown
- 2014-03-14 EP EP22176875.7A patent/EP4122487A1/en active Pending
- 2014-03-14 US US14/213,180 patent/US9623088B2/en active Active
- 2014-03-14 PL PL19212900.5T patent/PL3666283T3/pl unknown
- 2014-03-14 EP EP14725816.4A patent/EP2968477B1/en active Active
- 2014-03-14 TW TW107113370A patent/TWI690325B/zh active
- 2014-03-14 PT PT192129005T patent/PT3666283T/pt unknown
- 2014-03-14 JP JP2016503069A patent/JP6330026B2/ja active Active
- 2014-03-14 UY UY0001035462A patent/UY35462A/es not_active Application Discontinuation
- 2014-03-14 ES ES19212900T patent/ES2926798T3/es active Active
- 2014-03-14 SG SG11201505924TA patent/SG11201505924TA/en unknown
- 2014-03-14 EA EA201890671A patent/EA201890671A1/ru unknown
- 2014-03-14 HU HUE14725816A patent/HUE047933T2/hu unknown
- 2014-03-14 SI SI201431514T patent/SI2968477T1/sl unknown
- 2014-03-14 SG SG10201805207QA patent/SG10201805207QA/en unknown
- 2014-03-14 EP EP19212900.5A patent/EP3666283B1/en active Active
- 2014-03-14 ES ES14725816T patent/ES2776195T3/es active Active
- 2014-03-14 AU AU2014228506A patent/AU2014228506A1/en not_active Abandoned
- 2014-03-14 CA CA2899737A patent/CA2899737A1/en active Pending
- 2014-03-14 DK DK14725816.4T patent/DK2968477T3/da active
- 2014-03-14 WO PCT/US2014/029354 patent/WO2014144795A1/en active Application Filing
- 2014-03-14 PL PL14725816T patent/PL2968477T3/pl unknown
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2015
- 2015-08-14 PH PH12015501801A patent/PH12015501801A1/en unknown
- 2015-09-15 CL CL2015002720A patent/CL2015002720A1/es unknown
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2016
- 2016-07-20 HK HK16108672.0A patent/HK1220617A1/zh unknown
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2017
- 2017-03-09 US US15/455,043 patent/US10786554B2/en active Active
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2018
- 2018-04-23 JP JP2018082321A patent/JP2018123161A/ja not_active Ceased
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2019
- 2019-04-16 AU AU2019202656A patent/AU2019202656B2/en active Active
- 2019-10-30 PH PH12019502452A patent/PH12019502452A1/en unknown
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2020
- 2020-08-14 US US16/993,979 patent/US20210069300A1/en active Pending
- 2020-08-19 JP JP2020138637A patent/JP6934994B2/ja active Active
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2021
- 2021-08-24 JP JP2021136162A patent/JP7240457B2/ja active Active
- 2021-11-29 AU AU2021277601A patent/AU2021277601A1/en active Pending
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2023
- 2023-03-03 JP JP2023032892A patent/JP2023060146A/ja active Pending
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