RU2015144076A - Композиции рекомбинантного фактора viii - Google Patents
Композиции рекомбинантного фактора viii Download PDFInfo
- Publication number
- RU2015144076A RU2015144076A RU2015144076A RU2015144076A RU2015144076A RU 2015144076 A RU2015144076 A RU 2015144076A RU 2015144076 A RU2015144076 A RU 2015144076A RU 2015144076 A RU2015144076 A RU 2015144076A RU 2015144076 A RU2015144076 A RU 2015144076A
- Authority
- RU
- Russia
- Prior art keywords
- range
- rfviii
- composition
- ppm
- present
- Prior art date
Links
- 239000000203 mixture Substances 0.000 title claims 18
- 229960000301 factor viii Drugs 0.000 title 1
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims 14
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 claims 10
- 239000011780 sodium chloride Substances 0.000 claims 7
- 239000002736 nonionic surfactant Substances 0.000 claims 6
- 239000004471 Glycine Substances 0.000 claims 5
- 150000001768 cations Chemical class 0.000 claims 5
- WCUXLLCKKVVCTQ-UHFFFAOYSA-M Potassium chloride Chemical compound [Cl-].[K+] WCUXLLCKKVVCTQ-UHFFFAOYSA-M 0.000 claims 4
- 229930006000 Sucrose Natural products 0.000 claims 4
- 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 claims 4
- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 claims 4
- 239000005720 sucrose Substances 0.000 claims 4
- 150000005846 sugar alcohols Chemical class 0.000 claims 4
- HDTRYLNUVZCQOY-UHFFFAOYSA-N α-D-glucopyranosyl-α-D-glucopyranoside Natural products OC1C(O)C(O)C(CO)OC1OC1C(O)C(O)C(O)C(CO)O1 HDTRYLNUVZCQOY-UHFFFAOYSA-N 0.000 claims 3
- 239000007993 MOPS buffer Substances 0.000 claims 3
- HDTRYLNUVZCQOY-WSWWMNSNSA-N Trehalose Natural products O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-WSWWMNSNSA-N 0.000 claims 3
- HDTRYLNUVZCQOY-LIZSDCNHSA-N alpha,alpha-trehalose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-LIZSDCNHSA-N 0.000 claims 3
- 125000000151 cysteine group Chemical group N[C@@H](CS)C(=O)* 0.000 claims 3
- 229920000642 polymer Polymers 0.000 claims 3
- 102100026735 Coagulation factor VIII Human genes 0.000 claims 2
- 101000911390 Homo sapiens Coagulation factor VIII Proteins 0.000 claims 2
- 150000001413 amino acids Chemical group 0.000 claims 2
- 238000000034 method Methods 0.000 claims 2
- 235000011164 potassium chloride Nutrition 0.000 claims 2
- 239000001103 potassium chloride Substances 0.000 claims 2
- 239000011541 reaction mixture Substances 0.000 claims 2
- HNDVDQJCIGZPNO-RXMQYKEDSA-N D-histidine Chemical compound OC(=O)[C@H](N)CC1=CN=CN1 HNDVDQJCIGZPNO-RXMQYKEDSA-N 0.000 claims 1
- 201000003542 Factor VIII deficiency Diseases 0.000 claims 1
- 208000009292 Hemophilia A Diseases 0.000 claims 1
- HNDVDQJCIGZPNO-YFKPBYRVSA-N L-histidine Chemical compound OC(=O)[C@@H](N)CC1=CN=CN1 HNDVDQJCIGZPNO-YFKPBYRVSA-N 0.000 claims 1
- 125000003277 amino group Chemical group 0.000 claims 1
- 229920000249 biocompatible polymer Polymers 0.000 claims 1
- 230000021615 conjugation Effects 0.000 claims 1
- 125000002924 primary amino group Chemical group [H]N([H])* 0.000 claims 1
- 125000000467 secondary amino group Chemical group [H]N([*:1])[*:2] 0.000 claims 1
- 239000000126 substance Substances 0.000 claims 1
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
- 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
- A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
-
- 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
- A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
- A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
- A61K47/56—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
- A61K47/59—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes
- A61K47/60—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
-
- 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)
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Hematology (AREA)
- Organic Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Gastroenterology & Hepatology (AREA)
- Zoology (AREA)
- Immunology (AREA)
- Toxicology (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Genetics & Genomics (AREA)
- General Chemical & Material Sciences (AREA)
- Biophysics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Inorganic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Diabetes (AREA)
- Medicinal Preparation (AREA)
- Peptides Or Proteins (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201361799495P | 2013-03-15 | 2013-03-15 | |
| US61/799,495 | 2013-03-15 | ||
| US201361869191P | 2013-08-23 | 2013-08-23 | |
| US61/869,191 | 2013-08-23 | ||
| PCT/US2014/023357 WO2014150477A1 (en) | 2013-03-15 | 2014-03-11 | Recombinant factor viii formulations |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| RU2015144076A true RU2015144076A (ru) | 2017-04-24 |
Family
ID=51580768
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2015144076A RU2015144076A (ru) | 2013-03-15 | 2014-03-11 | Композиции рекомбинантного фактора viii |
Country Status (17)
| Country | Link |
|---|---|
| US (1) | US20160030524A1 (https=) |
| EP (1) | EP2970430A4 (https=) |
| JP (1) | JP2016518321A (https=) |
| KR (1) | KR20150132449A (https=) |
| CN (1) | CN105209487A (https=) |
| AU (1) | AU2014237111B2 (https=) |
| BR (1) | BR112015022730A2 (https=) |
| CA (1) | CA2905739A1 (https=) |
| HK (1) | HK1213273A1 (https=) |
| MX (1) | MX2015012905A (https=) |
| PE (1) | PE20160121A1 (https=) |
| RU (1) | RU2015144076A (https=) |
| SG (2) | SG10201803999UA (https=) |
| TW (1) | TW201521761A (https=) |
| UY (1) | UY35412A (https=) |
| WO (1) | WO2014150477A1 (https=) |
| ZA (1) | ZA201507684B (https=) |
Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20190064147A1 (en) * | 2015-01-18 | 2019-02-28 | Biogen Ma Inc. | Formulations and screening of biological therapeutic agents |
| EA202190827A1 (ru) | 2015-11-13 | 2021-11-30 | Баксалта Инкорпорейтед | Вирусные векторы, кодирующие рекомбинантные варианты fviii с повышенной экспрессией для генной терапии гемофилии a |
| US12091675B2 (en) | 2018-07-16 | 2024-09-17 | Takeda Pharmaceutical Company Limited | Gene therapy of hemophilia a using viral vectors encoding recombinant FVIII variants with increased expression |
| TWI851647B (zh) | 2019-01-16 | 2024-08-11 | 日商武田藥品工業股份有限公司 | 用於a型血友病基因治療之編碼表現增加之重組fviii變異體的病毒載體 |
| US20220305089A1 (en) * | 2019-08-16 | 2022-09-29 | Octapharma Ag | Stabilizing buffer for factor viii and vwf |
Family Cites Families (9)
| 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 |
| KR20010101901A (ko) * | 1999-02-01 | 2001-11-15 | 모리 데쯔지 | 음극선관 및 그 제조방법 |
| DK1820516T3 (da) * | 1999-02-22 | 2013-10-28 | Univ Connecticut | Nye albuminfrie faktor VIII-præparater |
| ES2331909T3 (es) * | 2001-06-14 | 2010-01-20 | The Scripps Research Institute | Factor viii estabilizado con enlaces disulfuro modificados geneticamente. |
| GB0207092D0 (en) * | 2002-03-26 | 2002-05-08 | Sod Conseils Rech Applic | Stable pharmaceutical composition containing factor VIII |
| PT2363414T (pt) * | 2004-11-12 | 2022-08-04 | Bayer Healthcare Llc | Modificação de fviii direcionada a sítio |
| AU2007245190B2 (en) * | 2006-03-31 | 2011-07-21 | Takeda Pharmaceutical Company Limited | Pegylated factor VIII |
| MX339060B (es) * | 2008-11-07 | 2016-05-09 | Baxter Int | Formulaciones del factor viii. |
| US20120121613A1 (en) * | 2009-01-19 | 2012-05-17 | Bayer Healthcare Llc | Protein conjugate having an endopeptidase- cleavable bioprotective moiety |
-
2014
- 2014-03-11 SG SG10201803999UA patent/SG10201803999UA/en unknown
- 2014-03-11 MX MX2015012905A patent/MX2015012905A/es unknown
- 2014-03-11 HK HK16101334.5A patent/HK1213273A1/zh unknown
- 2014-03-11 CN CN201480025467.XA patent/CN105209487A/zh active Pending
- 2014-03-11 KR KR1020157029441A patent/KR20150132449A/ko not_active Withdrawn
- 2014-03-11 US US14/774,191 patent/US20160030524A1/en not_active Abandoned
- 2014-03-11 CA CA2905739A patent/CA2905739A1/en not_active Abandoned
- 2014-03-11 RU RU2015144076A patent/RU2015144076A/ru not_active Application Discontinuation
- 2014-03-11 SG SG11201507618YA patent/SG11201507618YA/en unknown
- 2014-03-11 JP JP2016501214A patent/JP2016518321A/ja active Pending
- 2014-03-11 WO PCT/US2014/023357 patent/WO2014150477A1/en not_active Ceased
- 2014-03-11 AU AU2014237111A patent/AU2014237111B2/en not_active Ceased
- 2014-03-11 PE PE2015002012A patent/PE20160121A1/es not_active Application Discontinuation
- 2014-03-11 EP EP14770228.6A patent/EP2970430A4/en not_active Withdrawn
- 2014-03-11 BR BR112015022730A patent/BR112015022730A2/pt not_active IP Right Cessation
- 2014-03-13 UY UY0001035412A patent/UY35412A/es not_active Application Discontinuation
- 2014-03-13 TW TW103109012A patent/TW201521761A/zh unknown
-
2015
- 2015-10-14 ZA ZA2015/07684A patent/ZA201507684B/en unknown
Also Published As
| Publication number | Publication date |
|---|---|
| BR112015022730A2 (pt) | 2017-10-31 |
| AU2014237111B2 (en) | 2018-06-21 |
| PE20160121A1 (es) | 2016-03-03 |
| EP2970430A4 (en) | 2017-01-11 |
| US20160030524A1 (en) | 2016-02-04 |
| AU2014237111A1 (en) | 2015-10-08 |
| EP2970430A1 (en) | 2016-01-20 |
| SG10201803999UA (en) | 2018-06-28 |
| CN105209487A (zh) | 2015-12-30 |
| MX2015012905A (es) | 2016-06-16 |
| HK1213273A1 (zh) | 2016-06-30 |
| ZA201507684B (en) | 2017-06-28 |
| JP2016518321A (ja) | 2016-06-23 |
| CA2905739A1 (en) | 2014-09-25 |
| SG11201507618YA (en) | 2015-10-29 |
| UY35412A (es) | 2014-10-31 |
| WO2014150477A1 (en) | 2014-09-25 |
| TW201521761A (zh) | 2015-06-16 |
| KR20150132449A (ko) | 2015-11-25 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FA92 | Acknowledgement of application withdrawn (lack of supplementary materials submitted) |
Effective date: 20190205 |