PL3177317T3 - Formulacja czynnika viii - Google Patents
Formulacja czynnika viiiInfo
- Publication number
- PL3177317T3 PL3177317T3 PL15741220T PL15741220T PL3177317T3 PL 3177317 T3 PL3177317 T3 PL 3177317T3 PL 15741220 T PL15741220 T PL 15741220T PL 15741220 T PL15741220 T PL 15741220T PL 3177317 T3 PL3177317 T3 PL 3177317T3
- Authority
- PL
- Poland
- Prior art keywords
- factor viii
- viii formulation
- formulation
- factor
- viii
- Prior art date
Links
- 229960000301 factor viii Drugs 0.000 title 1
- 238000009472 formulation Methods 0.000 title 1
- 239000000203 mixture Substances 0.000 title 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
- A61K47/16—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
-
- 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
- A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
-
- 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
- A61K47/06—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
- 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
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
-
- 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
- A61K9/19—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
-
- 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)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Hematology (AREA)
- Gastroenterology & Hepatology (AREA)
- Zoology (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Immunology (AREA)
- Organic Chemistry (AREA)
- Inorganic Chemistry (AREA)
- Dermatology (AREA)
- Diabetes (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Toxicology (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Peptides Or Proteins (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP14179732 | 2014-08-04 | ||
| EP15741220.6A EP3177317B1 (en) | 2014-08-04 | 2015-07-24 | Factor viii formulation |
| PCT/EP2015/066999 WO2016020210A1 (en) | 2014-08-04 | 2015-07-24 | Csl behring gmbh |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| PL3177317T3 true PL3177317T3 (pl) | 2020-07-27 |
Family
ID=51298563
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PL15741220T PL3177317T3 (pl) | 2014-08-04 | 2015-07-24 | Formulacja czynnika viii |
Country Status (17)
| Country | Link |
|---|---|
| US (1) | US10238718B2 (pl) |
| EP (1) | EP3177317B1 (pl) |
| JP (1) | JP6516829B2 (pl) |
| KR (1) | KR102192494B1 (pl) |
| CN (1) | CN106687126B (pl) |
| AU (1) | AU2015299224B2 (pl) |
| BR (1) | BR112017002090B1 (pl) |
| CA (1) | CA2956412A1 (pl) |
| DK (1) | DK3177317T3 (pl) |
| ES (1) | ES2788870T3 (pl) |
| IL (1) | IL250343B (pl) |
| MX (1) | MX2017000862A (pl) |
| NZ (1) | NZ729629A (pl) |
| PL (1) | PL3177317T3 (pl) |
| RU (1) | RU2689338C2 (pl) |
| SG (2) | SG11201700550YA (pl) |
| WO (1) | WO2016020210A1 (pl) |
Families Citing this family (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| US11142553B2 (en) | 2016-11-29 | 2021-10-12 | Spiber Inc. | Protein composition, method for producing same and method for improving heat stability |
| WO2018132874A1 (en) * | 2017-01-19 | 2018-07-26 | Csl Limited | Method of preventing an immune response with alpha- 1 anti-trypsin |
| JP7370974B2 (ja) * | 2017-11-07 | 2023-10-30 | ラニ セラピューティクス， エルエルシー | 嚥下可能薬物送達デバイスを使用する腸管組織への送達のための凝固因子調製物 |
| CN113105562B (zh) * | 2018-09-26 | 2023-12-01 | 安源医药科技（上海）有限公司 | 突变型单链人凝血因子viii在制备融合蛋白中的应用 |
| CN112138149A (zh) * | 2019-06-28 | 2020-12-29 | 北京基科晟斯医药科技有限公司 | 重组凝血因子viii制剂 |
| US20220380439A1 (en) | 2020-11-09 | 2022-12-01 | Takeda Pharmaceutical Company Limited | Purification of fviii from plasma using silicon oxide adsorption |
Family Cites Families (45)
| 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 |
| DK0410207T3 (da) | 1989-07-24 | 1997-07-14 | Bayer Ag | Stabilisering af højrensede proteiner. |
| 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 |
| DE69333928T2 (de) | 1992-04-30 | 2006-08-17 | Probitas Pharma Inc., Los Angeles | Verbesserte solubilisierung und stabilisierung des faktor viii-komplexes |
| 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 |
| GB9501040D0 (en) | 1995-01-19 | 1995-03-08 | Quadrant Holdings Cambridge | Dried composition |
| SE9501189D0 (sv) | 1995-03-31 | 1995-03-31 | Pharmacia Ab | Protein formulation |
| US5763401A (en) * | 1996-07-12 | 1998-06-09 | Bayer Corporation | Stabilized albumin-free recombinant factor VIII preparation having a low sugar content |
| DK2130554T3 (da) * | 1999-02-22 | 2012-12-03 | Univ Connecticut | Albuminfrie faktor VIII-præparater |
| CN101724075B (zh) | 2001-10-10 | 2014-04-30 | 诺和诺德公司 | 肽的重构和糖缀合 |
| GB0207092D0 (en) | 2002-03-26 | 2002-05-08 | Sod Conseils Rech Applic | Stable pharmaceutical composition containing factor VIII |
| US7041635B2 (en) | 2003-01-28 | 2006-05-09 | In2Gen Co., Ltd. | Factor VIII polypeptide |
| EP2298287B1 (en) | 2003-12-19 | 2018-04-11 | Novo Nordisk Health Care AG | Stabilised compositions of factor VII polypeptides |
| KR100624013B1 (ko) * | 2004-06-25 | 2006-09-19 | 주식회사 녹십자홀딩스 | 동결건조된 알부민 비함유 재조합 사람 혈액응고 제 8인자 제제 |
| US7523304B2 (en) * | 2005-11-22 | 2009-04-21 | Ntt Docomo, Inc. | Generation of set coverings with free riders, and generation of ordered sets of meeting points, in systems which include, but are not limited to, systems for broadcast encryption and systems for certificate revocation |
| PL1986612T3 (pl) | 2006-02-07 | 2013-02-28 | Shire Human Genetic Therapies | Stabilizowana kompozycja glukocerebrozydazy |
| TW200806317A (en) | 2006-03-20 | 2008-02-01 | Wyeth Corp | Methods for reducing protein aggregation |
| US7985839B2 (en) | 2006-03-31 | 2011-07-26 | Baxter International Inc. | Factor VIII polymer conjugates |
| US7982010B2 (en) | 2006-03-31 | 2011-07-19 | Baxter International Inc. | Factor VIII polymer conjugates |
| US7645860B2 (en) | 2006-03-31 | 2010-01-12 | Baxter Healthcare S.A. | Factor VIII polymer conjugates |
| US7683158B2 (en) | 2006-03-31 | 2010-03-23 | Baxter International Inc. | Pegylated factor VIII |
| CA2673459C (en) | 2006-12-22 | 2016-09-13 | Stefan Schulte | Modified coagulation factors with prolonged in vivo half-life |
| NZ577728A (en) | 2006-12-27 | 2012-01-12 | Baxter Int | Von willebrand factor- and factor viii-polymer conjugates having a releasable linkage |
| EP1988101A1 (en) | 2007-05-04 | 2008-11-05 | Novo Nordisk A/S | Improvement of factor VIII polypeptide titers in cell cultures |
| PL2167526T3 (pl) | 2007-07-11 | 2011-09-30 | Novo Nordisk As | Oczyszczanie czynnika VIII za pomocą żywicy o mieszanej funkcji lub wielofunkcyjnej |
| US8173597B2 (en) | 2007-11-09 | 2012-05-08 | Baxter International Inc. | Modified recombinant factor VIII and von Willebrand factor and methods of use |
| CA2715465C (en) | 2008-02-27 | 2017-03-21 | Novo Nordisk A/S | Conjugated factor viii molecules |
| SI2337580T1 (sl) * | 2008-09-03 | 2012-06-29 | Octapharma Ag | Stabilizirani sestavki za rekombinanto proizveden faktor VIII |
| DK2349342T3 (en) | 2008-10-17 | 2018-10-08 | Baxalta GmbH | MODIFIED BLOOD FACTORS INCLUDING A LOW DEGREE OF WATER SOLUBLE POLYMER |
| AU2009313325B2 (en) | 2008-11-07 | 2014-05-01 | Takeda Pharmaceutical Company Limited | Factor VIII formulations |
| ES2401965T3 (es) | 2009-02-19 | 2013-04-25 | Novo Nordisk A/S | Modificación de Factor VIII |
| 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 |
| GB0915480D0 (en) | 2009-09-04 | 2009-10-07 | Arecor Ltd | Stable formulation of factor viii |
| CN102770449B (zh) | 2010-02-16 | 2016-02-24 | 诺沃—诺迪斯克有限公司 | 具有降低的vwf结合的因子viii分子 |
| EP2977055A1 (en) | 2010-02-16 | 2016-01-27 | Novo Nordisk A/S | Factor viii fusion protein |
| ES2541369T3 (es) | 2010-02-16 | 2015-07-17 | Novo Nordisk A/S | Factor VIII recombinante modificado |
| US8859731B2 (en) | 2010-04-21 | 2014-10-14 | Novo Nordisk A/S | Selective modification of proteins |
| US20130183280A1 (en) | 2010-07-15 | 2013-07-18 | Novo Nordisk A/S | Stabilized factor viii variants |
| CN103282042B (zh) | 2010-09-17 | 2014-12-10 | 巴克斯特国际公司 | 通过具有组氨酸的水性制剂在弱酸性至中性pH稳定的免疫球蛋白 |
| CN103917554B (zh) * | 2011-10-18 | 2017-03-08 | 杰特有限公司 | 用于改善重构后纯化的因子viii的稳定性的方法 |
| CN102580062B (zh) * | 2012-03-09 | 2017-03-08 | 中国医学科学院输血研究所 | 人凝血因子VIII与vWF复合物或人凝血因子VIII制剂的干热处理稳定剂 |
| JP2015515482A (ja) * | 2012-04-24 | 2015-05-28 | ノヴォ ノルディスク アー／エス | 血友病の治療に適する化合物 |
| WO2014026954A1 (en) * | 2012-08-13 | 2014-02-20 | Novo Nordisk A/S | Liquid factor viii formulations |
-
2015
- 2015-07-24 MX MX2017000862A patent/MX2017000862A/es unknown
- 2015-07-24 CN CN201580041973.2A patent/CN106687126B/zh active Active
- 2015-07-24 PL PL15741220T patent/PL3177317T3/pl unknown
- 2015-07-24 SG SG11201700550YA patent/SG11201700550YA/en unknown
- 2015-07-24 SG SG10201900598TA patent/SG10201900598TA/en unknown
- 2015-07-24 ES ES15741220T patent/ES2788870T3/es active Active
- 2015-07-24 AU AU2015299224A patent/AU2015299224B2/en active Active
- 2015-07-24 US US15/501,059 patent/US10238718B2/en active Active
- 2015-07-24 RU RU2017106159A patent/RU2689338C2/ru active
- 2015-07-24 NZ NZ729629A patent/NZ729629A/en unknown
- 2015-07-24 DK DK15741220.6T patent/DK3177317T3/da active
- 2015-07-24 JP JP2017506297A patent/JP6516829B2/ja active Active
- 2015-07-24 EP EP15741220.6A patent/EP3177317B1/en active Active
- 2015-07-24 CA CA2956412A patent/CA2956412A1/en active Pending
- 2015-07-24 KR KR1020177006119A patent/KR102192494B1/ko active IP Right Grant
- 2015-07-24 WO PCT/EP2015/066999 patent/WO2016020210A1/en active Application Filing
- 2015-07-24 BR BR112017002090-4A patent/BR112017002090B1/pt active IP Right Grant
-
2017
- 2017-01-30 IL IL250343A patent/IL250343B/en active IP Right Grant
Also Published As
| Publication number | Publication date |
|---|---|
| RU2017106159A3 (pl) | 2018-11-28 |
| CN106687126A (zh) | 2017-05-17 |
| AU2015299224B2 (en) | 2019-06-20 |
| EP3177317B1 (en) | 2020-03-18 |
| NZ729629A (en) | 2021-12-24 |
| EP3177317A1 (en) | 2017-06-14 |
| RU2017106159A (ru) | 2018-09-06 |
| JP6516829B2 (ja) | 2019-05-22 |
| IL250343A0 (en) | 2017-03-30 |
| WO2016020210A1 (en) | 2016-02-11 |
| KR102192494B1 (ko) | 2020-12-18 |
| US20170252412A1 (en) | 2017-09-07 |
| US10238718B2 (en) | 2019-03-26 |
| ES2788870T3 (es) | 2020-10-23 |
| WO2016020210A8 (en) | 2016-04-28 |
| SG10201900598TA (en) | 2019-02-27 |
| AU2015299224A1 (en) | 2017-03-23 |
| DK3177317T3 (en) | 2020-06-15 |
| KR20170040327A (ko) | 2017-04-12 |
| BR112017002090A2 (pt) | 2018-01-30 |
| CA2956412A1 (en) | 2016-02-11 |
| BR112017002090B1 (pt) | 2021-06-01 |
| SG11201700550YA (en) | 2017-02-27 |
| MX2017000862A (es) | 2017-05-01 |
| RU2689338C2 (ru) | 2019-05-27 |
| IL250343B (en) | 2020-10-29 |
| JP2017528440A (ja) | 2017-09-28 |
| CN106687126B (zh) | 2020-07-28 |
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