EA202092926A3 - Лиофилизированные составы, содержащие фактор ix - Google Patents
Лиофилизированные составы, содержащие фактор ixInfo
- Publication number
- EA202092926A3 EA202092926A3 EA202092926A EA202092926A EA202092926A3 EA 202092926 A3 EA202092926 A3 EA 202092926A3 EA 202092926 A EA202092926 A EA 202092926A EA 202092926 A EA202092926 A EA 202092926A EA 202092926 A3 EA202092926 A3 EA 202092926A3
- Authority
- EA
- Eurasian Patent Office
- Prior art keywords
- compositions containing
- lyophilized compositions
- containing factor
- factor
- lyophilized
- Prior art date
Links
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
- A61K9/14—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
- 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
- A61K38/43—Enzymes; Proenzymes; Derivatives thereof
- A61K38/46—Hydrolases (3)
- A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
- A61K38/482—Serine endopeptidases (3.4.21)
- A61K38/4846—Factor VII (3.4.21.21); Factor IX (3.4.21.22); Factor Xa (3.4.21.6); Factor XI (3.4.21.27); Factor XII (3.4.21.38)
-
- 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
- A61K47/22—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
- 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
- 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)
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F26—DRYING
- F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
- F26B5/00—Drying solid materials or objects by processes not involving the application of heat
- F26B5/04—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum
- F26B5/06—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum the process involving freezing
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Organic Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Engineering & Computer Science (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Mechanical Engineering (AREA)
- Wood Science & Technology (AREA)
- Zoology (AREA)
- Genetics & Genomics (AREA)
- Gastroenterology & Hepatology (AREA)
- Immunology (AREA)
- Dermatology (AREA)
- Diabetes (AREA)
- Hematology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Peptides Or Proteins (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201461969801P | 2014-03-24 | 2014-03-24 |
Publications (2)
Publication Number | Publication Date |
---|---|
EA202092926A2 EA202092926A2 (ru) | 2021-07-30 |
EA202092926A3 true EA202092926A3 (ru) | 2021-10-29 |
Family
ID=54196282
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EA201691807A EA038573B1 (ru) | 2014-03-24 | 2015-03-24 | Лиофилизированный состав, содержащий фактор ix, для предупреждения приступов кровотечения |
EA202092926A EA202092926A3 (ru) | 2014-03-24 | 2015-03-24 | Лиофилизированные составы, содержащие фактор ix |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EA201691807A EA038573B1 (ru) | 2014-03-24 | 2015-03-24 | Лиофилизированный состав, содержащий фактор ix, для предупреждения приступов кровотечения |
Country Status (17)
Country | Link |
---|---|
US (2) | US10772942B2 (ru) |
EP (1) | EP3123090A4 (ru) |
JP (4) | JP7058940B2 (ru) |
KR (1) | KR102385372B1 (ru) |
AR (1) | AR099838A1 (ru) |
AU (3) | AU2015236340B2 (ru) |
BR (1) | BR112016021777A2 (ru) |
CA (1) | CA2943034C (ru) |
CL (1) | CL2016002386A1 (ru) |
EA (2) | EA038573B1 (ru) |
IL (3) | IL247869B (ru) |
MA (1) | MA39779A (ru) |
MX (2) | MX2016012447A (ru) |
PH (1) | PH12016501877A1 (ru) |
SG (3) | SG11201607642RA (ru) |
TW (1) | TWI700101B (ru) |
WO (1) | WO2015148444A1 (ru) |
Families Citing this family (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP2968498A4 (en) * | 2013-03-15 | 2016-09-07 | Biogen Ma Inc | PREPARATIONS CONTAINING FACTOR IX POLYPEPTIDE |
KR102385372B1 (ko) * | 2014-03-24 | 2022-04-11 | 바이오버라티브 테라퓨틱스 인크. | 동결건조된 ix 인자 제형 |
US11400051B2 (en) * | 2017-07-11 | 2022-08-02 | Universal Stabilization Technologies, Inc. | Method for preserving biopharmaceuticals |
CN112175088B (zh) * | 2019-07-02 | 2023-03-28 | 江苏晟斯生物制药有限公司 | 改进的fix融合蛋白、缀合物及其应用 |
US20210395325A1 (en) * | 2020-05-11 | 2021-12-23 | Alkermes Pharma Ireland Limited | Il-2 fusion polypeptide compositions and methods of making and using the same |
Family Cites Families (51)
Publication number | Priority date | Publication date | Assignee | Title |
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EP0154316B1 (en) | 1984-03-06 | 1989-09-13 | Takeda Chemical Industries, Ltd. | Chemically modified lymphokine and production thereof |
ATE135370T1 (de) | 1988-12-22 | 1996-03-15 | Kirin Amgen Inc | Chemisch modifizierte granulocytenkolonie erregender faktor |
DK0461200T3 (da) | 1989-02-21 | 1997-03-10 | Univ Washington | Modificerede former af reproduktionshormoner |
US6552170B1 (en) | 1990-04-06 | 2003-04-22 | Amgen Inc. | PEGylation reagents and compounds formed therewith |
EP0575545B1 (en) | 1991-03-15 | 2003-05-21 | Amgen Inc. | Pegylation of polypeptides |
FR2686899B1 (fr) | 1992-01-31 | 1995-09-01 | Rhone Poulenc Rorer Sa | Nouveaux polypeptides biologiquement actifs, leur preparation et compositions pharmaceutiques les contenant. |
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 |
DE4405426A1 (de) | 1994-02-21 | 1995-08-24 | Boehringer Mannheim Gmbh | Pharmazeutisches Präparat enthaltend Plasminogenaktivator (t-PA) oder dessen Derivate |
US6372716B1 (en) | 1994-04-26 | 2002-04-16 | Genetics Institute, Inc. | Formulations for factor IX |
US6685940B2 (en) | 1995-07-27 | 2004-02-03 | Genentech, Inc. | Protein formulation |
US5770700A (en) * | 1996-01-25 | 1998-06-23 | Genetics Institute, Inc. | Liquid factor IX formulations |
IN184589B (ru) * | 1996-10-16 | 2000-09-09 | Alza Corp | |
EP1219298A4 (en) * | 1999-09-17 | 2003-06-11 | Takeda Chemical Industries Ltd | PROCESS FOR PRODUCING PROTEIN POWDER |
JP2001151694A (ja) | 1999-09-17 | 2001-06-05 | Takeda Chem Ind Ltd | タンパク質粉体の製造法 |
JP5179689B2 (ja) | 2000-02-11 | 2013-04-10 | メルク パテント ゲゼルシャフト ミット ベシュレンクテル ハフツング | 抗体ベース融合タンパク質の循環系内半減期の増強 |
US7125841B2 (en) | 2000-11-14 | 2006-10-24 | The University Of Texas Systems | Mutant human factor IX with an increased resistance to inhibition by heparin |
CA2457429A1 (en) | 2001-09-04 | 2003-03-13 | Francis J. Carr | Modified factor ix |
EP2261250B1 (en) | 2001-12-21 | 2015-07-01 | Human Genome Sciences, Inc. | GCSF-Albumin fusion proteins |
US7348004B2 (en) | 2003-05-06 | 2008-03-25 | Syntonix Pharmaceuticals, Inc. | Immunoglobulin chimeric monomer-dimer hybrids |
ES2558102T3 (es) | 2003-05-06 | 2016-02-02 | Biogen Hemophilia Inc. | Proteínas quiméricas del factor de coagulación para el tratamiento de un trastorno hemostático |
JP2005060378A (ja) | 2003-07-28 | 2005-03-10 | Yamanouchi Pharmaceut Co Ltd | 生理活性蛋白質含有凍結乾燥製剤 |
US20050152979A1 (en) | 2003-09-05 | 2005-07-14 | Cell Therapeutics, Inc. | Hydrophobic drug compositions containing reconstitution enhancer |
AU2005225000A1 (en) | 2004-03-04 | 2005-09-29 | Wyeth | Lyophilization method to improve excipient crystallization |
WO2006029467A1 (en) * | 2004-09-16 | 2006-03-23 | Btf Pty Ltd | Rapid freeze drying process |
LT3130601T (lt) | 2004-11-12 | 2020-09-10 | Bayer Healthcare Llc | Į vietą nukreipta fviii modifikacija |
US8367805B2 (en) | 2004-11-12 | 2013-02-05 | Xencor, Inc. | Fc variants with altered binding to FcRn |
WO2007014073A2 (en) * | 2005-07-22 | 2007-02-01 | Amgen Inc. | Concentrated protein lyophilates, methods, and uses |
CA2625998C (en) * | 2005-10-06 | 2015-12-01 | Xencor, Inc. | Optimized anti-cd30 antibodies |
KR20110128957A (ko) * | 2005-11-01 | 2011-11-30 | 와이어쓰 엘엘씨 | 약물 재구성 또는 희석을 위한 염화나트륨 용액 |
US8048848B2 (en) | 2006-02-03 | 2011-11-01 | Prolor Biotech Ltd. | Long-acting interferons and derivatives thereof and methods thereof |
MX2008012748A (es) | 2006-04-04 | 2009-01-07 | Shire Pharmaceuticals Ireland | Un proceso para la concentracion de un polipeptido. |
US8383388B2 (en) | 2006-06-19 | 2013-02-26 | Catalyst Biosciences, Inc. | Modified coagulation factor IX polypeptides and use thereof for treatment |
US8015841B2 (en) * | 2006-09-08 | 2011-09-13 | Praxair Technology, Inc. | Cryogenic refrigeration system for lyophilization |
US7700734B2 (en) | 2007-01-09 | 2010-04-20 | Shu-Wha Lin | Recombinant human factor IX and use thereof |
EA021222B8 (ru) | 2007-06-21 | 2015-11-30 | ИксЭль-ПРОТЕИН ГМБХ | Биологически активные белки, имеющие повышенную стабильность in vivo и/или in vitro |
CN104004739A (zh) | 2007-10-15 | 2014-08-27 | 北卡罗来纳-查佩尔山大学 | 半衰期延长的人因子ix变体 |
AU2008342260B2 (en) | 2007-12-27 | 2013-10-17 | Baxter Healthcare S.A. | Chemically modified Factor IX |
RU2010146387A (ru) | 2008-04-16 | 2012-05-27 | БАЙЕР ХЕЛСКЕР ЛЛСи (US) | Модифицированные полипептиды фактора ix и их применение |
JP2011517950A (ja) | 2008-04-16 | 2011-06-23 | バイエル・ヘルスケア・エルエルシー | 第ix因子の部位特異的修飾 |
EP2444491B1 (en) | 2008-04-21 | 2016-11-16 | Novo Nordisk Healthcare Ag | Hyperglycosylated human coagulation factor IX |
US9884019B2 (en) | 2008-08-05 | 2018-02-06 | Wyeth Llc | Lyophilization above collapse |
GB2479069B (en) | 2008-09-24 | 2012-07-25 | Stabilitech Ltd | Method for preserving polypeptides using a sugar and polyethyleneimine |
JP2012530721A (ja) | 2009-06-18 | 2012-12-06 | ワイス・エルエルシー | 小モジュール免疫薬のための凍結乾燥製剤 |
US20120121580A1 (en) * | 2009-07-28 | 2012-05-17 | Merck Sharp & Dohme Corp. | Methods for producing high concentration lyophilized pharmaceutical formulations |
KR20230156435A (ko) | 2010-07-09 | 2023-11-14 | 바이오버라티브 테라퓨틱스 인크. | 인자 ix 폴리펩티드 및 이들의 사용 방법 |
SG188662A1 (en) | 2010-09-30 | 2013-05-31 | Toyama Chemical Co Ltd | Meglumine salt of 6-fluoro-3-hydroxy-2-pyrazine carboxamide |
CA2827033A1 (en) | 2011-02-09 | 2012-08-16 | Glaxosmithkline Llc | Lyophilized formulations |
AU2013270682A1 (en) * | 2012-06-08 | 2014-12-11 | Biogen Ma Inc. | Procoagulant compounds |
WO2014052490A1 (en) * | 2012-09-25 | 2014-04-03 | Biogen Idec Ma Inc. | Methods of using fix polypeptides |
EP2968498A4 (en) * | 2013-03-15 | 2016-09-07 | Biogen Ma Inc | PREPARATIONS CONTAINING FACTOR IX POLYPEPTIDE |
KR102385372B1 (ko) * | 2014-03-24 | 2022-04-11 | 바이오버라티브 테라퓨틱스 인크. | 동결건조된 ix 인자 제형 |
-
2015
- 2015-03-24 KR KR1020167028692A patent/KR102385372B1/ko active IP Right Grant
- 2015-03-24 US US15/128,951 patent/US10772942B2/en active Active
- 2015-03-24 SG SG11201607642RA patent/SG11201607642RA/en unknown
- 2015-03-24 EA EA201691807A patent/EA038573B1/ru unknown
- 2015-03-24 MX MX2016012447A patent/MX2016012447A/es unknown
- 2015-03-24 WO PCT/US2015/022141 patent/WO2015148444A1/en active Application Filing
- 2015-03-24 MA MA039779A patent/MA39779A/fr unknown
- 2015-03-24 CA CA2943034A patent/CA2943034C/en active Active
- 2015-03-24 BR BR112016021777A patent/BR112016021777A2/pt active Search and Examination
- 2015-03-24 AU AU2015236340A patent/AU2015236340B2/en not_active Withdrawn - After Issue
- 2015-03-24 EA EA202092926A patent/EA202092926A3/ru unknown
- 2015-03-24 SG SG10201913735SA patent/SG10201913735SA/en unknown
- 2015-03-24 EP EP15769411.8A patent/EP3123090A4/en active Pending
- 2015-03-24 SG SG10201808249VA patent/SG10201808249VA/en unknown
- 2015-03-24 TW TW104109389A patent/TWI700101B/zh active
- 2015-03-24 JP JP2016558751A patent/JP7058940B2/ja active Active
- 2015-03-25 AR ARP150100880A patent/AR099838A1/es unknown
-
2016
- 2016-09-18 IL IL247869A patent/IL247869B/en active IP Right Grant
- 2016-09-22 CL CL2016002386A patent/CL2016002386A1/es unknown
- 2016-09-23 MX MX2021012939A patent/MX2021012939A/es unknown
- 2016-09-23 PH PH12016501877A patent/PH12016501877A1/en unknown
-
2020
- 2020-01-26 IL IL272257A patent/IL272257B/en active IP Right Grant
- 2020-02-03 JP JP2020016131A patent/JP2020063313A/ja active Pending
- 2020-04-30 AU AU2020202863A patent/AU2020202863B2/en active Active
- 2020-08-17 US US16/995,173 patent/US20210069307A1/en active Pending
-
2021
- 2021-03-02 IL IL281197A patent/IL281197B/en unknown
-
2022
- 2022-01-20 JP JP2022007013A patent/JP2022044689A/ja active Pending
- 2022-08-10 AU AU2022215218A patent/AU2022215218A1/en active Pending
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2024
- 2024-03-06 JP JP2024033771A patent/JP2024053015A/ja active Pending
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