EA038573B1 - Лиофилизированный состав, содержащий фактор ix, для предупреждения приступов кровотечения - Google Patents

Лиофилизированный состав, содержащий фактор ix, для предупреждения приступов кровотечения Download PDF

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Publication number
EA038573B1
EA038573B1 EA201691807A EA201691807A EA038573B1 EA 038573 B1 EA038573 B1 EA 038573B1 EA 201691807 A EA201691807 A EA 201691807A EA 201691807 A EA201691807 A EA 201691807A EA 038573 B1 EA038573 B1 EA 038573B1
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EA
Eurasian Patent Office
Prior art keywords
lyophilization
fix
concentration
polypeptide
vial
Prior art date
Application number
EA201691807A
Other languages
English (en)
Russian (ru)
Other versions
EA201691807A1 (ru
Inventor
Брайан М. Тоум
Чери Паркхурст-Ланг
Брэндон В. Левейлл
Original Assignee
Биовератив Терапьютикс Инк.
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=54196282&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=EA038573(B1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Биовератив Терапьютикс Инк. filed Critical Биовератив Терапьютикс Инк.
Publication of EA201691807A1 publication Critical patent/EA201691807A1/ru
Publication of EA038573B1 publication Critical patent/EA038573B1/ru

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46Hydrolases (3)
    • A61K38/48Hydrolases (3) acting on peptide bonds (3.4)
    • A61K38/482Serine endopeptidases (3.4.21)
    • A61K38/4846Factor 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)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12YENZYMES
    • C12Y304/00Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
    • C12Y304/21Serine endopeptidases (3.4.21)
    • C12Y304/21022Coagulation factor IXa (3.4.21.22)
    • FMECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F26DRYING
    • F26BDRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
    • F26B5/00Drying solid materials or objects by processes not involving the application of heat
    • F26B5/04Drying 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
    • F26B5/06Drying 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)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • General Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Mechanical Engineering (AREA)
  • Immunology (AREA)
  • Genetics & Genomics (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • Dermatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Monitoring And Testing Of Transmission In General (AREA)
  • Mobile Radio Communication Systems (AREA)
EA201691807A 2014-03-24 2015-03-24 Лиофилизированный состав, содержащий фактор ix, для предупреждения приступов кровотечения EA038573B1 (ru)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201461969801P 2014-03-24 2014-03-24
PCT/US2015/022141 WO2015148444A1 (en) 2014-03-24 2015-03-24 Lyophilized factor ix formulations

Publications (2)

Publication Number Publication Date
EA201691807A1 EA201691807A1 (ru) 2017-03-31
EA038573B1 true EA038573B1 (ru) 2021-09-16

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 After (1)

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EA202092926A EA202092926A3 (ru) 2014-03-24 2015-03-24 Лиофилизированные составы, содержащие фактор ix

Country Status (16)

Country Link
US (3) US10772942B2 (enExample)
EP (1) EP3123090A4 (enExample)
JP (4) JP7058940B2 (enExample)
KR (1) KR102385372B1 (enExample)
AR (1) AR099838A1 (enExample)
AU (3) AU2015236340B2 (enExample)
CA (1) CA2943034C (enExample)
CL (1) CL2016002386A1 (enExample)
EA (2) EA038573B1 (enExample)
IL (3) IL247869B (enExample)
MA (1) MA39779A (enExample)
MX (2) MX387269B (enExample)
PH (1) PH12016501877A1 (enExample)
SG (3) SG11201607642RA (enExample)
TW (1) TWI700101B (enExample)
WO (1) WO2015148444A1 (enExample)

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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
US10772942B2 (en) 2014-03-24 2020-09-15 Bioverativ Therapeutics Inc. Lyophilized factor IX formulations
IL319473A (en) * 2016-12-02 2025-05-01 Bioverativ Therapeutics Inc Methods for treating hemophilic arthritis using chimeric blood clotting factors
BR112020000592A2 (pt) * 2017-07-11 2020-07-14 Universal Stabilization Technologies, Inc. método para conservar materiais biológicos
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
WO2021158759A2 (en) 2020-02-04 2021-08-12 Regeneron Pharmaceuticals, Inc. Target residual moisture content for lyophilized drug product
BR112022022869A2 (pt) * 2020-05-11 2023-01-31 Alkermes Pharma Ireland Ltd Composições de polipeptídeo de fusão de il-2 e métodos de fabricação e uso destas
CN118557531B (zh) * 2024-08-02 2024-10-18 成都蓉生药业有限责任公司 一种重组人凝血因子VIII-Fc融合蛋白冻干制剂的制备方法

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Publication number Priority date Publication date Assignee Title
US5733873A (en) * 1992-10-02 1998-03-31 Pharmacia & Upjohn Ab Composition comprising coagulation factor VIII formulation, process for its preparation and use of a surfactant as stabilizer
EP1219298A1 (en) * 1999-09-17 2002-07-03 Takeda Chemical Industries, Ltd. Process for producing protein powder
WO2006029467A1 (en) * 2004-09-16 2006-03-23 Btf Pty Ltd Rapid freeze drying process
US20120116054A1 (en) * 2005-07-22 2012-05-10 Sampathkumar Krishnan Concentrated protein lyophilates, methods, and uses
US20070135343A1 (en) * 2005-11-01 2007-06-14 Wyeth Sodium chloride solution for drug reconstitution or dilution
US20080060379A1 (en) * 2006-09-08 2008-03-13 Alan Cheng Cryogenic refrigeration system for lyophilization
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Also Published As

Publication number Publication date
IL272257A (en) 2020-02-27
NZ724351A (en) 2023-10-27
JP7503583B2 (ja) 2024-06-20
US20210069307A1 (en) 2021-03-11
JP7058940B2 (ja) 2022-04-25
WO2015148444A1 (en) 2015-10-01
MX2016012447A (es) 2017-01-06
IL272257B (en) 2021-03-25
TW201605492A (zh) 2016-02-16
CL2016002386A1 (es) 2017-06-23
SG10201808249VA (en) 2018-10-30
AU2020202863A1 (en) 2020-05-21
MX2021012939A (es) 2021-11-25
JP7759978B2 (ja) 2025-10-24
EP3123090A1 (en) 2017-02-01
US20170173122A1 (en) 2017-06-22
AR099838A1 (es) 2016-08-24
CA2943034C (en) 2022-06-14
IL247869B (en) 2020-02-27
JP2020063313A (ja) 2020-04-23
US10772942B2 (en) 2020-09-15
AU2022215218A1 (en) 2022-09-01
EA202092926A3 (ru) 2021-10-29
KR102385372B1 (ko) 2022-04-11
AU2022215218B2 (en) 2025-12-18
US12128092B2 (en) 2024-10-29
EP3123090A4 (en) 2017-12-13
AU2020202863B2 (en) 2022-09-01
SG10201913735SA (en) 2020-03-30
JP2022044689A (ja) 2022-03-17
JP2024053015A (ja) 2024-04-12
JP2017510585A (ja) 2017-04-13
MX387269B (es) 2025-03-18
PH12016501877A1 (en) 2016-12-19
KR20160137577A (ko) 2016-11-30
CA2943034A1 (en) 2015-10-01
EA201691807A1 (ru) 2017-03-31
IL281197A (en) 2021-04-29
MA39779A (fr) 2017-02-01
EA202092926A2 (ru) 2021-07-30
BR112016021777A2 (pt) 2017-10-03
IL247869A0 (en) 2016-11-30
IL281197B (en) 2022-06-01
TWI700101B (zh) 2020-08-01
AU2015236340B2 (en) 2020-02-06
SG11201607642RA (en) 2016-10-28
US20250121042A1 (en) 2025-04-17
AU2015236340A1 (en) 2016-09-29

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