KR102385372B1 - 동결건조된 ix 인자 제형 - Google Patents

동결건조된 ix 인자 제형 Download PDF

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KR102385372B1
KR102385372B1 KR1020167028692A KR20167028692A KR102385372B1 KR 102385372 B1 KR102385372 B1 KR 102385372B1 KR 1020167028692 A KR1020167028692 A KR 1020167028692A KR 20167028692 A KR20167028692 A KR 20167028692A KR 102385372 B1 KR102385372 B1 KR 102385372B1
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fix
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KR20160137577A (ko
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브라이언 엠 톰
체리 파크허스트-랭
브랜든 더블유 리베일
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바이오버라티브 테라퓨틱스 인크.
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    • 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
    • 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
    • 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

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (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)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Genetics & Genomics (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Dermatology (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (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)
KR1020167028692A 2014-03-24 2015-03-24 동결건조된 ix 인자 제형 Active KR102385372B1 (ko)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201461969801P 2014-03-24 2014-03-24
US61/969,801 2014-03-24
PCT/US2015/022141 WO2015148444A1 (en) 2014-03-24 2015-03-24 Lyophilized factor ix formulations

Publications (2)

Publication Number Publication Date
KR20160137577A KR20160137577A (ko) 2016-11-30
KR102385372B1 true KR102385372B1 (ko) 2022-04-11

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KR1020167028692A Active KR102385372B1 (ko) 2014-03-24 2015-03-24 동결건조된 ix 인자 제형

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US (3) US10772942B2 (enExample)
EP (1) EP3123090A4 (enExample)
JP (4) JP7058940B2 (enExample)
KR (1) KR102385372B1 (enExample)
AR (1) AR099838A1 (enExample)
AU (2) AU2015236340B2 (enExample)
CA (1) CA2943034C (enExample)
CL (1) CL2016002386A1 (enExample)
EA (2) EA202092926A3 (enExample)
IL (3) IL247869B (enExample)
MA (1) MA39779A (enExample)
MX (2) MX387269B (enExample)
PH (1) PH12016501877A1 (enExample)
SG (3) SG10201913735SA (enExample)
TW (1) TWI700101B (enExample)
WO (1) WO2015148444A1 (enExample)

Families Citing this family (8)

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EA037906B1 (ru) * 2013-03-15 2021-06-04 Биовератив Терапьютикс Инк. Препараты полипептида фактора ix
SG10201913735SA (en) 2014-03-24 2020-03-30 Bioverativ Therapeutics Inc Lyophilized factor ix formulations
WO2018102743A1 (en) * 2016-12-02 2018-06-07 Bioverativ Therapeutics Inc. Methods of treating hemophilic arthropathy using chimeric 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
US11525629B2 (en) 2020-02-04 2022-12-13 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 Publication date
IL281197A (en) 2021-04-29
MX387269B (es) 2025-03-18
EA201691807A1 (ru) 2017-03-31
EA202092926A3 (ru) 2021-10-29
IL272257B (en) 2021-03-25
SG10201808249VA (en) 2018-10-30
BR112016021777A2 (pt) 2017-10-03
IL247869A0 (en) 2016-11-30
CL2016002386A1 (es) 2017-06-23
AU2015236340B2 (en) 2020-02-06
US20250121042A1 (en) 2025-04-17
NZ724351A (en) 2023-10-27
JP7759978B2 (ja) 2025-10-24
AU2020202863A1 (en) 2020-05-21
IL281197B (en) 2022-06-01
AR099838A1 (es) 2016-08-24
EP3123090A1 (en) 2017-02-01
TW201605492A (zh) 2016-02-16
AU2015236340A1 (en) 2016-09-29
US20210069307A1 (en) 2021-03-11
US20170173122A1 (en) 2017-06-22
JP2017510585A (ja) 2017-04-13
IL247869B (en) 2020-02-27
MA39779A (fr) 2017-02-01
US12128092B2 (en) 2024-10-29
EA202092926A2 (ru) 2021-07-30
EP3123090A4 (en) 2017-12-13
CA2943034A1 (en) 2015-10-01
WO2015148444A1 (en) 2015-10-01
JP7503583B2 (ja) 2024-06-20
PH12016501877A1 (en) 2016-12-19
SG11201607642RA (en) 2016-10-28
TWI700101B (zh) 2020-08-01
JP2022044689A (ja) 2022-03-17
KR20160137577A (ko) 2016-11-30
AU2020202863B2 (en) 2022-09-01
AU2022215218A1 (en) 2022-09-01
IL272257A (en) 2020-02-27
JP2020063313A (ja) 2020-04-23
US10772942B2 (en) 2020-09-15
JP7058940B2 (ja) 2022-04-25
MX2021012939A (es) 2021-11-25
CA2943034C (en) 2022-06-14
EA038573B1 (ru) 2021-09-16
JP2024053015A (ja) 2024-04-12
SG10201913735SA (en) 2020-03-30
MX2016012447A (es) 2017-01-06

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