CA2943034C - Lyophilized factor ix formulations - Google Patents

Lyophilized factor ix formulations Download PDF

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Publication number
CA2943034C
CA2943034C CA2943034A CA2943034A CA2943034C CA 2943034 C CA2943034 C CA 2943034C CA 2943034 A CA2943034 A CA 2943034A CA 2943034 A CA2943034 A CA 2943034A CA 2943034 C CA2943034 C CA 2943034C
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CA
Canada
Prior art keywords
lyophilization
vial
formulation
fix
concentration
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
CA2943034A
Other languages
English (en)
French (fr)
Other versions
CA2943034A1 (en
Inventor
Brian M. THOME
Cherie Parkhurst-Lang
Brandon W. LEVEILLE
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Bioverativ Therapeutics Inc
Original Assignee
Bioverativ Therapeutics Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
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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=CA2943034(C) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Bioverativ Therapeutics Inc filed Critical Bioverativ Therapeutics Inc
Publication of CA2943034A1 publication Critical patent/CA2943034A1/en
Application granted granted Critical
Publication of CA2943034C publication Critical patent/CA2943034C/en
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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)
CA2943034A 2014-03-24 2015-03-24 Lyophilized factor ix formulations Active CA2943034C (en)

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
CA2943034A1 CA2943034A1 (en) 2015-10-01
CA2943034C true CA2943034C (en) 2022-06-14

Family

ID=54196282

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2943034A Active CA2943034C (en) 2014-03-24 2015-03-24 Lyophilized factor ix formulations

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)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
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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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Also Published As

Publication number Publication date
IL272257A (en) 2020-02-27
EA038573B1 (ru) 2021-09-16
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
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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