MA39779A - Formulations de facteur ix lyophilisées - Google Patents

Formulations de facteur ix lyophilisées

Info

Publication number
MA39779A
MA39779A MA039779A MA39779A MA39779A MA 39779 A MA39779 A MA 39779A MA 039779 A MA039779 A MA 039779A MA 39779 A MA39779 A MA 39779A MA 39779 A MA39779 A MA 39779A
Authority
MA
Morocco
Prior art keywords
fix
polypeptide
formulations
present
factor
Prior art date
Application number
MA039779A
Other languages
English (en)
Inventor
Brandon W Leveille
Cherie Parkhurst-Lang
Brian M Thome
Original Assignee
Biogen Ma 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
Family has litigation
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=MA39779(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Biogen Ma Inc filed Critical Biogen Ma Inc
Publication of MA39779A publication Critical patent/MA39779A/fr

Links

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
    • A61K38/43—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
    • 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
    • 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)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (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)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Genetics & Genomics (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)

Abstract

La présente invention concerne, entre autres, des formulations de pré-lyophilisation, des formulations reconstituées, et des compositions de poudre de lyophilat comprenant un polypeptide du facteur ix (fix). La présente invention concerne également des procédés de lyophilisation pour la production de poudre de lyophilat comprenant un polypeptide fix. La présente invention concerne une formulation de pré-lyophilisation comprenant : (a) un polypeptide du facteur ix (fix) ayant une activité de coagulation fix ; (b) un agent tampon ; (c) un agent stabilisant ; (d) un agent gonflant ; et (e) un tensioactif, la formulation ayant un volume de remplissage inférieur à environ 5 ml, et chacun de (a) - (e) étant au niveau d'une quantité par flacon (mg/flacon) suffisante pour permettre (1) une meilleure stabilité du polypeptide fix lorsqu'elle est lyophilisée.
MA039779A 2014-03-24 2015-03-24 Formulations de facteur ix lyophilisées MA39779A (fr)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US201461969801P 2014-03-24 2014-03-24

Publications (1)

Publication Number Publication Date
MA39779A true MA39779A (fr) 2017-02-01

Family

ID=54196282

Family Applications (1)

Application Number Title Priority Date Filing Date
MA039779A MA39779A (fr) 2014-03-24 2015-03-24 Formulations de facteur ix lyophilisées

Country Status (16)

Country Link
US (3) US10772942B2 (fr)
EP (1) EP3123090A4 (fr)
JP (4) JP7058940B2 (fr)
KR (1) KR102385372B1 (fr)
AR (1) AR099838A1 (fr)
AU (3) AU2015236340B2 (fr)
CA (1) CA2943034C (fr)
CL (1) CL2016002386A1 (fr)
EA (2) EA038573B1 (fr)
IL (3) IL247869B (fr)
MA (1) MA39779A (fr)
MX (2) MX387269B (fr)
PH (1) PH12016501877A1 (fr)
SG (3) SG10201808249VA (fr)
TW (1) TWI700101B (fr)
WO (1) WO2015148444A1 (fr)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EA037906B1 (ru) * 2013-03-15 2021-06-04 Биовератив Терапьютикс Инк. Препараты полипептида фактора ix
EP3123090A4 (fr) 2014-03-24 2017-12-13 Bioverativ Therapeutics Inc. Formulations de facteur ix lyophilisées
WO2018102743A1 (fr) * 2016-12-02 2018-06-07 Bioverativ Therapeutics Inc. Méthodes de traitement de l'arthropathie hémophilique à l'aide de facteurs de coagulation chimériques
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
AU2021217370A1 (en) * 2020-02-04 2022-08-18 Regeneron Pharmaceuticals, Inc. Target residual moisture content for lyophilized drug product
EP4149514A4 (fr) * 2020-05-11 2024-06-26 Alkermes Pharma Ireland Limited Compositions de polypeptides de fusion d'il-2 et leurs procédés de fabrication et d'utilisation
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
WO2015148444A1 (fr) 2015-10-01
IL247869B (en) 2020-02-27
EP3123090A1 (fr) 2017-02-01
IL272257B (en) 2021-03-25
JP7058940B2 (ja) 2022-04-25
JP2024053015A (ja) 2024-04-12
AU2020202863B2 (en) 2022-09-01
MX2016012447A (es) 2017-01-06
TW201605492A (zh) 2016-02-16
JP2022044689A (ja) 2022-03-17
AU2022215218B2 (en) 2025-12-18
EA202092926A2 (ru) 2021-07-30
JP2020063313A (ja) 2020-04-23
AU2015236340A1 (en) 2016-09-29
JP2017510585A (ja) 2017-04-13
EA201691807A1 (ru) 2017-03-31
TWI700101B (zh) 2020-08-01
SG10201913735SA (en) 2020-03-30
US20210069307A1 (en) 2021-03-11
US20250121042A1 (en) 2025-04-17
IL281197A (en) 2021-04-29
MX2021012939A (es) 2021-11-25
MX387269B (es) 2025-03-18
PH12016501877A1 (en) 2016-12-19
US10772942B2 (en) 2020-09-15
AU2022215218A1 (en) 2022-09-01
IL281197B (en) 2022-06-01
EA202092926A3 (ru) 2021-10-29
AU2020202863A1 (en) 2020-05-21
CA2943034C (fr) 2022-06-14
EP3123090A4 (fr) 2017-12-13
JP7759978B2 (ja) 2025-10-24
NZ724351A (en) 2023-10-27
KR102385372B1 (ko) 2022-04-11
IL272257A (en) 2020-02-27
BR112016021777A2 (pt) 2017-10-03
EA038573B1 (ru) 2021-09-16
JP7503583B2 (ja) 2024-06-20
US12128092B2 (en) 2024-10-29
AR099838A1 (es) 2016-08-24
US20170173122A1 (en) 2017-06-22
KR20160137577A (ko) 2016-11-30
AU2015236340B2 (en) 2020-02-06
CL2016002386A1 (es) 2017-06-23
SG11201607642RA (en) 2016-10-28
SG10201808249VA (en) 2018-10-30
IL247869A0 (en) 2016-11-30
CA2943034A1 (fr) 2015-10-01

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