CL2016002386A1 - Formulaciones de factor ix liofilizadas. - Google Patents

Formulaciones de factor ix liofilizadas.

Info

Publication number
CL2016002386A1
CL2016002386A1 CL2016002386A CL2016002386A CL2016002386A1 CL 2016002386 A1 CL2016002386 A1 CL 2016002386A1 CL 2016002386 A CL2016002386 A CL 2016002386A CL 2016002386 A CL2016002386 A CL 2016002386A CL 2016002386 A1 CL2016002386 A1 CL 2016002386A1
Authority
CL
Chile
Prior art keywords
fix
formulations
liofilized
polipeptide
agent
Prior art date
Application number
CL2016002386A
Other languages
English (en)
Spanish (es)
Inventor
Brian M Thome
Cherie Parkhurst-Lang
Brandon W Leveille
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
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=CL2016002386(A1) "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 CL2016002386A1 publication Critical patent/CL2016002386A1/es

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)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (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)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Genetics & Genomics (AREA)
  • Dermatology (AREA)
  • Hematology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (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)
CL2016002386A 2014-03-24 2016-09-22 Formulaciones de factor ix liofilizadas. CL2016002386A1 (es)

Applications Claiming Priority (1)

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

Publications (1)

Publication Number Publication Date
CL2016002386A1 true CL2016002386A1 (es) 2017-06-23

Family

ID=54196282

Family Applications (1)

Application Number Title Priority Date Filing Date
CL2016002386A CL2016002386A1 (es) 2014-03-24 2016-09-22 Formulaciones de factor ix liofilizadas.

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) EA202092926A3 (enExample)
IL (3) IL247869B (enExample)
MA (1) MA39779A (enExample)
MX (2) MX387269B (enExample)
PH (1) PH12016501877A1 (enExample)
SG (3) SG10201808249VA (enExample)
TW (1) TWI700101B (enExample)
WO (1) WO2015148444A1 (enExample)

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SG11201505926VA (en) 2013-03-15 2015-09-29 Biogen Ma Inc Factor ix polypeptide formulations
EA201691111A1 (ru) 2014-01-10 2017-01-30 Байоджен Ма Инк. Химерные белки фактора viii и их применение
EA202092926A3 (ru) 2014-03-24 2021-10-29 Биовератив Терапьютикс Инк. Лиофилизированные составы, содержащие фактор ix
KR20190090827A (ko) * 2016-12-02 2019-08-02 바이오버라티브 테라퓨틱스 인크. 키메라 응고 인자를 사용해 혈우병성 관절증을 치료하는 방법
JP7198264B2 (ja) * 2017-07-11 2022-12-28 ユニバーサル スタビリゼイション テクノロジーズ，インコーポレイテッド バイオ医薬品を保存するための方法
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
KR20230008759A (ko) * 2020-05-11 2023-01-16 엘커메스 파마 아일랜드 리미티드 Il-2 융합 폴리펩티드 조성물 및 그의 제조 및 사용 방법
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
JP2020063313A (ja) 2020-04-23
EA202092926A2 (ru) 2021-07-30
US20210069307A1 (en) 2021-03-11
US20250121042A1 (en) 2025-04-17
BR112016021777A2 (pt) 2017-10-03
AU2022215218B2 (en) 2025-12-18
US12128092B2 (en) 2024-10-29
PH12016501877A1 (en) 2016-12-19
EP3123090A1 (en) 2017-02-01
MX2021012939A (es) 2021-11-25
JP2022044689A (ja) 2022-03-17
AU2020202863B2 (en) 2022-09-01
TWI700101B (zh) 2020-08-01
IL247869A0 (en) 2016-11-30
JP2024053015A (ja) 2024-04-12
AU2015236340A1 (en) 2016-09-29
IL281197B (en) 2022-06-01
CA2943034A1 (en) 2015-10-01
EA038573B1 (ru) 2021-09-16
CA2943034C (en) 2022-06-14
SG10201808249VA (en) 2018-10-30
EA202092926A3 (ru) 2021-10-29
WO2015148444A1 (en) 2015-10-01
EP3123090A4 (en) 2017-12-13
MX2016012447A (es) 2017-01-06
AU2022215218A1 (en) 2022-09-01
JP2017510585A (ja) 2017-04-13
SG10201913735SA (en) 2020-03-30
US10772942B2 (en) 2020-09-15
IL281197A (en) 2021-04-29
TW201605492A (zh) 2016-02-16
JP7759978B2 (ja) 2025-10-24
AU2015236340B2 (en) 2020-02-06
JP7503583B2 (ja) 2024-06-20
JP7058940B2 (ja) 2022-04-25
US20170173122A1 (en) 2017-06-22
IL247869B (en) 2020-02-27
MA39779A (fr) 2017-02-01
NZ724351A (en) 2023-10-27
KR20160137577A (ko) 2016-11-30
AU2020202863A1 (en) 2020-05-21
IL272257B (en) 2021-03-25
MX387269B (es) 2025-03-18
SG11201607642RA (en) 2016-10-28
AR099838A1 (es) 2016-08-24
EA201691807A1 (ru) 2017-03-31
KR102385372B1 (ko) 2022-04-11

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