CA2764779C - Composition de facteur vii - Google Patents

Composition de facteur vii Download PDF

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Publication number
CA2764779C
CA2764779C CA2764779A CA2764779A CA2764779C CA 2764779 C CA2764779 C CA 2764779C CA 2764779 A CA2764779 A CA 2764779A CA 2764779 A CA2764779 A CA 2764779A CA 2764779 C CA2764779 C CA 2764779C
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CA
Canada
Prior art keywords
composition
factor vii
composition according
factor
formulation
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
CA2764779A
Other languages
English (en)
French (fr)
Other versions
CA2764779A1 (fr
Inventor
Annie Bardat
Cornelius Pompe
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.)
LFB SA
Original Assignee
LFB SA
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
Application filed by LFB SA filed Critical LFB SA
Publication of CA2764779A1 publication Critical patent/CA2764779A1/fr
Application granted granted Critical
Publication of CA2764779C publication Critical patent/CA2764779C/fr
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • 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)
    • 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
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • 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
    • 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
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/14Hydrolases (3)
    • C12N9/48Hydrolases (3) acting on peptide bonds (3.4)
    • C12N9/50Proteinases, e.g. Endopeptidases (3.4.21-3.4.25)
    • C12N9/64Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue
    • C12N9/6421Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue from mammals
    • C12N9/6424Serine endopeptidases (3.4.21)
    • C12N9/6437Coagulation factor VIIa (3.4.21.21)
    • 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)
    • C12Y304/21021Coagulation factor VIIa (3.4.21.21)

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Zoology (AREA)
  • Biomedical Technology (AREA)
  • Wood Science & Technology (AREA)
  • Genetics & Genomics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Microbiology (AREA)
  • Molecular Biology (AREA)
  • Biotechnology (AREA)
  • Dermatology (AREA)
  • Biochemistry (AREA)
  • General Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Peptides Or Proteins (AREA)
CA2764779A 2009-06-26 2010-06-18 Composition de facteur vii Active CA2764779C (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
FR0954390 2009-06-26
FR0954390A FR2947181B1 (fr) 2009-06-26 2009-06-26 Composition de facteur vii
PCT/FR2010/051229 WO2010149907A1 (fr) 2009-06-26 2010-06-18 Composition de facteur vii

Publications (2)

Publication Number Publication Date
CA2764779A1 CA2764779A1 (fr) 2010-12-29
CA2764779C true CA2764779C (fr) 2015-09-29

Family

ID=41620211

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2764779A Active CA2764779C (fr) 2009-06-26 2010-06-18 Composition de facteur vii

Country Status (17)

Country Link
US (3) US9029316B2 (enExample)
EP (2) EP2445516B1 (enExample)
JP (3) JP5706888B2 (enExample)
KR (1) KR101468115B1 (enExample)
CN (2) CN102458455B (enExample)
AR (1) AR077234A1 (enExample)
AU (1) AU2010264369B2 (enExample)
BR (1) BRPI1010707A2 (enExample)
CA (1) CA2764779C (enExample)
DK (2) DK2985033T6 (enExample)
ES (2) ES2725449T7 (enExample)
FR (2) FR2947181B1 (enExample)
IL (1) IL216872A (enExample)
NL (1) NL301213I2 (enExample)
PL (2) PL2985033T3 (enExample)
TR (1) TR201906145T4 (enExample)
WO (1) WO2010149907A1 (enExample)

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PL1711513T3 (pl) 2003-12-01 2014-12-31 Novo Nordisk Healthcare Ag Nanofiltracja roztworów czynnika vii w celu usunięcia wirusów
FR2947181B1 (fr) * 2009-06-26 2012-05-04 Lfb Biotechnologies Composition de facteur vii
US12203113B2 (en) 2009-07-09 2025-01-21 Opko Biologics Ltd. Long-acting coagulation factors and methods of producing same
PH12013501365A1 (en) 2010-12-30 2013-09-16 Laboratoire Francais Du Fractionnment Et Des Biotechnologies Glycols as pathogen inactivating agents
EP2687595B1 (en) 2012-07-19 2018-05-30 Laboratoire Français du Fractionnement et des Biotechnologies Method for purifying transgenic factor VII
FR3006591B1 (fr) 2013-06-11 2016-05-06 Lab Francais Du Fractionnement Composition de facteur vii presentant un point isoelectrique substantiellement homogene
US20180169297A1 (en) 2015-06-12 2018-06-21 Laboratoire Français Du Fractionnement Et Des Biotechnologies Injectable composition of factor vii and fillers
FR3038517B1 (fr) 2015-07-06 2020-02-28 Laboratoire Francais Du Fractionnement Et Des Biotechnologies Utilisation de fragments fc modifies en immunotherapie
TW202444744A (zh) * 2016-07-11 2024-11-16 以色列商歐科生物製品有限公司 長效型凝血因子及其生產方法
FR3082427B1 (fr) 2018-06-14 2020-09-25 Lab Francais Du Fractionnement Combinaison de facteur vii et d'un anticorps bispecifique anti-facteurs ix et x
CN114728044A (zh) 2019-08-15 2022-07-08 介控生化科技公司 用于皮下施用和按需求治疗的经修饰的因子vii多肽
CN117860874B (zh) * 2024-03-12 2024-07-02 正大天晴药业集团南京顺欣制药有限公司 重组人凝血因子VIIa的药物组合物

Family Cites Families (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GR860984B (en) 1985-04-17 1986-08-18 Zymogenetics Inc Expression of factor vii and ix activities in mammalian cells
JP2874751B2 (ja) 1986-04-09 1999-03-24 ジェンザイム・コーポレーション 希望する蛋白質をミルク中へ分泌する遺伝子移植動物
JP3543144B2 (ja) * 1995-03-11 2004-07-14 国際試薬株式会社 臨床検査用製剤
DE19538687A1 (de) * 1995-10-17 1997-04-24 Boehringer Mannheim Gmbh Stabile pharmazeutische Darreichungsformen enthaltend Parathormon
WO2001012653A1 (en) * 1999-08-17 2001-02-22 Novo Nordisk A/S Stabilisation of freeze-dried cake
AU2001254624A1 (en) * 2000-05-03 2001-11-12 Novo-Nordisk A/S Human coagulation factor vii variants
JP2005526004A (ja) * 2001-11-09 2005-09-02 ノボ ノルディスク ヘルス ケア アクチェンゲゼルシャフト 第vii因子ポリペプチドおよびトラネキサム酸を含む薬学的組成物
PL207018B1 (pl) 2002-06-21 2010-10-29 Novo Nordisk Helth Care Ag Kompozycja farmaceutyczna, sposób przygotowania stabilnego polipeptydu czynnika VII i zastosowanie polipeptydu czynnika VII
WO2004111242A1 (en) * 2003-06-19 2004-12-23 Maxygen Holdings Ltd. FACTOR VII OR VIIa GLA DOMAIN VARIANTS
FR2857267B1 (fr) * 2003-07-09 2006-03-10 Lab Francais Du Fractionnement Formulation stabilisante et solubilisante pour les proteines cryoprecipitables.
RU2388460C2 (ru) * 2003-08-14 2010-05-10 Ново Нордиск Хелс Кеа Аг Жидкая водная фармацевтическая композиция, содержащая полипептид фактора vii
JP2008531525A (ja) * 2005-02-24 2008-08-14 ノボ ノルディスク ヘルス ケア アクチェンゲゼルシャフト Vii因子ポリペプチド製剤を安定化する化合物
KR101364003B1 (ko) * 2005-04-28 2014-02-21 노보 노르디스크 헬스 케어 악티엔게젤샤프트 활성화된 제vii 인자 폴리펩타이드를 포함하는 밀폐용기와 이의 제조방법 및, 키트와 키트의 사용방법
EP1919498A2 (en) * 2005-08-26 2008-05-14 Maxygen Holdings Ltd. Liquid factor vii composition
FR2894831B1 (fr) * 2005-12-16 2008-02-15 Lab Francais Du Fractionnement Colle biologique exempte de thrombine et son utilisation comme medicament.
WO2008078189A2 (en) * 2006-12-20 2008-07-03 Bayer Healthcare Llc Factor vii and viia compositions
FR2910786B1 (fr) 2006-12-29 2017-08-11 Laboratoire Francais Du Fractionnement Et Des Biotechnologies (Lfb) "procede d'extraction d'une proteine presente dans du lait"
WO2008113589A1 (en) * 2007-03-20 2008-09-25 Csl Behring Gmbh Methods for industrial scale production of therapeutic complement factor h preparations from human plasma
CN104887620A (zh) * 2007-05-02 2015-09-09 诺沃—诺迪斯克保健股份有限公司 包括芳香族防腐剂和抗氧化剂的高浓度因子vii多肽制剂
FR2947181B1 (fr) * 2009-06-26 2012-05-04 Lfb Biotechnologies Composition de facteur vii

Also Published As

Publication number Publication date
JP2012530770A (ja) 2012-12-06
BRPI1010707A2 (pt) 2016-03-15
US20120087908A1 (en) 2012-04-12
KR101468115B1 (ko) 2014-12-03
ES2725449T3 (es) 2019-09-24
JP2015134795A (ja) 2015-07-27
EP2985033B1 (fr) 2019-03-20
CN102458455A (zh) 2012-05-16
CN105106943A (zh) 2015-12-02
FR23C1001I2 (fr) 2025-03-28
AR077234A1 (es) 2011-08-10
US9968662B2 (en) 2018-05-15
JP5706888B2 (ja) 2015-04-22
EP2445516B1 (fr) 2015-08-12
US9358275B2 (en) 2016-06-07
US20150216951A1 (en) 2015-08-06
WO2010149907A1 (fr) 2010-12-29
IL216872A (en) 2017-07-31
EP2985033A1 (fr) 2016-02-17
EP2985033B3 (fr) 2022-10-26
FR2947181A1 (fr) 2010-12-31
FR2947181B1 (fr) 2012-05-04
AU2010264369A1 (en) 2012-01-19
AU2010264369B2 (en) 2013-06-27
KR20120047918A (ko) 2012-05-14
CN102458455B (zh) 2015-04-08
PL2985033T3 (pl) 2019-08-30
DK2985033T6 (da) 2022-11-07
FR23C1001I1 (fr) 2023-03-10
ES2550269T3 (es) 2015-11-05
US9029316B2 (en) 2015-05-12
EP2445516A1 (fr) 2012-05-02
TR201906145T4 (tr) 2019-05-21
NL301213I1 (enExample) 2023-01-18
NL301213I2 (nl) 2023-12-14
DK2985033T3 (da) 2019-06-17
CA2764779A1 (fr) 2010-12-29
JP2017081978A (ja) 2017-05-18
PL2445516T3 (pl) 2015-12-31
DK2445516T3 (en) 2015-10-19
US20160271233A1 (en) 2016-09-22
IL216872A0 (en) 2012-02-29
ES2725449T7 (es) 2022-12-20

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