DK2985033T6 - Faktor VII-sammensætning - Google Patents

Faktor VII-sammensætning Download PDF

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Publication number
DK2985033T6
DK2985033T6 DK15175122.9T DK15175122T DK2985033T6 DK 2985033 T6 DK2985033 T6 DK 2985033T6 DK 15175122 T DK15175122 T DK 15175122T DK 2985033 T6 DK2985033 T6 DK 2985033T6
Authority
DK
Denmark
Prior art keywords
factor vii
vii composition
composition
factor
vii
Prior art date
Application number
DK15175122.9T
Other languages
English (en)
Other versions
DK2985033T3 (da
Inventor
Annie Bardat
Cornelius Pompe
Original Assignee
Lab Francais Du Fractionnement
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 Lab Francais Du Fractionnement filed Critical Lab Francais Du Fractionnement
Publication of DK2985033T3 publication Critical patent/DK2985033T3/da
Application granted granted Critical
Publication of DK2985033T6 publication Critical patent/DK2985033T6/da

Links

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)
    • 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
    • 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
    • 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)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Genetics & Genomics (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • Biomedical Technology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • General Engineering & Computer Science (AREA)
  • Biotechnology (AREA)
  • Microbiology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Dermatology (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)
DK15175122.9T 2009-06-26 2010-06-18 Faktor VII-sammensætning DK2985033T6 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR0954390A FR2947181B1 (fr) 2009-06-26 2009-06-26 Composition de facteur vii
EP10734272.7A EP2445516B1 (fr) 2009-06-26 2010-06-18 Composition de facteur vii

Publications (2)

Publication Number Publication Date
DK2985033T3 DK2985033T3 (da) 2019-06-17
DK2985033T6 true DK2985033T6 (da) 2022-11-07

Family

ID=41620211

Family Applications (2)

Application Number Title Priority Date Filing Date
DK15175122.9T DK2985033T6 (da) 2009-06-26 2010-06-18 Faktor VII-sammensætning
DK10734272.7T DK2445516T3 (da) 2009-06-26 2010-06-18 Faktor vii sammensætning

Family Applications After (1)

Application Number Title Priority Date Filing Date
DK10734272.7T DK2445516T3 (da) 2009-06-26 2010-06-18 Faktor vii sammensætning

Country Status (17)

Country Link
US (3) US9029316B2 (da)
EP (2) EP2445516B1 (da)
JP (3) JP5706888B2 (da)
KR (1) KR101468115B1 (da)
CN (2) CN102458455B (da)
AR (1) AR077234A1 (da)
AU (1) AU2010264369B2 (da)
BR (1) BRPI1010707A2 (da)
CA (1) CA2764779C (da)
DK (2) DK2985033T6 (da)
ES (2) ES2550269T3 (da)
FR (2) FR2947181B1 (da)
IL (1) IL216872A (da)
NL (1) NL301213I2 (da)
PL (2) PL2445516T3 (da)
TR (1) TR201906145T4 (da)
WO (1) WO2010149907A1 (da)

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
BRPI0416950B8 (pt) 2003-12-01 2021-05-25 Novo Nordisk Healthcare Ag métodos para remover vírus de uma composição do fator vii líquida, para inativar vírus em uma composição do fator vii líquida, e para eliminar em alto nível a presença de vírus ativos em uma composição do fator vii líquida.
FR2947181B1 (fr) * 2009-06-26 2012-05-04 Lfb Biotechnologies Composition de facteur vii
CN112076330B (zh) 2010-12-30 2023-06-02 法国化学与生物科技实验室 作为病原体灭活剂的二元醇
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
WO2016198641A1 (en) 2015-06-12 2016-12-15 Laboratoire Francais Du Fractionnement Et Des Biotechnologies Injectable composition of factor vii and fillers
KR20240006077A (ko) * 2016-07-11 2024-01-12 옵코 바이오로직스 리미티드 지속성 응고 인자 vii 및 그 제조 방법
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
WO2021030787A1 (en) 2019-08-15 2021-02-18 Catalyst Biosciences, Inc. Modified factor vii polypeptides for subcutaneous administration and on-demand treatment
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
DE122007000007I2 (de) 1986-04-09 2010-12-30 Genzyme Corp Genetisch transformierte Tiere, die ein gewünschtes Protein in Milch absondern
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
AU6558400A (en) * 1999-08-17 2001-03-13 Novo Nordisk A/S Stabilisation of freeze-dried cake
DE60143292D1 (de) * 2000-05-03 2010-12-02 Novo Nordisk Healthcare Ag Varianten des menschlichen Koagulationsfaktors VII
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
BRPI0311959B8 (pt) 2002-06-21 2021-05-25 Novo Nordisk Healthcare Ag composição, métodos para preparar um polipeptídeo estável do fator vii, e para tratar uma síndrome responsiva do fator vii, e, uso do polipeptídeo do fator vii
MXPA05013769A (es) * 2003-06-19 2006-03-08 Maxygen Holdings Ltd Variantes del dominio gla del factor vii o viia.
FR2857267B1 (fr) 2003-07-09 2006-03-10 Lab Francais Du Fractionnement Formulation stabilisante et solubilisante pour les proteines cryoprecipitables.
CN102872451A (zh) * 2003-08-14 2013-01-16 诺和诺德医疗保健公司 因子vii多肽类的含水液体药物组合物
WO2006089954A2 (en) * 2005-02-24 2006-08-31 Novo Nordisk Health Care Ag Compounds for stabilizing factor vii polypeptide formulations
RU2440810C2 (ru) * 2005-04-28 2012-01-27 Ново Нордиск Хелс Кеа Аг Закрытый контейнер, содержащий активированный полипептид фактора vii, способы его получения и набор и способ применения набора
US20090017007A1 (en) * 2005-08-26 2009-01-15 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.
CA2673260A1 (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"
ES2595059T3 (es) * 2007-03-20 2016-12-27 Csl Behring Gmbh Métodos para la producción a escala industrial de preparados terapéuticos del Factor H del complemento a partir de plasma humano
JP2010525034A (ja) * 2007-05-02 2010-07-22 ノボ ノルディスク ヘルス ケア アーゲー 芳香族保存料及び抗酸化剤を含有してなる高濃縮第vii因子ポリペプチド製剤
FR2947181B1 (fr) * 2009-06-26 2012-05-04 Lfb Biotechnologies Composition de facteur vii

Also Published As

Publication number Publication date
CA2764779A1 (fr) 2010-12-29
AU2010264369A1 (en) 2012-01-19
EP2985033B3 (fr) 2022-10-26
IL216872A (en) 2017-07-31
US9968662B2 (en) 2018-05-15
FR2947181B1 (fr) 2012-05-04
US20150216951A1 (en) 2015-08-06
US20120087908A1 (en) 2012-04-12
US20160271233A1 (en) 2016-09-22
NL301213I2 (nl) 2023-12-14
NL301213I1 (da) 2023-01-18
KR20120047918A (ko) 2012-05-14
ES2550269T3 (es) 2015-11-05
US9029316B2 (en) 2015-05-12
AR077234A1 (es) 2011-08-10
FR2947181A1 (fr) 2010-12-31
ES2725449T3 (es) 2019-09-24
JP2012530770A (ja) 2012-12-06
JP2015134795A (ja) 2015-07-27
JP5706888B2 (ja) 2015-04-22
CN105106943A (zh) 2015-12-02
CN102458455A (zh) 2012-05-16
TR201906145T4 (tr) 2019-05-21
PL2445516T3 (pl) 2015-12-31
PL2985033T3 (pl) 2019-08-30
EP2445516B1 (fr) 2015-08-12
WO2010149907A1 (fr) 2010-12-29
EP2445516A1 (fr) 2012-05-02
DK2445516T3 (da) 2015-10-19
US9358275B2 (en) 2016-06-07
ES2725449T7 (es) 2022-12-20
BRPI1010707A2 (pt) 2016-03-15
JP2017081978A (ja) 2017-05-18
AU2010264369B2 (en) 2013-06-27
DK2985033T3 (da) 2019-06-17
CN102458455B (zh) 2015-04-08
IL216872A0 (en) 2012-02-29
EP2985033A1 (fr) 2016-02-17
FR23C1001I1 (fr) 2023-03-10
EP2985033B1 (fr) 2019-03-20
KR101468115B1 (ko) 2014-12-03
CA2764779C (fr) 2015-09-29

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