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DK2985033T6 - Faktor VII-sammensætning - Google Patents

Faktor VII-sammensætning Download PDF

Info

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

    • 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
    • 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)
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • 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
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/14—Hydrolases (3)
    • C12N9/48—Hydrolases (3) acting on peptide bonds (3.4)
    • C12N9/50—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25)
    • C12N9/64—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue
    • C12N9/6421—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue from mammals
    • C12N9/6424—Serine endopeptidases (3.4.21)
    • C12N9/6437—Coagulation factor VIIa (3.4.21.21)
    • 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)
    • C12Y304/21021—Coagulation 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)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • Biomedical Technology (AREA)
  • Genetics & Genomics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Biochemistry (AREA)
  • Biotechnology (AREA)
  • Microbiology (AREA)
  • Molecular Biology (AREA)
  • General Engineering & Computer Science (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)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (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
DK10734272.7T DK2445516T3 (da) 2009-06-26 2010-06-18 Faktor vii sammensætning
DK15175122.9T DK2985033T6 (da) 2009-06-26 2010-06-18 Faktor VII-sammensætning

Family Applications Before (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) EP2985033B3 (da)
JP (3) JP5706888B2 (da)
KR (1) KR101468115B1 (da)
CN (2) CN105106943A (da)
AR (1) AR077234A1 (da)
AU (1) AU2010264369B2 (da)
BR (1) BRPI1010707A2 (da)
CA (1) CA2764779C (da)
DK (2) DK2445516T3 (da)
ES (2) ES2725449T7 (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
JP4874806B2 (ja) 2003-12-01 2012-02-15 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 液体因子ｖｉｉ組成物のウイルス濾過
FR2947181B1 (fr) * 2009-06-26 2012-05-04 Lfb Biotechnologies Composition de facteur vii
WO2012090067A1 (en) 2010-12-30 2012-07-05 Lfb 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
WO2016198641A1 (en) 2015-06-12 2016-12-15 Laboratoire Francais Du Fractionnement Et Des Biotechnologies Injectable composition of factor vii and fillers
IL264208B1 (en) * 2016-07-11 2024-10-01 Opko Biologics Ltd Long-term coagulation factors and methods for their preparation
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
EP3833381B1 (en) 2019-08-15 2022-08-03 Catalyst Biosciences, Inc. Modified factor vii polypeptides for subcutaneous administration
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
WO2001012653A1 (en) * 1999-08-17 2001-02-22 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
HUE037603T2 (hu) 2002-06-21 2018-09-28 Novo Nordisk Healthcare Ag VIIa faktor polipeptideket tartalmazó stabilizált, szilárd készítmények
NZ573412A (en) * 2003-06-19 2010-09-30 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.
JP5653572B2 (ja) * 2003-08-14 2015-01-14 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 第ｖｉｉ因子ポリペプチドの液状水性医薬組成物
WO2006089954A2 (en) * 2005-02-24 2006-08-31 Novo Nordisk Health Care Ag Compounds for stabilizing factor vii polypeptide formulations
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"
EP2129686B1 (en) * 2007-03-20 2016-07-13 CSL Behring GmbH Methods for industrial scale production of therapeutic complement factor h preparations from human plasma
EP2152233A1 (en) * 2007-05-02 2010-02-17 Novo Nordisk Health Care AG High concentration factor vii polypeptide formulations comprising an aromatic preservative and an antioxidant
FR2947181B1 (fr) * 2009-06-26 2012-05-04 Lfb Biotechnologies Composition de facteur vii

Also Published As

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

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