WO2008015339A3 - Composition de facteur vii recombinant - Google Patents

Composition de facteur vii recombinant Download PDF

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Publication number
WO2008015339A3
WO2008015339A3 PCT/FR2007/001324 FR2007001324W WO2008015339A3 WO 2008015339 A3 WO2008015339 A3 WO 2008015339A3 FR 2007001324 W FR2007001324 W FR 2007001324W WO 2008015339 A3 WO2008015339 A3 WO 2008015339A3
Authority
WO
WIPO (PCT)
Prior art keywords
composition
factor vii
recombinant factor
vii composition
glycan
Prior art date
Application number
PCT/FR2007/001324
Other languages
English (en)
Other versions
WO2008015339A2 (fr
Inventor
Abdessatar Sami Chtourou
Emmanuel Nony
Nicolas Bihoreau
Original Assignee
Lfb Biotechnologies
Abdessatar Sami Chtourou
Emmanuel Nony
Nicolas Bihoreau
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=37903443&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=WO2008015339(A3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority to US12/374,269 priority Critical patent/US20090239788A1/en
Priority to AU2007280330A priority patent/AU2007280330B2/en
Priority to EP07823378A priority patent/EP2049150A2/fr
Priority to BRPI0715420-8A priority patent/BRPI0715420A2/pt
Priority to JP2009522304A priority patent/JP5653619B2/ja
Application filed by Lfb Biotechnologies, Abdessatar Sami Chtourou, Emmanuel Nony, Nicolas Bihoreau filed Critical Lfb Biotechnologies
Priority to CA2658800A priority patent/CA2658800C/fr
Priority to KR1020097001954A priority patent/KR101233630B1/ko
Publication of WO2008015339A2 publication Critical patent/WO2008015339A2/fr
Publication of WO2008015339A3 publication Critical patent/WO2008015339A3/fr
Priority to IL196379A priority patent/IL196379A/en
Priority to US13/705,948 priority patent/US20130189244A1/en

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
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/36—Blood coagulation or fibrinolysis factors
    • 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
    • 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
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/745—Blood coagulation or fibrinolysis factors
    • 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
    • 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)
    • C12N9/647—Blood coagulation factors not provided for in a preceding group or according to more than one of the proceeding groups
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12P—FERMENTATION OR ENZYME-USING PROCESSES TO SYNTHESISE A DESIRED CHEMICAL COMPOUND OR COMPOSITION OR TO SEPARATE OPTICAL ISOMERS FROM A RACEMIC MIXTURE
    • C12P21/00—Preparation of peptides or proteins
    • 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)
    • A—HUMAN NECESSITIES
    • A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01K—ANIMAL HUSBANDRY; AVICULTURE; APICULTURE; PISCICULTURE; FISHING; REARING OR BREEDING ANIMALS, NOT OTHERWISE PROVIDED FOR; NEW BREEDS OF ANIMALS
    • A01K2217/00—Genetically modified animals
    • A01K2217/05—Animals comprising random inserted nucleic acids (transgenic)
    • A—HUMAN NECESSITIES
    • A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01K—ANIMAL HUSBANDRY; AVICULTURE; APICULTURE; PISCICULTURE; FISHING; REARING OR BREEDING ANIMALS, NOT OTHERWISE PROVIDED FOR; NEW BREEDS OF ANIMALS
    • A01K2227/00—Animals characterised by species
    • A01K2227/10—Mammal
    • A01K2227/107—Rabbit
    • A—HUMAN NECESSITIES
    • A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01K—ANIMAL HUSBANDRY; AVICULTURE; APICULTURE; PISCICULTURE; FISHING; REARING OR BREEDING ANIMALS, NOT OTHERWISE PROVIDED FOR; NEW BREEDS OF ANIMALS
    • A01K2267/00—Animals characterised by purpose
    • A01K2267/01—Animal expressing industrially exogenous proteins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Zoology (AREA)
  • Genetics & Genomics (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Wood Science & Technology (AREA)
  • General Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Biochemistry (AREA)
  • Medicinal Chemistry (AREA)
  • Molecular Biology (AREA)
  • General Engineering & Computer Science (AREA)
  • Microbiology (AREA)
  • Biotechnology (AREA)
  • Hematology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Toxicology (AREA)
  • Biophysics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Diabetes (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Immunology (AREA)
  • Epidemiology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

La présente invention concerne une composition de facteur VII recombinant ou transgénique, chaque molécule de facteur VII de la composition comportant des formes glycanniques liées aux sites de N-glycosylation, dans laquelle parmi toutes les molécules de facteur VII de ladite composition, des formes glycanniques biantennées, bisialylées et non fucosylées sont majoritaires. L'invention concerne également une telle composition pour son utilisation comme médicament, et, également, un procédé permettant de préparer entre autres ladite composition.
PCT/FR2007/001324 2006-08-01 2007-07-31 Composition de facteur vii recombinant WO2008015339A2 (fr)

Priority Applications (9)

Application Number Priority Date Filing Date Title
KR1020097001954A KR101233630B1 (ko) 2006-08-01 2007-07-31 바이안테너리 비아시알릴화 및 비푸코실화된 형태의 다수의글리칸을 가지는 재조합 또는 형질전환 인자 ⅶ 화합물
AU2007280330A AU2007280330B2 (en) 2006-08-01 2007-07-31 Recombinant Factor VII composition
EP07823378A EP2049150A2 (fr) 2006-08-01 2007-07-31 Composition de facteur vii recombinant
BRPI0715420-8A BRPI0715420A2 (pt) 2006-08-01 2007-07-31 fator recombinante ou transgÊnico vii contendo uma maior parte de formas de glicano, formas biantenÁrias, bissialiladas e nço fucosiladas
JP2009522304A JP5653619B2 (ja) 2006-08-01 2007-07-31 遺伝子組み換えあるいは形質転換ｆｖｉｉ組成物およびその組成物を有効成分とする医薬
US12/374,269 US20090239788A1 (en) 2006-08-01 2007-07-31 Recombinant or transgenic factor vii compound having a majority of glycan, biantennary, bisialylated and non-fucosylated forms
CA2658800A CA2658800C (fr) 2006-08-01 2007-07-31 Composition de facteur vii recombinant ou transgenique comportant une majorite de formes glycanniques, biantennees, bisialylees et non fucosylees
IL196379A IL196379A (en) 2006-08-01 2009-01-07 Process for Preparing a Recombinant or Transgenic Factor Factor Composition with Most Glycan, Biantenary, Bisyaltic and Non-Focosylated Forms
US13/705,948 US20130189244A1 (en) 2006-08-01 2012-12-05 Recombinant or transgenic factor vii compound having a majority of glycan, biantennary, bisialylated and non-fucosylated forms

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR0607016 2006-08-01
FR0607016A FR2904558B1 (fr) 2006-08-01 2006-08-01 "composition de facteur vii recombinant ou transgenique, presentant majoritairement des formes glycanniques biantennees, bisialylees et non fucosylees"

Related Child Applications (1)

Application Number Title Priority Date Filing Date
US13/705,948 Division US20130189244A1 (en) 2006-08-01 2012-12-05 Recombinant or transgenic factor vii compound having a majority of glycan, biantennary, bisialylated and non-fucosylated forms

Publications (2)

Publication Number Publication Date
WO2008015339A2 WO2008015339A2 (fr) 2008-02-07
WO2008015339A3 true WO2008015339A3 (fr) 2008-04-17

Family

ID=37903443

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/FR2007/001324 WO2008015339A2 (fr) 2006-08-01 2007-07-31 Composition de facteur vii recombinant

Country Status (13)

Country Link
US (2) US20090239788A1 (fr)
EP (1) EP2049150A2 (fr)
JP (2) JP5653619B2 (fr)
KR (1) KR101233630B1 (fr)
CN (2) CN101495133A (fr)
AR (2) AR062162A1 (fr)
AU (1) AU2007280330B2 (fr)
BR (1) BRPI0715420A2 (fr)
CA (2) CA2658800C (fr)
FR (1) FR2904558B1 (fr)
IL (1) IL196379A (fr)
TW (1) TWI391400B (fr)
WO (1) WO2008015339A2 (fr)

Families Citing this family (11)

* 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
FR2901707B1 (fr) 2006-05-31 2017-09-29 Lab Francais Du Fractionnement Composition de facteur vii recombinant ou transgenique, chaque molecule de facteur vii possedant deux sites de n-glycosylation a motifs glycanniques definis
FR2915398B1 (fr) * 2007-04-25 2012-12-28 Lab Francais Du Fractionnement "ensemble de moyens pour le traitement d'une pathologie maligne, d'une maladie auto-immune ou d'une maladie infectieuse"
CA2719459A1 (fr) * 2008-03-25 2009-10-01 Bioprotein Technologies Sa Lapins transgeniques producteurs de facteur vii humain
FR2933496B1 (fr) * 2008-07-02 2012-10-05 Lfb Biotechnologies Procede de mesure du taux de facteur vii active dans un echantillon
WO2013017555A1 (fr) 2011-08-01 2013-02-07 Lfb-Biotechnologies Compositions de facteur vii ayant une glycosylation spécifique pour une demi-vie régulée
EP2554161A1 (fr) 2011-08-02 2013-02-06 LFB Biotechnologies Composition pharmaceutique comprenant factor VII encapsulé dans des micelles
WO2013114164A1 (fr) * 2012-01-30 2013-08-08 Dr. Reddy's Laboratories Limited Procédé d'obtention d'une composition glycoprotéique ayant une concentration accrue d'afucosylation
EP2956003A2 (fr) 2013-02-13 2015-12-23 Laboratoire Français du Fractionnement et des Biotechnologies Protéines à glycosylation modifiée et leurs procédés de production
EP2956480B1 (fr) 2013-02-13 2019-09-04 Laboratoire Français du Fractionnement et des Biotechnologies Anticorps anti-tnf alpha hautement galactosylés et leurs utilisations
WO2016089919A1 (fr) 2014-12-01 2016-06-09 Amgen Inc. Procédé de manipulation du taux de contenu de glycane d'une glycoprotéine

Citations (4)

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Publication number Priority date Publication date Assignee Title
EP0475354A2 (fr) * 1990-09-11 1992-03-18 BEHRINGWERKE Aktiengesellschaft Sialysation des glycoprotéines par technologie génétique
WO2001058935A2 (fr) * 2000-02-11 2001-08-16 Maxygen Aps MOLECULES DE TYPE FACTEUR VII OU VIIa
WO2005024006A2 (fr) * 2003-09-09 2005-03-17 Novo Nordisk Health Care Ag Polypeptides du facteur vii de coagulation
WO2006004675A2 (fr) * 2004-06-25 2006-01-12 Altor Bioscience Corporation Production d'un facteur tissulaire chez des plantes

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US4229342A (en) * 1977-05-18 1980-10-21 Rhone-Poulenc Industries Process for extracting proteins from milk using silica and anion exchange resins
NL8204923A (nl) * 1982-12-21 1984-07-16 Stichting Nl I Zuivelonderzoek Werkwijze voor het bereiden van een precipitaat van caseine en wei-eiwit alsmede aldus bereid precipitaat.
EP0264166B1 (fr) * 1986-04-09 1996-08-21 Genzyme Corporation Animaux transformés génétiquement sécrétant une protéine désirée dans le lait
FR2632524B1 (fr) * 1988-06-09 1992-03-13 Fondation Nale Transfusion San Procede de preparation d'une fraction concentree en facteur viia et son application a titre de medicament
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FR2684999A1 (fr) * 1991-12-16 1993-06-18 Aquitaine Dev Transf Sanguine Procede de fabrication d'un concentre de facteur vii active de haute purete essentiellement depourvu des facteurs vitamine k dependants et des facteurs viiic et viiicag.
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Publication number Priority date Publication date Assignee Title
EP0475354A2 (fr) * 1990-09-11 1992-03-18 BEHRINGWERKE Aktiengesellschaft Sialysation des glycoprotéines par technologie génétique
WO2001058935A2 (fr) * 2000-02-11 2001-08-16 Maxygen Aps MOLECULES DE TYPE FACTEUR VII OU VIIa
WO2005024006A2 (fr) * 2003-09-09 2005-03-17 Novo Nordisk Health Care Ag Polypeptides du facteur vii de coagulation
WO2006004675A2 (fr) * 2004-06-25 2006-01-12 Altor Bioscience Corporation Production d'un facteur tissulaire chez des plantes

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Title
BJOERN S ET AL: "HUMAN PLASMA AND RECOMBINANT FACTOR VII CHARACTERIZATION OF O-GLYCOSYLATIONS AT SERINE RESIDUES 52 AND 60 AND EFFECTS OF SITE-DIRECTED MUTAGENESIS OF SERINE 52 TO ALANINE", JOURNAL OF BIOLOGICAL CHEMISTRY, AMERICAN SOCIETY OF BIOLOCHEMICAL BIOLOGISTS, BIRMINGHAM,, US, vol. 266, no. 17, 1991, pages 11051 - 11057, XP001086550, ISSN: 0021-9258 *
BOLT G ET AL: "POSTTRANSLATIONAL N-GLYCOSYLATION TAKES PLACE DURING THE NORMAL PROCESSING OF HUMAN COAGULATION FACTOR VII", GLYCOBIOLOGY, IRL PRESS,, GB, vol. 15, no. 5, May 2005 (2005-05-01), pages 541 - 547, XP009061442, ISSN: 0959-6658 *
JURLANDER B ET AL: "RECOMBINANT ACTIVATED FACTOR VII (RFVIIA): CHARACTERIZATION, MANUFACTURING, ND CLINICAL DEVELOPMENT", SEMINARS IN THROMBOSIS AND HEMOSTASIS, STUTTGART, DE, vol. 27, no. 4, August 2001 (2001-08-01), pages 373 - 383, XP008005254, ISSN: 0094-6176 *
THIM L ET AL: "Amino acid sequence and posttranslational modifications of human factor VII-a from plasma and transfected baby hamster kidney cells", BIOCHEMISTRY, AMERICAN CHEMICAL SOCIETY. EASTON, PA, US, vol. 27, no. 20, 1988, pages 7785 - 7793, XP002203678, ISSN: 0006-2960 *

Also Published As

Publication number Publication date
EP2049150A2 (fr) 2009-04-22
FR2904558A1 (fr) 2008-02-08
JP2009545575A (ja) 2009-12-24
JP5653619B2 (ja) 2015-01-14
AU2007280330A1 (en) 2008-02-07
AU2007280330B2 (en) 2011-11-10
CA2658800A1 (fr) 2008-02-07
CN103397011A (zh) 2013-11-20
CA2658800C (fr) 2015-03-31
CN103397011B (zh) 2016-10-05
CA2876621A1 (fr) 2008-02-07
CN101495133A (zh) 2009-07-29
US20090239788A1 (en) 2009-09-24
TWI391400B (zh) 2013-04-01
TW200825102A (en) 2008-06-16
US20130189244A1 (en) 2013-07-25
BRPI0715420A2 (pt) 2013-07-02
AR062162A1 (es) 2008-10-22
KR20090040892A (ko) 2009-04-27
AR103027A2 (es) 2017-04-12
WO2008015339A2 (fr) 2008-02-07
FR2904558B1 (fr) 2008-10-17
IL196379A0 (en) 2011-08-01
JP2015042678A (ja) 2015-03-05
IL196379A (en) 2016-04-21
KR101233630B1 (ko) 2013-02-18

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