ES2550269T3 - Composición de factor VII - Google Patents
Composición de factor VII Download PDFInfo
- Publication number
- ES2550269T3 ES2550269T3 ES10734272.7T ES10734272T ES2550269T3 ES 2550269 T3 ES2550269 T3 ES 2550269T3 ES 10734272 T ES10734272 T ES 10734272T ES 2550269 T3 ES2550269 T3 ES 2550269T3
- Authority
- ES
- Spain
- Prior art keywords
- months
- factor vii
- formulation
- fvii
- lyophilization
- 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
Links
- 108010023321 Factor VII Proteins 0.000 title abstract description 18
- 229940012413 factor vii Drugs 0.000 title abstract description 18
- 102100023804 Coagulation factor VII Human genes 0.000 title abstract description 17
- 239000000203 mixture Substances 0.000 title description 38
- 239000007788 liquid Substances 0.000 abstract description 12
- 239000004475 Arginine Substances 0.000 abstract description 7
- ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 0.000 abstract description 7
- 239000007787 solid Substances 0.000 abstract description 7
- AGPKZVBTJJNPAG-UHFFFAOYSA-N isoleucine Natural products CCC(C)C(N)C(O)=O AGPKZVBTJJNPAG-UHFFFAOYSA-N 0.000 abstract description 5
- 229960000310 isoleucine Drugs 0.000 abstract description 5
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 abstract description 5
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 abstract description 5
- 229920000053 polysorbate 80 Polymers 0.000 abstract description 5
- 229940068968 polysorbate 80 Drugs 0.000 abstract description 5
- 239000001509 sodium citrate Substances 0.000 abstract description 5
- 229940038773 trisodium citrate Drugs 0.000 abstract description 5
- KDXKERNSBIXSRK-UHFFFAOYSA-N Lysine Natural products NCCCCC(N)C(O)=O KDXKERNSBIXSRK-UHFFFAOYSA-N 0.000 abstract description 4
- 239000004472 Lysine Substances 0.000 abstract description 4
- UXVMQQNJUSDDNG-UHFFFAOYSA-L Calcium chloride Chemical compound [Cl-].[Cl-].[Ca+2] UXVMQQNJUSDDNG-UHFFFAOYSA-L 0.000 abstract description 3
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 abstract description 3
- 229930195725 Mannitol Natural products 0.000 abstract description 3
- 239000001110 calcium chloride Substances 0.000 abstract description 3
- 229910001628 calcium chloride Inorganic materials 0.000 abstract description 3
- 239000000594 mannitol Substances 0.000 abstract description 3
- 235000010355 mannitol Nutrition 0.000 abstract description 3
- 239000008194 pharmaceutical composition Substances 0.000 abstract description 3
- 229930006000 Sucrose Natural products 0.000 abstract description 2
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 abstract description 2
- 239000005720 sucrose Substances 0.000 abstract description 2
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 abstract 2
- 229920001213 Polysorbate 20 Polymers 0.000 abstract 1
- 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 abstract 1
- 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 abstract 1
- 229940068977 polysorbate 20 Drugs 0.000 abstract 1
- 238000009472 formulation Methods 0.000 description 23
- 235000018102 proteins Nutrition 0.000 description 17
- 102000004169 proteins and genes Human genes 0.000 description 17
- 108090000623 proteins and genes Proteins 0.000 description 17
- 238000000034 method Methods 0.000 description 16
- 238000004108 freeze drying Methods 0.000 description 13
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 10
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 description 6
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 6
- 230000015556 catabolic process Effects 0.000 description 6
- 238000006731 degradation reaction Methods 0.000 description 6
- 238000001035 drying Methods 0.000 description 6
- 238000001155 isoelectric focusing Methods 0.000 description 6
- 238000012360 testing method Methods 0.000 description 6
- 238000004458 analytical method Methods 0.000 description 5
- 239000007853 buffer solution Substances 0.000 description 5
- 230000006735 deficit Effects 0.000 description 5
- 238000001514 detection method Methods 0.000 description 5
- 239000007972 injectable composition Substances 0.000 description 5
- 229940112216 novoseven Drugs 0.000 description 5
- 108010013773 recombinant FVIIa Proteins 0.000 description 5
- 238000002415 sodium dodecyl sulfate polyacrylamide gel electrophoresis Methods 0.000 description 5
- 230000000007 visual effect Effects 0.000 description 5
- 208000031220 Hemophilia Diseases 0.000 description 4
- 208000009292 Hemophilia A Diseases 0.000 description 4
- AGPKZVBTJJNPAG-WHFBIAKZSA-N L-isoleucine Chemical compound CC[C@H](C)[C@H](N)C(O)=O AGPKZVBTJJNPAG-WHFBIAKZSA-N 0.000 description 4
- 230000000052 comparative effect Effects 0.000 description 4
- YMAWOPBAYDPSLA-UHFFFAOYSA-N glycylglycine Chemical compound [NH3+]CC(=O)NCC([O-])=O YMAWOPBAYDPSLA-UHFFFAOYSA-N 0.000 description 4
- HRXKRNGNAMMEHJ-UHFFFAOYSA-K trisodium citrate Chemical compound [Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O HRXKRNGNAMMEHJ-UHFFFAOYSA-K 0.000 description 4
- 239000012905 visible particle Substances 0.000 description 4
- 206010010356 Congenital anomaly Diseases 0.000 description 3
- 108010054265 Factor VIIa Proteins 0.000 description 3
- 239000004471 Glycine Substances 0.000 description 3
- 229940012414 factor viia Drugs 0.000 description 3
- 238000001914 filtration Methods 0.000 description 3
- 238000007710 freezing Methods 0.000 description 3
- 230000008014 freezing Effects 0.000 description 3
- 230000009477 glass transition Effects 0.000 description 3
- XLYOFNOQVPJJNP-ZSJDYOACSA-N heavy water Substances [2H]O[2H] XLYOFNOQVPJJNP-ZSJDYOACSA-N 0.000 description 3
- 239000000178 monomer Substances 0.000 description 3
- 239000011780 sodium chloride Substances 0.000 description 3
- 239000000243 solution Substances 0.000 description 3
- 239000000126 substance Substances 0.000 description 3
- 239000008215 water for injection Substances 0.000 description 3
- 102100022641 Coagulation factor IX Human genes 0.000 description 2
- 108010008488 Glycylglycine Proteins 0.000 description 2
- MHAJPDPJQMAIIY-UHFFFAOYSA-N Hydrogen peroxide Chemical compound OO MHAJPDPJQMAIIY-UHFFFAOYSA-N 0.000 description 2
- 102000003992 Peroxidases Human genes 0.000 description 2
- WCUXLLCKKVVCTQ-UHFFFAOYSA-M Potassium chloride Chemical compound [Cl-].[K+] WCUXLLCKKVVCTQ-UHFFFAOYSA-M 0.000 description 2
- 235000011148 calcium chloride Nutrition 0.000 description 2
- LLSDKQJKOVVTOJ-UHFFFAOYSA-L calcium chloride dihydrate Chemical compound O.O.[Cl-].[Cl-].[Ca+2] LLSDKQJKOVVTOJ-UHFFFAOYSA-L 0.000 description 2
- 239000003153 chemical reaction reagent Substances 0.000 description 2
- 238000005345 coagulation Methods 0.000 description 2
- 230000015271 coagulation Effects 0.000 description 2
- 238000011161 development Methods 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 229940043257 glycylglycine Drugs 0.000 description 2
- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 description 2
- 239000012528 membrane Substances 0.000 description 2
- 238000013508 migration Methods 0.000 description 2
- 230000005012 migration Effects 0.000 description 2
- RZJRJXONCZWCBN-UHFFFAOYSA-N octadecane Chemical compound CCCCCCCCCCCCCCCCCC RZJRJXONCZWCBN-UHFFFAOYSA-N 0.000 description 2
- 239000002245 particle Substances 0.000 description 2
- 108040007629 peroxidase activity proteins Proteins 0.000 description 2
- SQGYOTSLMSWVJD-UHFFFAOYSA-N silver(1+) nitrate Chemical compound [Ag+].[O-]N(=O)=O SQGYOTSLMSWVJD-UHFFFAOYSA-N 0.000 description 2
- 239000008247 solid mixture Substances 0.000 description 2
- 239000002904 solvent Substances 0.000 description 2
- GEYOCULIXLDCMW-UHFFFAOYSA-N 1,2-phenylenediamine Chemical compound NC1=CC=CC=C1N GEYOCULIXLDCMW-UHFFFAOYSA-N 0.000 description 1
- QFVHZQCOUORWEI-UHFFFAOYSA-N 4-[(4-anilino-5-sulfonaphthalen-1-yl)diazenyl]-5-hydroxynaphthalene-2,7-disulfonic acid Chemical compound C=12C(O)=CC(S(O)(=O)=O)=CC2=CC(S(O)(=O)=O)=CC=1N=NC(C1=CC=CC(=C11)S(O)(=O)=O)=CC=C1NC1=CC=CC=C1 QFVHZQCOUORWEI-UHFFFAOYSA-N 0.000 description 1
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 description 1
- 102000011632 Caseins Human genes 0.000 description 1
- 108010076119 Caseins Proteins 0.000 description 1
- 102000016519 Coagulation factor VII Human genes 0.000 description 1
- 238000002965 ELISA Methods 0.000 description 1
- 108010076282 Factor IX Proteins 0.000 description 1
- 108010054218 Factor VIII Proteins 0.000 description 1
- 102000001690 Factor VIII Human genes 0.000 description 1
- FFEARJCKVFRZRR-BYPYZUCNSA-N L-methionine Chemical compound CSCC[C@H](N)C(O)=O FFEARJCKVFRZRR-BYPYZUCNSA-N 0.000 description 1
- 102000008192 Lactoglobulins Human genes 0.000 description 1
- 108010060630 Lactoglobulins Proteins 0.000 description 1
- 241001465754 Metazoa Species 0.000 description 1
- 102000001708 Protein Isoforms Human genes 0.000 description 1
- 108010029485 Protein Isoforms Proteins 0.000 description 1
- 108010076504 Protein Sorting Signals Proteins 0.000 description 1
- 239000012505 Superdex™ Substances 0.000 description 1
- 108010000499 Thromboplastin Proteins 0.000 description 1
- 102000002262 Thromboplastin Human genes 0.000 description 1
- 101710087237 Whey acidic protein Proteins 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- 239000000427 antigen Substances 0.000 description 1
- 102000036639 antigens Human genes 0.000 description 1
- 108091007433 antigens Proteins 0.000 description 1
- 238000000889 atomisation Methods 0.000 description 1
- 239000011575 calcium Substances 0.000 description 1
- 229910052791 calcium Inorganic materials 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 238000004587 chromatography analysis Methods 0.000 description 1
- 238000007820 coagulation assay Methods 0.000 description 1
- 229940105772 coagulation factor vii Drugs 0.000 description 1
- 238000004040 coloring Methods 0.000 description 1
- 230000018044 dehydration Effects 0.000 description 1
- 238000006297 dehydration reaction Methods 0.000 description 1
- 238000010612 desalination reaction Methods 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 238000004090 dissolution Methods 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 230000008030 elimination Effects 0.000 description 1
- 238000003379 elimination reaction Methods 0.000 description 1
- CCIVGXIOQKPBKL-UHFFFAOYSA-M ethanesulfonate Chemical compound CCS([O-])(=O)=O CCIVGXIOQKPBKL-UHFFFAOYSA-M 0.000 description 1
- 229960004222 factor ix Drugs 0.000 description 1
- 229960000301 factor viii Drugs 0.000 description 1
- 239000012634 fragment Substances 0.000 description 1
- 239000000499 gel Substances 0.000 description 1
- 238000010438 heat treatment Methods 0.000 description 1
- 239000001307 helium Substances 0.000 description 1
- 229910052734 helium Inorganic materials 0.000 description 1
- SWQJXJOGLNCZEY-UHFFFAOYSA-N helium atom Chemical compound [He] SWQJXJOGLNCZEY-UHFFFAOYSA-N 0.000 description 1
- 208000009429 hemophilia B Diseases 0.000 description 1
- 230000002008 hemorrhagic effect Effects 0.000 description 1
- 229940127121 immunoconjugate Drugs 0.000 description 1
- 230000002779 inactivation Effects 0.000 description 1
- 229910052738 indium Inorganic materials 0.000 description 1
- APFVFJFRJDLVQX-UHFFFAOYSA-N indium atom Chemical compound [In] APFVFJFRJDLVQX-UHFFFAOYSA-N 0.000 description 1
- 239000012678 infectious agent Substances 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 238000002844 melting Methods 0.000 description 1
- 230000008018 melting Effects 0.000 description 1
- 229930182817 methionine Natural products 0.000 description 1
- 235000013336 milk Nutrition 0.000 description 1
- 239000008267 milk Substances 0.000 description 1
- 210000004080 milk Anatomy 0.000 description 1
- 238000002156 mixing Methods 0.000 description 1
- 230000007170 pathology Effects 0.000 description 1
- 239000012071 phase Substances 0.000 description 1
- 239000008363 phosphate buffer Substances 0.000 description 1
- 150000003904 phospholipids Chemical class 0.000 description 1
- 239000001103 potassium chloride Substances 0.000 description 1
- 235000011164 potassium chloride Nutrition 0.000 description 1
- 238000002331 protein detection Methods 0.000 description 1
- 230000000717 retained effect Effects 0.000 description 1
- 230000002441 reversible effect Effects 0.000 description 1
- 238000000926 separation method Methods 0.000 description 1
- 229910001961 silver nitrate Inorganic materials 0.000 description 1
- 239000007790 solid phase Substances 0.000 description 1
- 238000010186 staining Methods 0.000 description 1
- 239000000758 substrate Substances 0.000 description 1
- 238000010257 thawing Methods 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 230000009261 transgenic effect Effects 0.000 description 1
- 238000000825 ultraviolet detection Methods 0.000 description 1
- 235000021247 β-casein Nutrition 0.000 description 1
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)
-
- 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
- A61K47/08—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)
- Genetics & Genomics (AREA)
- Wood Science & Technology (AREA)
- Zoology (AREA)
- Biomedical Technology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Immunology (AREA)
- Gastroenterology & Hepatology (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Biotechnology (AREA)
- Microbiology (AREA)
- Dermatology (AREA)
- General Engineering & Computer Science (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Diabetes (AREA)
- Hematology (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)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| FR0954390A FR2947181B1 (fr) | 2009-06-26 | 2009-06-26 | Composition de facteur vii |
| FR0954390 | 2009-06-26 | ||
| PCT/FR2010/051229 WO2010149907A1 (fr) | 2009-06-26 | 2010-06-18 | Composition de facteur vii |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| ES2550269T3 true ES2550269T3 (es) | 2015-11-05 |
Family
ID=41620211
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ES10734272.7T Active ES2550269T3 (es) | 2009-06-26 | 2010-06-18 | Composición de factor VII |
| ES15175122T Active ES2725449T7 (es) | 2009-06-26 | 2010-06-18 | Composición de factor VII |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ES15175122T Active ES2725449T7 (es) | 2009-06-26 | 2010-06-18 | Composición de factor VII |
Country Status (17)
| Country | Link |
|---|---|
| US (3) | US9029316B2 (enExample) |
| EP (2) | EP2445516B1 (enExample) |
| JP (3) | JP5706888B2 (enExample) |
| KR (1) | KR101468115B1 (enExample) |
| CN (2) | CN105106943A (enExample) |
| AR (1) | AR077234A1 (enExample) |
| AU (1) | AU2010264369B2 (enExample) |
| BR (1) | BRPI1010707A2 (enExample) |
| CA (1) | CA2764779C (enExample) |
| DK (2) | DK2985033T6 (enExample) |
| ES (2) | ES2550269T3 (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)
| 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 |
| US12203113B2 (en) | 2009-07-09 | 2025-01-21 | Opko Biologics Ltd. | Long-acting coagulation factors and methods of producing same |
| ES2811526T3 (es) | 2010-12-30 | 2021-03-12 | Lab Francais Du Fractionnement | Glicoles como agentes de inactivación de patógenos |
| 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 |
| FR3038517B1 (fr) | 2015-07-06 | 2020-02-28 | Laboratoire Francais Du Fractionnement Et Des Biotechnologies | Utilisation de fragments fc modifies en immunotherapie |
| MY206271A (en) | 2016-07-11 | 2024-12-06 | Opko Biologics Ltd | Long-acting coagulation factor vii and methods of producing same |
| 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 |
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| 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 |
| DE60009926T2 (de) | 1999-08-17 | 2005-04-07 | Novo Nordisk Health Care Ag | Stabilisierung von gefriergetrocknetem kuchen |
| JP4455802B2 (ja) * | 2000-05-03 | 2010-04-21 | 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 | ヒト第ｖｉｉ凝固因子変異型 |
| 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 |
| CN1671410B (zh) | 2002-06-21 | 2010-05-12 | 诺和诺德医疗保健公司 | 因子ⅶ多肽的稳定化固体组合物 |
| RU2373282C2 (ru) * | 2003-06-19 | 2009-11-20 | Байер Хелткэр Ллк | ВАРИАНТЫ ДОМЕНА GLA ФАКТОРА VII ИЛИ VIIa |
| 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 |
| US20090041747A1 (en) * | 2005-02-24 | 2009-02-12 | Novo Nordisk Health Care Ag | Compounds for Stabilizing Factor VII Polypeptide Formulations |
| CN101184474B (zh) * | 2005-04-28 | 2013-05-29 | 诺和诺德医疗保健公司 | 含有活化的凝血因子ⅶ多肽的密封容器，制备这种容器的方法，和试剂盒以及该试剂盒的使用方法 |
| 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. |
| JP2010513462A (ja) * | 2006-12-20 | 2010-04-30 | バイエル・ヘルスケア・エルエルシー | 第ＶＩＩおよび第ＶＩＩａ因子組成物 |
| 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 |
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