NO330048B1 - Stabile faktor VIII-sammensetninger - Google Patents

Stabile faktor VIII-sammensetninger Download PDF

Info

Publication number: NO330048B1
Authority: NO; Norway
Prior art keywords: factor viii; composition according; concentration; viii; ions
Prior art date: 1999-07-13

Application number

NO20020120A

Other languages

English (en)

Norwegian (no)

Other versions

NO20020120L (no

NO20020120D0 (no

Inventor

Marianne Mikaelsson

Helena Sandberg

Original Assignee

Biovitrum Ab

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.)

1999-07-13

Filing date

2002-01-10

Publication date

2011-02-07

Family has litigation

First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=27354553&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=NO330048(B1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.

1999-07-13 Priority claimed from SE9902685A external-priority patent/SE9902685D0/xx

2000-05-11 Priority claimed from SE0001743A external-priority patent/SE0001743D0/xx

2002-01-10 Application filed by Biovitrum Ab filed Critical Biovitrum Ab

2002-01-10 Publication of NO20020120D0 publication Critical patent/NO20020120D0/no

2002-02-28 Publication of NO20020120L publication Critical patent/NO20020120L/no

2011-02-07 Publication of NO330048B1 publication Critical patent/NO330048B1/no

Links

102000001690 Factor VIII Human genes 0.000 title claims description 99
229960000301 factor viii Drugs 0.000 title claims description 93
239000000203 mixture Substances 0.000 title claims description 48
108010023321 Factor VII Proteins 0.000 title description 2
108010054218 Factor VIII Proteins 0.000 claims description 98
239000011701 zinc Substances 0.000 claims description 46
229910021645 metal ion Inorganic materials 0.000 claims description 33
108010025139 recombinant factor VIII SQ Proteins 0.000 claims description 33
230000000694 effects Effects 0.000 claims description 31
239000011575 calcium Substances 0.000 claims description 27
239000010949 copper Substances 0.000 claims description 27
150000002500 ions Chemical class 0.000 claims description 22
FAPWRFPIFSIZLT-UHFFFAOYSA-M sodium chloride Inorganic materials [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 14
150000001413 amino acids Chemical class 0.000 claims description 12
229940024606 amino acid Drugs 0.000 claims description 11
-1 polyoxyethylene Polymers 0.000 claims description 11
HNDVDQJCIGZPNO-YFKPBYRVSA-N L-histidine Chemical compound OC(=O)[C@@H](N)CC1=CN=CN1 HNDVDQJCIGZPNO-YFKPBYRVSA-N 0.000 claims description 10
239000011780 sodium chloride Substances 0.000 claims description 8
238000012217 deletion Methods 0.000 claims description 7
230000037430 deletion Effects 0.000 claims description 7
239000002736 nonionic surfactant Substances 0.000 claims description 7
239000003963 antioxidant agent Substances 0.000 claims description 6
229960002885 histidine Drugs 0.000 claims description 6
238000003860 storage Methods 0.000 claims description 6
102000009027 Albumins Human genes 0.000 claims description 5
108010088751 Albumins Proteins 0.000 claims description 5
159000000007 calcium salts Chemical class 0.000 claims description 5
239000008194 pharmaceutical composition Substances 0.000 claims description 5
229920003171 Poly (ethylene oxide) Polymers 0.000 claims description 4
WCUXLLCKKVVCTQ-UHFFFAOYSA-M Potassium chloride Chemical compound [Cl-].[K+] WCUXLLCKKVVCTQ-UHFFFAOYSA-M 0.000 claims description 4
239000007864 aqueous solution Substances 0.000 claims description 4
QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 claims description 4
150000001879 copper Chemical class 0.000 claims description 4
235000014113 dietary fatty acids Nutrition 0.000 claims description 4
239000000194 fatty acid Substances 0.000 claims description 4
229930195729 fatty acid Natural products 0.000 claims description 4
RWSXRVCMGQZWBV-WDSKDSINSA-N glutathione Chemical compound OC(=O)[C@@H](N)CCC(=O)N[C@@H](CS)C(=O)NCC(O)=O RWSXRVCMGQZWBV-WDSKDSINSA-N 0.000 claims description 4
229910052760 oxygen Inorganic materials 0.000 claims description 4
239000001301 oxygen Substances 0.000 claims description 4
DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 claims description 3
150000002016 disaccharides Chemical class 0.000 claims description 3
150000003751 zinc Chemical class 0.000 claims description 3
108010024636 Glutathione Proteins 0.000 claims description 2
PWKSKIMOESPYIA-BYPYZUCNSA-N L-N-acetyl-Cysteine Chemical compound CC(=O)N[C@@H](CS)C(O)=O PWKSKIMOESPYIA-BYPYZUCNSA-N 0.000 claims description 2
FFEARJCKVFRZRR-BYPYZUCNSA-N L-methionine Chemical compound CSCC[C@H](N)C(O)=O FFEARJCKVFRZRR-BYPYZUCNSA-N 0.000 claims description 2
229960004308 acetylcysteine Drugs 0.000 claims description 2
230000003078 antioxidant effect Effects 0.000 claims description 2
229960003180 glutathione Drugs 0.000 claims description 2
229930182817 methionine Natural products 0.000 claims description 2
229960004452 methionine Drugs 0.000 claims description 2
150000002772 monosaccharides Chemical class 0.000 claims description 2
239000001103 potassium chloride Substances 0.000 claims description 2
235000011164 potassium chloride Nutrition 0.000 claims description 2
238000000034 method Methods 0.000 description 18
101000911390 Homo sapiens Coagulation factor VIII Proteins 0.000 description 16
210000004027 cell Anatomy 0.000 description 15
238000002474 experimental method Methods 0.000 description 14
102100026735 Coagulation factor VIII Human genes 0.000 description 13
102000004169 proteins and genes Human genes 0.000 description 13
108090000623 proteins and genes Proteins 0.000 description 13
239000000047 product Substances 0.000 description 11
239000006143 cell culture medium Substances 0.000 description 10
238000004519 manufacturing process Methods 0.000 description 10
239000000243 solution Substances 0.000 description 10
239000006228 supernatant Substances 0.000 description 10
239000000872 buffer Substances 0.000 description 9
229910052751 metal Inorganic materials 0.000 description 9
239000002184 metal Substances 0.000 description 9
238000002360 preparation method Methods 0.000 description 9
JIAARYAFYJHUJI-UHFFFAOYSA-L zinc dichloride Chemical compound [Cl-].[Cl-].[Zn+2] JIAARYAFYJHUJI-UHFFFAOYSA-L 0.000 description 9
ORTQZVOHEJQUHG-UHFFFAOYSA-L copper(II) chloride Chemical compound Cl[Cu]Cl ORTQZVOHEJQUHG-UHFFFAOYSA-L 0.000 description 8
238000000746 purification Methods 0.000 description 8
238000001542 size-exclusion chromatography Methods 0.000 description 8
239000011734 sodium Substances 0.000 description 8
KCXVZYZYPLLWCC-UHFFFAOYSA-N EDTA Chemical compound OC(=O)CN(CC(O)=O)CCN(CC(O)=O)CC(O)=O KCXVZYZYPLLWCC-UHFFFAOYSA-N 0.000 description 7
208000007536 Thrombosis Diseases 0.000 description 7
HCHKCACWOHOZIP-UHFFFAOYSA-N Zinc Chemical compound [Zn] HCHKCACWOHOZIP-UHFFFAOYSA-N 0.000 description 7
NOESYZHRGYRDHS-UHFFFAOYSA-N insulin Chemical compound N1C(=O)C(NC(=O)C(CCC(N)=O)NC(=O)C(CCC(O)=O)NC(=O)C(C(C)C)NC(=O)C(NC(=O)CN)C(C)CC)CSSCC(C(NC(CO)C(=O)NC(CC(C)C)C(=O)NC(CC=2C=CC(O)=CC=2)C(=O)NC(CCC(N)=O)C(=O)NC(CC(C)C)C(=O)NC(CCC(O)=O)C(=O)NC(CC(N)=O)C(=O)NC(CC=2C=CC(O)=CC=2)C(=O)NC(CSSCC(NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC=2C=CC(O)=CC=2)NC(=O)C(CC(C)C)NC(=O)C(C)NC(=O)C(CCC(O)=O)NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC=2NC=NC=2)NC(=O)C(CO)NC(=O)CNC2=O)C(=O)NCC(=O)NC(CCC(O)=O)C(=O)NC(CCCNC(N)=N)C(=O)NCC(=O)NC(CC=3C=CC=CC=3)C(=O)NC(CC=3C=CC=CC=3)C(=O)NC(CC=3C=CC(O)=CC=3)C(=O)NC(C(C)O)C(=O)N3C(CCC3)C(=O)NC(CCCCN)C(=O)NC(C)C(O)=O)C(=O)NC(CC(N)=O)C(O)=O)=O)NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C1CSSCC2NC(=O)C(CC(C)C)NC(=O)C(NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)CC=1C=CC=CC=1)C(C)C)CC1=CN=CN1 NOESYZHRGYRDHS-UHFFFAOYSA-N 0.000 description 7
239000000463 material Substances 0.000 description 7
229910052725 zinc Inorganic materials 0.000 description 7
OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 description 6
UXVMQQNJUSDDNG-UHFFFAOYSA-L Calcium chloride Chemical compound [Cl-].[Cl-].[Ca+2] UXVMQQNJUSDDNG-UHFFFAOYSA-L 0.000 description 6
LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 description 6
239000007983 Tris buffer Substances 0.000 description 6
238000007792 addition Methods 0.000 description 6
229960005069 calcium Drugs 0.000 description 6
229910052791 calcium Inorganic materials 0.000 description 6
239000001110 calcium chloride Substances 0.000 description 6
229910001628 calcium chloride Inorganic materials 0.000 description 6
235000011148 calcium chloride Nutrition 0.000 description 6
238000011534 incubation Methods 0.000 description 6
239000011572 manganese Substances 0.000 description 6
239000002609 medium Substances 0.000 description 6
LENZDBCJOHFCAS-UHFFFAOYSA-N tris Chemical compound OCC(N)(CO)CO LENZDBCJOHFCAS-UHFFFAOYSA-N 0.000 description 6
238000004113 cell culture Methods 0.000 description 5
108090000765 processed proteins & peptides Proteins 0.000 description 5
238000011160 research Methods 0.000 description 5
235000005074 zinc chloride Nutrition 0.000 description 5
239000011592 zinc chloride Substances 0.000 description 5
RYGMFSIKBFXOCR-UHFFFAOYSA-N Copper Chemical group [Cu] RYGMFSIKBFXOCR-UHFFFAOYSA-N 0.000 description 4
229910021592 Copper(II) chloride Inorganic materials 0.000 description 4
208000009292 Hemophilia A Diseases 0.000 description 4
239000012141 concentrate Substances 0.000 description 4
238000002523 gelfiltration Methods 0.000 description 4
235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 description 4
229920001184 polypeptide Polymers 0.000 description 4
229920000053 polysorbate 80 Polymers 0.000 description 4
102000004196 processed proteins & peptides Human genes 0.000 description 4
239000012619 Butyl Sepharose® Substances 0.000 description 3
102000008100 Human Serum Albumin Human genes 0.000 description 3
108091006905 Human Serum Albumin Proteins 0.000 description 3
102000004877 Insulin Human genes 0.000 description 3
108090001061 Insulin Proteins 0.000 description 3
238000004458 analytical method Methods 0.000 description 3
210000004369 blood Anatomy 0.000 description 3
239000008280 blood Substances 0.000 description 3
210000004978 chinese hamster ovary cell Anatomy 0.000 description 3
239000000701 coagulant Substances 0.000 description 3
229910052802 copper Inorganic materials 0.000 description 3
238000010828 elution Methods 0.000 description 3
238000009472 formulation Methods 0.000 description 3
239000001963 growth medium Substances 0.000 description 3
230000023597 hemostasis Effects 0.000 description 3
102000057593 human F8 Human genes 0.000 description 3
229940125396 insulin Drugs 0.000 description 3
230000007774 longterm Effects 0.000 description 3
239000013641 positive control Substances 0.000 description 3
238000012552 review Methods 0.000 description 3
238000004114 suspension culture Methods 0.000 description 3
230000035899 viability Effects 0.000 description 3
229910021591 Copper(I) chloride Inorganic materials 0.000 description 2
201000003542 Factor VIII deficiency Diseases 0.000 description 2
208000031220 Hemophilia Diseases 0.000 description 2
XEEYBQQBJWHFJM-UHFFFAOYSA-N Iron Chemical compound [Fe] XEEYBQQBJWHFJM-UHFFFAOYSA-N 0.000 description 2
PXHVJJICTQNCMI-UHFFFAOYSA-N Nickel Chemical compound [Ni] PXHVJJICTQNCMI-UHFFFAOYSA-N 0.000 description 2
241000276498 Pollachius virens Species 0.000 description 2
229920001213 Polysorbate 20 Polymers 0.000 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 description 2
229930006000 Sucrose Natural products 0.000 description 2
238000003556 assay Methods 0.000 description 2
239000007640 basal medium Substances 0.000 description 2
230000008901 benefit Effects 0.000 description 2
230000005540 biological transmission Effects 0.000 description 2
238000005119 centrifugation Methods 0.000 description 2
239000002738 chelating agent Substances 0.000 description 2
239000003593 chromogenic compound Substances 0.000 description 2
OXBLHERUFWYNTN-UHFFFAOYSA-M copper(I) chloride Chemical compound [Cu]Cl OXBLHERUFWYNTN-UHFFFAOYSA-M 0.000 description 2
230000001186 cumulative effect Effects 0.000 description 2
231100000673 dose–response relationship Toxicity 0.000 description 2
208000031169 hemorrhagic disease Diseases 0.000 description 2
HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 description 2
229960000900 human factor viii Drugs 0.000 description 2
238000002354 inductively-coupled plasma atomic emission spectroscopy Methods 0.000 description 2
239000012678 infectious agent Substances 0.000 description 2
239000000546 pharmaceutical excipient Substances 0.000 description 2
239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 description 2
235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 description 2
239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 description 2
229940068968 polysorbate 80 Drugs 0.000 description 2
230000002797 proteolythic effect Effects 0.000 description 2
239000005720 sucrose Substances 0.000 description 2
230000009469 supplementation Effects 0.000 description 2
230000004083 survival effect Effects 0.000 description 2
238000002560 therapeutic procedure Methods 0.000 description 2
238000004448 titration Methods 0.000 description 2
230000014599 transmission of virus Effects 0.000 description 2
XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 2
239000002023 wood Substances 0.000 description 2
108010089996 B-domain-deleted factor VIII Proteins 0.000 description 1
KRKNYBCHXYNGOX-UHFFFAOYSA-K Citrate Chemical compound [O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O KRKNYBCHXYNGOX-UHFFFAOYSA-K 0.000 description 1
102100023804 Coagulation factor VII Human genes 0.000 description 1
241000699802 Cricetulus griseus Species 0.000 description 1
JPVYNHNXODAKFH-UHFFFAOYSA-N Cu2+ Chemical compound [Cu+2] JPVYNHNXODAKFH-UHFFFAOYSA-N 0.000 description 1
206010062713 Haemorrhagic diathesis Diseases 0.000 description 1
208000032843 Hemorrhage Diseases 0.000 description 1
206010023203 Joint destruction Diseases 0.000 description 1
FYYHWMGAXLPEAU-UHFFFAOYSA-N Magnesium Chemical compound [Mg] FYYHWMGAXLPEAU-UHFFFAOYSA-N 0.000 description 1
WAEMQWOKJMHJLA-UHFFFAOYSA-N Manganese(2+) Chemical compound [Mn+2] WAEMQWOKJMHJLA-UHFFFAOYSA-N 0.000 description 1
GRYLNZFGIOXLOG-UHFFFAOYSA-N Nitric acid Chemical compound O[N+]([O-])=O GRYLNZFGIOXLOG-UHFFFAOYSA-N 0.000 description 1
229910019142 PO4 Inorganic materials 0.000 description 1
108010076504 Protein Sorting Signals Proteins 0.000 description 1
229920005654 Sephadex Polymers 0.000 description 1
239000012507 Sephadex™ Substances 0.000 description 1
229920002684 Sepharose Polymers 0.000 description 1
108010022999 Serine Proteases Proteins 0.000 description 1
102000012479 Serine Proteases Human genes 0.000 description 1
108090000190 Thrombin Proteins 0.000 description 1
206010044565 Tremor Diseases 0.000 description 1
241000251539 Vertebrata <Metazoa> Species 0.000 description 1
210000001766 X chromosome Anatomy 0.000 description 1
PTFCDOFLOPIGGS-UHFFFAOYSA-N Zinc dication Chemical compound [Zn+2] PTFCDOFLOPIGGS-UHFFFAOYSA-N 0.000 description 1
230000002159 abnormal effect Effects 0.000 description 1
230000004913 activation Effects 0.000 description 1
239000000654 additive Substances 0.000 description 1
210000004102 animal cell Anatomy 0.000 description 1
239000003146 anticoagulant agent Substances 0.000 description 1
229940127219 anticoagulant drug Drugs 0.000 description 1
239000012062 aqueous buffer Substances 0.000 description 1
230000009286 beneficial effect Effects 0.000 description 1
238000002306 biochemical method Methods 0.000 description 1
208000034158 bleeding Diseases 0.000 description 1
230000000740 bleeding effect Effects 0.000 description 1
229920001400 block copolymer Polymers 0.000 description 1
239000012928 buffer substance Substances 0.000 description 1
210000004899 c-terminal region Anatomy 0.000 description 1
239000004227 calcium gluconate Substances 0.000 description 1
235000013927 calcium gluconate Nutrition 0.000 description 1
229960004494 calcium gluconate Drugs 0.000 description 1
NEEHYRZPVYRGPP-UHFFFAOYSA-L calcium;2,3,4,5,6-pentahydroxyhexanoate Chemical compound [Ca+2].OCC(O)C(O)C(O)C(O)C([O-])=O.OCC(O)C(O)C(O)C(O)C([O-])=O NEEHYRZPVYRGPP-UHFFFAOYSA-L 0.000 description 1
238000004364 calculation method Methods 0.000 description 1
150000001720 carbohydrates Chemical class 0.000 description 1
239000000969 carrier Substances 0.000 description 1
150000001768 cations Chemical class 0.000 description 1
238000012512 characterization method Methods 0.000 description 1
239000003153 chemical reaction reagent Substances 0.000 description 1
150000001805 chlorine compounds Chemical class 0.000 description 1
238000004587 chromatography analysis Methods 0.000 description 1
210000000349 chromosome Anatomy 0.000 description 1
230000001684 chronic effect Effects 0.000 description 1
230000015271 coagulation Effects 0.000 description 1
238000005345 coagulation Methods 0.000 description 1
229940105778 coagulation factor viii Drugs 0.000 description 1
229910017052 cobalt Inorganic materials 0.000 description 1
239000010941 cobalt Substances 0.000 description 1
GUTLYIVDDKVIGB-UHFFFAOYSA-N cobalt atom Chemical compound [Co] GUTLYIVDDKVIGB-UHFFFAOYSA-N 0.000 description 1
239000002299 complementary DNA Substances 0.000 description 1
239000000306 component Substances 0.000 description 1
239000003636 conditioned culture medium Substances 0.000 description 1
238000011109 contamination Methods 0.000 description 1
229910001431 copper ion Inorganic materials 0.000 description 1
210000004748 cultured cell Anatomy 0.000 description 1
230000006378 damage Effects 0.000 description 1
230000007547 defect Effects 0.000 description 1
230000007812 deficiency Effects 0.000 description 1
230000001419 dependent effect Effects 0.000 description 1
239000003599 detergent Substances 0.000 description 1
238000011161 development Methods 0.000 description 1
239000000539 dimer Substances 0.000 description 1
229940042399 direct acting antivirals protease inhibitors Drugs 0.000 description 1
238000010494 dissociation reaction Methods 0.000 description 1
230000005593 dissociations Effects 0.000 description 1
239000012153 distilled water Substances 0.000 description 1
239000002552 dosage form Substances 0.000 description 1
239000003937 drug carrier Substances 0.000 description 1
238000011067 equilibration Methods 0.000 description 1
229940012413 factor vii Drugs 0.000 description 1
239000013020 final formulation Substances 0.000 description 1
239000012467 final product Substances 0.000 description 1
238000004108 freeze drying Methods 0.000 description 1
238000001727 in vivo Methods 0.000 description 1
230000002779 inactivation Effects 0.000 description 1
238000001095 inductively coupled plasma mass spectrometry Methods 0.000 description 1
208000015181 infectious disease Diseases 0.000 description 1
239000004615 ingredient Substances 0.000 description 1
239000004026 insulin derivative Substances 0.000 description 1
238000010253 intravenous injection Methods 0.000 description 1
229910052742 iron Inorganic materials 0.000 description 1
210000001503 joint Anatomy 0.000 description 1
229910052749 magnesium Inorganic materials 0.000 description 1
239000011777 magnesium Substances 0.000 description 1
230000014759 maintenance of location Effects 0.000 description 1
150000002696 manganese Chemical class 0.000 description 1
WPBNNNQJVZRUHP-UHFFFAOYSA-L manganese(2+);methyl n-[[2-(methoxycarbonylcarbamothioylamino)phenyl]carbamothioyl]carbamate;n-[2-(sulfidocarbothioylamino)ethyl]carbamodithioate Chemical compound [Mn+2].[S-]C(=S)NCCNC([S-])=S.COC(=O)NC(=S)NC1=CC=CC=C1NC(=S)NC(=O)OC WPBNNNQJVZRUHP-UHFFFAOYSA-L 0.000 description 1
239000012533 medium component Substances 0.000 description 1
108020004999 messenger RNA Proteins 0.000 description 1
239000000693 micelle Substances 0.000 description 1
238000002156 mixing Methods 0.000 description 1
238000010369 molecular cloning Methods 0.000 description 1
229910052759 nickel Inorganic materials 0.000 description 1
229910017604 nitric acid Inorganic materials 0.000 description 1
235000015097 nutrients Nutrition 0.000 description 1
210000001672 ovary Anatomy 0.000 description 1
239000000137 peptide hydrolase inhibitor Substances 0.000 description 1
NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 description 1
239000010452 phosphate Substances 0.000 description 1
239000004033 plastic Substances 0.000 description 1
229920005862 polyol Polymers 0.000 description 1
150000003077 polyols Chemical class 0.000 description 1
229940068977 polysorbate 20 Drugs 0.000 description 1
230000004481 post-translational protein modification Effects 0.000 description 1
239000002243 precursor Substances 0.000 description 1
230000008569 process Effects 0.000 description 1
238000012545 processing Methods 0.000 description 1
230000000750 progressive effect Effects 0.000 description 1
238000011002 quantification Methods 0.000 description 1
229940047431 recombinate Drugs 0.000 description 1
238000009256 replacement therapy Methods 0.000 description 1
150000003839 salts Chemical class 0.000 description 1
238000012216 screening Methods 0.000 description 1
239000012679 serum free medium Substances 0.000 description 1
239000004017 serum-free culture medium Substances 0.000 description 1
229910052708 sodium Inorganic materials 0.000 description 1
238000001179 sorption measurement Methods 0.000 description 1
230000006641 stabilisation Effects 0.000 description 1
238000011105 stabilization Methods 0.000 description 1
239000003381 stabilizer Substances 0.000 description 1
230000000087 stabilizing effect Effects 0.000 description 1
229910052712 strontium Inorganic materials 0.000 description 1
CIOAGBVUUVVLOB-UHFFFAOYSA-N strontium atom Chemical compound [Sr] CIOAGBVUUVVLOB-UHFFFAOYSA-N 0.000 description 1
239000000126 substance Substances 0.000 description 1
150000005846 sugar alcohols Chemical class 0.000 description 1
239000000725 suspension Substances 0.000 description 1
208000024891 symptom Diseases 0.000 description 1
230000002195 synergetic effect Effects 0.000 description 1
238000010998 test method Methods 0.000 description 1
230000001225 therapeutic effect Effects 0.000 description 1
229960004072 thrombin Drugs 0.000 description 1
238000013518 transcription Methods 0.000 description 1
230000035897 transcription Effects 0.000 description 1
238000013519 translation Methods 0.000 description 1
238000000108 ultra-filtration Methods 0.000 description 1
230000003612 virological effect Effects 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
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/36—Blood coagulation or fibrinolysis factors
- A61K38/37—Factors VIII
- 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

Landscapes

Health & Medical Sciences (AREA)
Life Sciences & Earth Sciences (AREA)
General Health & Medical Sciences (AREA)
Medicinal Chemistry (AREA)
Hematology (AREA)
Chemical & Material Sciences (AREA)
Engineering & Computer Science (AREA)
Bioinformatics & Cheminformatics (AREA)
Public Health (AREA)
Veterinary Medicine (AREA)
Pharmacology & Pharmacy (AREA)
Animal Behavior & Ethology (AREA)
Epidemiology (AREA)
Proteomics, Peptides & Aminoacids (AREA)
Zoology (AREA)
Immunology (AREA)
Gastroenterology & Hepatology (AREA)
Organic Chemistry (AREA)
Chemical Kinetics & Catalysis (AREA)
General Chemical & Material Sciences (AREA)
Diabetes (AREA)
Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Peptides Or Proteins (AREA)
Micro-Organisms Or Cultivation Processes Thereof (AREA)
Preparation Of Compounds By Using Micro-Organisms (AREA)
Medicinal Preparation (AREA)
Medicines Containing Material From Animals Or Micro-Organisms (AREA)

NO20020120A 1999-07-13 2002-01-10 Stabile faktor VIII-sammensetninger NO330048B1 (no)

Applications Claiming Priority (4)

Application Number	Priority Date	Filing Date	Title
SE9902685A SE9902685D0 (sv)	1999-07-13	1999-07-13	Stable protein compositions
US14682899P	1999-08-02	1999-08-02
SE0001743A SE0001743D0 (sv)	2000-05-11	2000-05-11	Stable protein compositions II
PCT/SE2000/001454 WO2001003726A1 (fr)	1999-07-13	2000-07-07	Compositions du facteur viii stable

Publications (3)

Publication Number	Publication Date
NO20020120D0 NO20020120D0 (no)	2002-01-10
NO20020120L NO20020120L (no)	2002-02-28
NO330048B1 true NO330048B1 (no)	2011-02-07

Family

ID=27354553

Family Applications (1)

Application Number	Title	Priority Date	Filing Date
NO20020120A NO330048B1 (no)	1999-07-13	2002-01-10	Stabile faktor VIII-sammensetninger

Country Status (14)

Country	Link
US (1)	US6599724B1 (fr)
EP (1)	EP1194161B1 (fr)
JP (1)	JP4674021B2 (fr)
AR (1)	AR024735A1 (fr)
AT (1)	ATE310533T1 (fr)
AU (1)	AU780415B2 (fr)
CA (1)	CA2378751C (fr)
CY (1)	CY1104986T1 (fr)
DE (1)	DE60024268T2 (fr)
DK (1)	DK1194161T3 (fr)
ES (1)	ES2252028T3 (fr)
NO (1)	NO330048B1 (fr)
NZ (1)	NZ516400A (fr)
WO (1)	WO2001003726A1 (fr)

Families Citing this family (33)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
EP1820516B1 (fr)	1999-02-22	2013-07-24	University of Connecticut	Nouvelles formulations de facteur VIII sans albumine
JP2005530683A (ja)	2001-12-21	2005-10-13	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体組成物
KR20040065278A (ko) *	2001-12-21	2004-07-21	노보 노르디스크 에이/에스	변경된 인자 ⅶ 폴리펩티드의 액체 조성물
GB0202633D0 (en) *	2002-02-05	2002-03-20	Delta Biotechnology Ltd	Stabilization of protein preparations
GB0207092D0 (en) *	2002-03-26	2002-05-08	Sod Conseils Rech Applic	Stable pharmaceutical composition containing factor VIII
US20040009918A1 (en) *	2002-05-03	2004-01-15	Hanne Nedergaard	Stabilised solid compositions of modified factor VII
CN101912601B (zh)	2002-06-21	2012-08-29	诺和诺德医疗保健公司	因子vii多肽的稳定化固体组合物
RU2305323C2 (ru) †	2002-12-27	2007-08-27	Джэпэн Кэш Машин Ко., Лтд.	Оптическое воспринимающее устройство для обнаружения оптических признаков ценных бумаг
CA2518327A1 (fr) *	2003-03-18	2004-09-30	Novo Nordisk Health Care Ag	Compositions pharmaceutiques aqueuses, liquides, des polypeptides du facteur vii
US7897734B2 (en) *	2003-03-26	2011-03-01	Novo Nordisk Healthcare Ag	Method for the production of proteins
KR20060015574A (ko) *	2003-05-23	2006-02-17	노보 노르디스크 헬스 케어 악티엔게젤샤프트	용액 중 단백질 안정화
US7485291B2 (en)	2003-06-03	2009-02-03	Cell Genesys, Inc.	Compositions and methods for generating multiple polypeptides from a single vector using a virus derived peptide cleavage site, and uses thereof
WO2005017149A1 (fr)	2003-06-03	2005-02-24	Cell Genesys, Inc.	Compositions et methodes pour une expression amelioree de polypeptides recombinants a partir d'un vecteur unique, faisant appel a un site de clivage peptidique
ES2382157T3 (es) *	2003-06-25	2012-06-05	Novo Nordisk Health Care Ag	Composición líquida de polipépttidos del factor VII
JP5306597B2 (ja) *	2003-07-01	2013-10-02	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因子ポリペプチドの液体水性薬学的組成物
EP1656158B1 (fr)	2003-08-14	2016-03-09	Novo Nordisk Health Care AG	Composition pharmaceutique liquide aqueuse de polypeptides du facteur vii
ES2229931B1 (es) *	2003-10-03	2006-01-16	Grifols, S.A.	Composicion liquida bilogicamente estable de fviii, de fvw o del complejo fviii/fvw humanos.
US20050090551A1 (en) *	2003-10-27	2005-04-28	Board Of Trustees Of Southern Illinois University	Therapeutic use of methionine for the treatment or prevention of mucositis
ATE463572T1 (de) *	2003-12-03	2010-04-15	Univ Rochester	Rekombinanter faktor viii mit erhöhter spezifischer aktivität
EP2311437A1 (fr) *	2003-12-19	2011-04-20	Novo Nordisk Health Care AG	Compositions stabilisees de polypeptides de facteur VII
US7422875B2 (en)	2004-07-20	2008-09-09	Board Of Regents Of The University Of Nebraska	Compositions and methods for increasing protein production
US20090017007A1 (en) *	2005-08-26	2009-01-15	Maxygen Holdings Ltd.	Liquid factor vii composition
FR2908892B1 (fr) *	2006-11-21	2009-02-20	Hyphen Biomed Soc Par Actions	Procede pour le dosage chromogenique de l'activite du facteur viii:c et necessaire de dosage chromogenique de l'activite du facteur viii:c,dans les plasmas ou les fractions therapeutiques
CA2703948A1 (fr) *	2007-11-01	2009-05-07	University Of Rochester	Facteur viii recombinant ayant une stabilite accrue
SI2574677T1 (sl)	2007-12-27	2017-11-30	Baxalta GmbH	Procesi celične kulture
EP2385825B1 (fr) *	2008-11-07	2018-10-10	University of Connecticut	Formulation de facteur viii
GB0915480D0 (en)	2009-09-04	2009-10-07	Arecor Ltd	Stable formulation of factor viii
GB0915481D0 (en)	2009-09-04	2009-10-07	Arecor Ltd	Stable manufacture of factor V111
BR112013011041B1 (pt)	2010-11-05	2021-05-25	Baxalta GmbH	variante de fator viii, método para produzir uma variante de fviii, uso da variante de fator viii, e, composição farmacêutica
RU2600886C2 (ru) *	2011-05-13	2016-10-27	Октафарма Аг	Способ повышения продуктивности эукариотических клеток в продуцировании рекомбинантного fviii
CN103917554B (zh)	2011-10-18	2017-03-08	杰特有限公司	用于改善重构后纯化的因子viii的稳定性的方法
CN106456720A (zh)	2014-04-01	2017-02-22	爱德技术生物科学有限公司	在无钙作为赋形剂下因子viii的稳定性
US9907835B2 (en)	2014-04-01	2018-03-06	Advanced Bioscience Farmacêutica LTDA	Stable Factor VIII formulations with low sugar-glycine

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
JP2593500B2 (ja)	1986-06-24	1997-03-26	ノルデイスクゲントフテエー／エス	▲ｖｉｉｉ▼因子フラグメントの凝固活性複合物の製造方法
ATE198277T1 (de)	1992-10-02	2001-01-15	Genetics Inst	Zusammensetzung, welche den koagulationsfaktor viii beinhaltet; verfahren zu deren herstellung und die benutzung eines oberflächenaktiven stoffes als stabilisator
SE9301581D0 (sv) *	1993-05-07	1993-05-07	Kabi Pharmacia Ab	Protein formulation
WO1995003332A1 (fr) *	1993-07-23	1995-02-02	Baxter International Inc.	Facteur viii humain active et procede de preparation
US5576291A (en) *	1993-09-13	1996-11-19	Baxter International Inc.	Activated factor VIII as a therapeutic agent and method of treating factor VIII deficiency
DE69737455T2 (de) *	1996-10-11	2007-12-06	Invitrogen Corp., Carlsbad	Definierte systeme zur kultivierung epithelialer zellen und anwendung derselben
US5804420A (en) *	1997-04-18	1998-09-08	Bayer Corporation	Preparation of recombinant Factor VIII in a protein free medium

2000
- 2000-07-07 EP EP00948452A patent/EP1194161B1/fr not_active Expired - Lifetime
- 2000-07-07 WO PCT/SE2000/001454 patent/WO2001003726A1/fr not_active Ceased
- 2000-07-07 JP JP2001509201A patent/JP4674021B2/ja not_active Expired - Lifetime
- 2000-07-07 AU AU61933/00A patent/AU780415B2/en not_active Expired
- 2000-07-07 CA CA2378751A patent/CA2378751C/fr not_active Expired - Lifetime
- 2000-07-07 DE DE60024268T patent/DE60024268T2/de not_active Expired - Lifetime
- 2000-07-07 NZ NZ516400A patent/NZ516400A/xx not_active IP Right Cessation
- 2000-07-07 DK DK00948452T patent/DK1194161T3/da active
- 2000-07-07 AT AT00948452T patent/ATE310533T1/de active
- 2000-07-07 ES ES00948452T patent/ES2252028T3/es not_active Expired - Lifetime
- 2000-07-12 US US09/615,001 patent/US6599724B1/en not_active Expired - Lifetime
- 2000-07-13 AR ARP000103610A patent/AR024735A1/es not_active Application Discontinuation
2002
- 2002-01-10 NO NO20020120A patent/NO330048B1/no not_active IP Right Cessation
2006
- 2006-02-21 CY CY20061100247T patent/CY1104986T1/el unknown

Also Published As

Publication number	Publication date
DK1194161T3 (da)	2006-02-13
AU6193300A (en)	2001-01-30
CY1104986T1 (el)	2009-11-04
WO2001003726A1 (fr)	2001-01-18
JP2003504345A (ja)	2003-02-04
JP4674021B2 (ja)	2011-04-20
EP1194161B1 (fr)	2005-11-23
EP1194161A1 (fr)	2002-04-10
NO20020120L (no)	2002-02-28
NZ516400A (en)	2004-02-27
DE60024268D1 (de)	2005-12-29
ES2252028T3 (es)	2006-05-16
DE60024268T2 (de)	2006-08-03
CA2378751A1 (fr)	2001-01-18
AR024735A1 (es)	2002-10-23
CA2378751C (fr)	2012-11-06
US6599724B1 (en)	2003-07-29
ATE310533T1 (de)	2005-12-15
AU780415B2 (en)	2005-03-17
NO20020120D0 (no)	2002-01-10

Legal Events

Date	Code	Title	Description
2020-08-10	MK1K	Patent expired

Publication	Publication Date	Title
EP1194161B1 (fr)	2005-11-23	Compositions du facteur viii stable
JP7003183B2 (ja)	2022-02-04	凍結乾燥した組換え型ｖｗｆ製剤
US11191837B2 (en)	2021-12-07	Recombinant VWF formulations
JP2012506387A5 (fr)	2015-02-12
CA2301514A1 (fr)	1999-03-04	Preparations deshydratees possedant une activite biologique ou therapeutique
US20220257723A1 (en)	2022-08-18	Lyophilized recombinant vwf formulations
AU2015258348A1 (en)	2015-12-10	Lyophilized Recombinant VWF Formulations
AU8723198A (en)	1999-03-16	Dried biologically or therapeutically active preparations