JP2015134795A5 - - Google Patents
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- Publication number
- JP2015134795A5 JP2015134795A5 JP2015038948A JP2015038948A JP2015134795A5 JP 2015134795 A5 JP2015134795 A5 JP 2015134795A5 JP 2015038948 A JP2015038948 A JP 2015038948A JP 2015038948 A JP2015038948 A JP 2015038948A JP 2015134795 A5 JP2015134795 A5 JP 2015134795A5
- Authority
- JP
- Japan
- Prior art keywords
- composition according
- factor vii
- pharmaceutical composition
- composition
- isoleucine
- 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.)
- Pending
Links
- 239000000203 mixture Substances 0.000 claims 9
- 102100023804 Coagulation factor VII Human genes 0.000 claims 7
- 108010023321 Factor VII Proteins 0.000 claims 7
- 229940012413 factor vii Drugs 0.000 claims 7
- 239000008194 pharmaceutical composition Substances 0.000 claims 7
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 claims 4
- AGPKZVBTJJNPAG-WHFBIAKZSA-N L-isoleucine Chemical compound CC[C@H](C)[C@H](N)C(O)=O AGPKZVBTJJNPAG-WHFBIAKZSA-N 0.000 claims 4
- 239000004615 ingredient Substances 0.000 claims 4
- -1 alkali metal salt Chemical class 0.000 claims 3
- 238000002360 preparation method Methods 0.000 claims 3
- KWTQSFXGGICVPE-UHFFFAOYSA-N 2-amino-5-(diaminomethylideneamino)pentanoic acid;hydron;chloride Chemical compound Cl.OC(=O)C(N)CCCN=C(N)N KWTQSFXGGICVPE-UHFFFAOYSA-N 0.000 claims 2
- 239000004475 Arginine Substances 0.000 claims 2
- 239000004472 Lysine Substances 0.000 claims 2
- KDXKERNSBIXSRK-UHFFFAOYSA-N Lysine Natural products NCCCCC(N)C(O)=O KDXKERNSBIXSRK-UHFFFAOYSA-N 0.000 claims 2
- 229940024606 amino acid Drugs 0.000 claims 2
- 235000001014 amino acid Nutrition 0.000 claims 2
- 150000001413 amino acids Chemical class 0.000 claims 2
- 229960003121 arginine Drugs 0.000 claims 2
- ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 0.000 claims 2
- LLSDKQJKOVVTOJ-UHFFFAOYSA-L calcium chloride dihydrate Chemical compound O.O.[Cl-].[Cl-].[Ca+2] LLSDKQJKOVVTOJ-UHFFFAOYSA-L 0.000 claims 2
- 229940052299 calcium chloride dihydrate Drugs 0.000 claims 2
- YMAWOPBAYDPSLA-UHFFFAOYSA-N glycylglycine Chemical compound [NH3+]CC(=O)NCC([O-])=O YMAWOPBAYDPSLA-UHFFFAOYSA-N 0.000 claims 2
- 239000007788 liquid Substances 0.000 claims 2
- 229960003646 lysine Drugs 0.000 claims 2
- 238000004519 manufacturing process Methods 0.000 claims 2
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 claims 2
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims 2
- 229920000053 polysorbate 80 Polymers 0.000 claims 2
- 229940068968 polysorbate 80 Drugs 0.000 claims 2
- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical compound O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 claims 2
- 239000007787 solid Substances 0.000 claims 2
- 239000008247 solid mixture Substances 0.000 claims 2
- UXVMQQNJUSDDNG-UHFFFAOYSA-L Calcium chloride Chemical compound [Cl-].[Cl-].[Ca+2] UXVMQQNJUSDDNG-UHFFFAOYSA-L 0.000 claims 1
- 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 claims 1
- 239000004471 Glycine Substances 0.000 claims 1
- 108010008488 Glycylglycine Proteins 0.000 claims 1
- 208000031220 Hemophilia Diseases 0.000 claims 1
- 208000009292 Hemophilia A Diseases 0.000 claims 1
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical group Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims 1
- BVHLGVCQOALMSV-JEDNCBNOSA-N L-lysine hydrochloride Chemical compound Cl.NCCCC[C@H](N)C(O)=O BVHLGVCQOALMSV-JEDNCBNOSA-N 0.000 claims 1
- 229930195725 Mannitol Natural products 0.000 claims 1
- 229920001213 Polysorbate 20 Polymers 0.000 claims 1
- 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 claims 1
- 229930006000 Sucrose Natural products 0.000 claims 1
- 229910052783 alkali metal Inorganic materials 0.000 claims 1
- 229910052784 alkaline earth metal Inorganic materials 0.000 claims 1
- 239000007853 buffer solution Substances 0.000 claims 1
- 239000001110 calcium chloride Substances 0.000 claims 1
- 229960002713 calcium chloride Drugs 0.000 claims 1
- 229910001628 calcium chloride Inorganic materials 0.000 claims 1
- 208000019060 congenital factor VII deficiency Diseases 0.000 claims 1
- 238000001035 drying Methods 0.000 claims 1
- 238000001914 filtration Methods 0.000 claims 1
- 229960002449 glycine Drugs 0.000 claims 1
- 229940043257 glycylglycine Drugs 0.000 claims 1
- 230000002209 hydrophobic effect Effects 0.000 claims 1
- 229960000310 isoleucine Drugs 0.000 claims 1
- AGPKZVBTJJNPAG-UHFFFAOYSA-N isoleucine Natural products CCC(C)C(N)C(O)=O AGPKZVBTJJNPAG-UHFFFAOYSA-N 0.000 claims 1
- 239000000594 mannitol Substances 0.000 claims 1
- 235000010355 mannitol Nutrition 0.000 claims 1
- 235000006109 methionine Nutrition 0.000 claims 1
- 150000002742 methionines Chemical class 0.000 claims 1
- 238000000034 method Methods 0.000 claims 1
- 238000002156 mixing Methods 0.000 claims 1
- 229920005862 polyol Polymers 0.000 claims 1
- 150000003077 polyols Chemical class 0.000 claims 1
- 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 claims 1
- 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 claims 1
- 229940068977 polysorbate 20 Drugs 0.000 claims 1
- 239000001509 sodium citrate Substances 0.000 claims 1
- 239000005720 sucrose Substances 0.000 claims 1
- 235000000346 sugar Nutrition 0.000 claims 1
- 150000008163 sugars Chemical class 0.000 claims 1
- 238000002560 therapeutic procedure Methods 0.000 claims 1
- 230000009261 transgenic effect Effects 0.000 claims 1
- 229910052723 transition metal Inorganic materials 0.000 claims 1
- 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 claims 1
- 229940038773 trisodium citrate Drugs 0.000 claims 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 1
- 239000008215 water for injection Substances 0.000 claims 1
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| FR0954390A FR2947181B1 (fr) | 2009-06-26 | 2009-06-26 | Composition de facteur vii |
| FR0954390 | 2009-06-26 |
Related Parent Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2012516820A Division JP5706888B2 (ja) | 2009-06-26 | 2010-06-18 | 第ｖｉｉ因子組成物 |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2017001018A Division JP2017081978A (ja) | 2009-06-26 | 2017-01-06 | 第ｖｉｉ因子組成物 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JP2015134795A JP2015134795A (ja) | 2015-07-27 |
| JP2015134795A5 true JP2015134795A5 (enExample) | 2015-09-17 |
Family
ID=41620211
Family Applications (3)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2012516820A Expired - Fee Related JP5706888B2 (ja) | 2009-06-26 | 2010-06-18 | 第ｖｉｉ因子組成物 |
| JP2015038948A Pending JP2015134795A (ja) | 2009-06-26 | 2015-02-27 | 第ｖｉｉ因子組成物 |
| JP2017001018A Pending JP2017081978A (ja) | 2009-06-26 | 2017-01-06 | 第ｖｉｉ因子組成物 |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2012516820A Expired - Fee Related JP5706888B2 (ja) | 2009-06-26 | 2010-06-18 | 第ｖｉｉ因子組成物 |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2017001018A Pending JP2017081978A (ja) | 2009-06-26 | 2017-01-06 | 第ｖｉｉ因子組成物 |
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 |
|---|---|---|---|---|
| AU2004294403A1 (en) | 2003-12-01 | 2005-06-16 | Novo Nordisk Health Care Ag | Nanofiltration of factor VII solutions to remove virus |
| 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 |
| AU2011350895B2 (en) | 2010-12-30 | 2015-05-28 | Laboratoire Francais Du Fractionnement Et Des 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 |
| US20180169297A1 (en) | 2015-06-12 | 2018-06-21 | Laboratoire Français 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 |
| EP4303228B1 (en) | 2016-07-11 | 2026-05-27 | 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 |
Family Cites Families (20)
| 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 |
| DE3751873T2 (de) | 1986-04-09 | 1997-02-13 | 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 |
| ATE264340T1 (de) * | 1999-08-17 | 2004-04-15 | Novo Nordisk Healthcare Ag | Stabilisierung von gefriergetrocknetem kuchen |
| WO2001083725A1 (en) * | 2000-05-03 | 2001-11-08 | Novo Nordisk A/S | Human coagulation factor vii variants |
| 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 |
| 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 |
| JP4915918B2 (ja) * | 2003-06-19 | 2012-04-11 | バイエル ヘルスケア エルエルシー | 第ＶＩＩ因子または第ＶＩＩａ因子のＧｌａドメイン変種 |
| FR2857267B1 (fr) * | 2003-07-09 | 2006-03-10 | Lab Francais Du Fractionnement | Formulation stabilisante et solubilisante pour les proteines cryoprecipitables. |
| EP1656158B1 (en) * | 2003-08-14 | 2016-03-09 | Novo Nordisk Health Care AG | Liquid, aqueous pharmaceutical composition of factor vii polypeptides |
| US20090041747A1 (en) * | 2005-02-24 | 2009-02-12 | Novo Nordisk Health Care Ag | Compounds for Stabilizing Factor VII Polypeptide Formulations |
| JP2008539208A (ja) * | 2005-04-28 | 2008-11-13 | 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 | 活性化型のｖｉｉ因子ポリペプチドを含んでいる閉鎖容器、調製する方法、並びにキットおよび前記キットを使用する方法 |
| 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. |
| 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" |
| ES2595059T3 (es) * | 2007-03-20 | 2016-12-27 | Csl Behring Gmbh | Métodos para la producción a escala industrial de preparados terapéuticos del Factor H del complemento a partir de plasma humano |
| CN101674805A (zh) * | 2007-05-02 | 2010-03-17 | 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 |
-
2009
- 2009-06-26 FR FR0954390A patent/FR2947181B1/fr active Active
-
2010
- 2010-06-18 EP EP10734272.7A patent/EP2445516B1/fr active Active
- 2010-06-18 KR KR1020127002102A patent/KR101468115B1/ko not_active Expired - Fee Related
- 2010-06-18 CN CN201510137928.9A patent/CN105106943A/zh active Pending
- 2010-06-18 TR TR2019/06145T patent/TR201906145T4/tr unknown
- 2010-06-18 DK DK15175122.9T patent/DK2985033T6/da active
- 2010-06-18 WO PCT/FR2010/051229 patent/WO2010149907A1/fr not_active Ceased
- 2010-06-18 PL PL15175122T patent/PL2985033T3/pl unknown
- 2010-06-18 AU AU2010264369A patent/AU2010264369B2/en not_active Ceased
- 2010-06-18 ES ES10734272.7T patent/ES2550269T3/es active Active
- 2010-06-18 ES ES15175122T patent/ES2725449T7/es active Active
- 2010-06-18 US US13/377,680 patent/US9029316B2/en active Active
- 2010-06-18 PL PL10734272T patent/PL2445516T3/pl unknown
- 2010-06-18 JP JP2012516820A patent/JP5706888B2/ja not_active Expired - Fee Related
- 2010-06-18 EP EP15175122.9A patent/EP2985033B3/fr active Active
- 2010-06-18 BR BRPI1010707A patent/BRPI1010707A2/pt not_active Application Discontinuation
- 2010-06-18 CA CA2764779A patent/CA2764779C/fr active Active
- 2010-06-18 DK DK10734272.7T patent/DK2445516T3/en active
- 2010-06-18 CN CN201080028582.4A patent/CN102458455B/zh active Active
- 2010-06-25 AR ARP100102255A patent/AR077234A1/es not_active Application Discontinuation
-
2011
- 2011-12-08 IL IL216872A patent/IL216872A/en not_active IP Right Cessation
-
2015
- 2015-02-27 JP JP2015038948A patent/JP2015134795A/ja active Pending
- 2015-04-15 US US14/687,499 patent/US9358275B2/en active Active
-
2016
- 2016-05-26 US US15/165,786 patent/US9968662B2/en active Active
-
2017
- 2017-01-06 JP JP2017001018A patent/JP2017081978A/ja active Pending
-
2023
- 2023-01-10 FR FR23C1001C patent/FR23C1001I2/fr active Active
- 2023-01-16 NL NL301213C patent/NL301213I2/nl unknown
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