JP2012530770A5 - - Google Patents
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- Publication number
- JP2012530770A5 JP2012530770A5 JP2012516820A JP2012516820A JP2012530770A5 JP 2012530770 A5 JP2012530770 A5 JP 2012530770A5 JP 2012516820 A JP2012516820 A JP 2012516820A JP 2012516820 A JP2012516820 A JP 2012516820A JP 2012530770 A5 JP2012530770 A5 JP 2012530770A5
- Authority
- JP
- Japan
- Prior art keywords
- arginine
- lysine
- glycine
- amino acids
- hydrochloride
- 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.)
- Granted
Links
- DHMQDGOQFOQNFH-UHFFFAOYSA-N glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 description 12
- 235000001014 amino acid Nutrition 0.000 description 8
- 150000001413 amino acids Chemical class 0.000 description 8
- 239000004471 Glycine Substances 0.000 description 6
- 229940024606 Amino Acids Drugs 0.000 description 5
- 229940021015 I.V. solution additive Amino Acids Drugs 0.000 description 5
- 239000004475 Arginine Substances 0.000 description 4
- 108010054265 Factor VIIa Proteins 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
- 239000004472 Lysine Substances 0.000 description 4
- 229960003121 arginine Drugs 0.000 description 4
- 229960003646 lysine Drugs 0.000 description 4
- 239000000203 mixture Substances 0.000 description 4
- KWTQSFXGGICVPE-WCCKRBBISA-N (2S)-2-amino-5-(diaminomethylideneamino)pentanoic acid;hydron;chloride Chemical compound Cl.OC(=O)[C@@H](N)CCCN=C(N)N KWTQSFXGGICVPE-WCCKRBBISA-N 0.000 description 3
- 102100009906 F7 Human genes 0.000 description 3
- 108010023321 Factor VII Proteins 0.000 description 3
- 229940012414 Factor VIIa Drugs 0.000 description 3
- BVHLGVCQOALMSV-JEDNCBNOSA-N L-lysine hydrochloride Chemical compound Cl.NCCCC[C@H](N)C(O)=O BVHLGVCQOALMSV-JEDNCBNOSA-N 0.000 description 3
- 229940068968 Polysorbate 80 Drugs 0.000 description 3
- 229940012413 factor VII Drugs 0.000 description 3
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 description 3
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 description 3
- 229920000053 polysorbate 80 Polymers 0.000 description 3
- 229940019746 Antifibrinolytic amino acids Drugs 0.000 description 2
- 229960003589 Arginine hydrochloride Drugs 0.000 description 2
- VEXZGXHMUGYJMC-UHFFFAOYSA-N HCl Chemical group Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 2
- 229960000310 ISOLEUCINE Drugs 0.000 description 2
- 229960005337 Lysine Hydrochloride Drugs 0.000 description 2
- 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 2
- UXVMQQNJUSDDNG-UHFFFAOYSA-L cacl2 Chemical compound [Cl-].[Cl-].[Ca+2] UXVMQQNJUSDDNG-UHFFFAOYSA-L 0.000 description 2
- 150000003839 salts Chemical class 0.000 description 2
- 239000011780 sodium chloride Substances 0.000 description 2
- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate dihydrate Chemical compound O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 description 2
- 229940038773 trisodium citrate Drugs 0.000 description 2
- 239000011778 trisodium citrate Substances 0.000 description 2
- 229960001230 Asparagine Drugs 0.000 description 1
- 229940052299 Calcium Chloride Dihydrate Drugs 0.000 description 1
- MTCFGRXMJLQNBG-UWTATZPHSA-N D-serine Chemical compound OC[C@@H](N)C(O)=O MTCFGRXMJLQNBG-UWTATZPHSA-N 0.000 description 1
- ODKSFYDXXFIFQN-BYPYZUCNSA-P L-argininium(2+) Chemical compound NC(=[NH2+])NCCC[C@H]([NH3+])C(O)=O ODKSFYDXXFIFQN-BYPYZUCNSA-P 0.000 description 1
- DCXYFEDJOCDNAF-REOHCLBHSA-N L-asparagine Chemical compound OC(=O)[C@@H](N)CC(N)=O DCXYFEDJOCDNAF-REOHCLBHSA-N 0.000 description 1
- ZDXPYRJPNDTMRX-VKHMYHEASA-N L-glutamine Chemical compound OC(=O)[C@@H](N)CCC(N)=O ZDXPYRJPNDTMRX-VKHMYHEASA-N 0.000 description 1
- HNDVDQJCIGZPNO-YFKPBYRVSA-N L-histidine Chemical compound OC(=O)[C@@H](N)CC1=CN=CN1 HNDVDQJCIGZPNO-YFKPBYRVSA-N 0.000 description 1
- KDXKERNSBIXSRK-YFKPBYRVSA-N L-lysine Chemical compound NCCCC[C@H](N)C(O)=O KDXKERNSBIXSRK-YFKPBYRVSA-N 0.000 description 1
- AYFVYJQAPQTCCC-GBXIJSLDSA-N L-threonine Chemical compound C[C@@H](O)[C@H](N)C(O)=O AYFVYJQAPQTCCC-GBXIJSLDSA-N 0.000 description 1
- OUYCCCASQSFEME-QMMMGPOBSA-N L-tyrosine Chemical compound OC(=O)[C@@H](N)CC1=CC=C(O)C=C1 OUYCCCASQSFEME-QMMMGPOBSA-N 0.000 description 1
- CCTIOCVIZPCTGO-BYPYZUCNSA-M N(ω)-phosphonato-L-arginine Chemical compound [O-]C(=O)[C@@H]([NH3+])CCCNC(=[NH2+])NP([O-])([O-])=O CCTIOCVIZPCTGO-BYPYZUCNSA-M 0.000 description 1
- 229920001213 Polysorbate 20 Polymers 0.000 description 1
- 229940068977 Polysorbate 20 Drugs 0.000 description 1
- 239000012505 Superdex™ Substances 0.000 description 1
- 239000004473 Threonine Substances 0.000 description 1
- 235000009582 asparagine Nutrition 0.000 description 1
- -1 bromobutyl Chemical group 0.000 description 1
- 229920005557 bromobutyl Polymers 0.000 description 1
- UIIMBOGNXHQVGW-UHFFFAOYSA-M buffer Substances [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 description 1
- 239000007853 buffer solution Substances 0.000 description 1
- 229960002713 calcium chloride Drugs 0.000 description 1
- 239000001110 calcium chloride Substances 0.000 description 1
- 229910001628 calcium chloride Inorganic materials 0.000 description 1
- 238000002523 gelfiltration Methods 0.000 description 1
- 230000002209 hydrophobic Effects 0.000 description 1
- 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 description 1
- 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
Description
本発明組成物は、少なくとも1の親水性アミノ酸または正に荷電した側鎖を有するアミノ酸を含み、所望により少なくとも1の疎水性アミノ酸も含む。親水性(または極性)アミノ酸または正に荷電した側鎖を有するアミノ酸には、リジン、アルギニン、ヒスチジン、グリシン、セリン、トレオニン、チロシン、アスパラギン、およびグルタミンが含まれる。親水性アミノ酸または正に荷電した側鎖を有するアミノ酸のうち、アルギニン、またはその塩の一つ、例えば、アルギニン塩酸塩、またはアルギニンリン酸塩を選択的に用いることができる。アミノ酸、例えばグリシンおよび/またはリジン、またはその塩、例えばリジン塩酸塩を好都合に加えることができる。
ある実施例において、該組成物は、以下のものを含む：
好ましくは第VIIa因子形の第VII因子；
所望により塩酸形のアルギニン；
イソロイシン；
リジン；
グリシン；
クエン酸三ナトリウムまたは塩化カルシウム；および
適切であれば、ポリソルベート80またはポリソルベート20。
好ましくは第VIIa因子形の第VII因子；
所望により塩酸形のアルギニン；
イソロイシン；
リジン；
グリシン；
クエン酸三ナトリウムまたは塩化カルシウム；および
適切であれば、ポリソルベート80またはポリソルベート20。
より詳細には、該組成物は以下のものを含む：
好ましくは第VIIa因子形の第VII因子；
10〜40g/lの所望により塩酸形のアルギニン；
4.2〜6.6g/lのイソロイシン；
0.6〜1.8g/lのリジン；
0.6〜1.8g/lのグリシン；
1〜2g/lのクエン酸三ナトリウム二水和物または0〜0.2g/lの塩化カルシウム二水和物；および
適切であれば、0〜0.5g/lのポリソルベート80。
好ましくは第VIIa因子形の第VII因子；
10〜40g/lの所望により塩酸形のアルギニン；
4.2〜6.6g/lのイソロイシン；
0.6〜1.8g/lのリジン；
0.6〜1.8g/lのグリシン；
1〜2g/lのクエン酸三ナトリウム二水和物または0〜0.2g/lの塩化カルシウム二水和物；および
適切であれば、0〜0.5g/lのポリソルベート80。
ある例では、該組成物は、以下のものを含む：
第VII因子(好ましくは第VIIa因子の形の)を0.2〜2g/l、
アルギニン塩酸塩を24g/l、
イソロイシンを6g/l、
クエン酸三ナトリウム二水和物を1.5g/l、
グリシンを1.2g/l、
リジン塩酸塩を1.2g/l、および/または
ポリソルベート80を0.07g/l。
第VII因子(好ましくは第VIIa因子の形の)を0.2〜2g/l、
アルギニン塩酸塩を24g/l、
イソロイシンを6g/l、
クエン酸三ナトリウム二水和物を1.5g/l、
グリシンを1.2g/l、
リジン塩酸塩を1.2g/l、および/または
ポリソルベート80を0.07g/l。
精製し、活性化した第VII因子(約0.4mg/ml)を、Superdex 200ゲルろ過カラムで緩衝液交換により製剤化した。最初に、カラムを、クエン酸三ナトリウム(1.0g/l)、アルギニン塩酸塩(30g/l)、およびイソロイシン(6.0g/l)を含む緩衝溶液で平衡化した(表：F9参照)。pH(7.0±0.2)を調整した。グリシン(1.2 mg/ml)およびリジン塩酸塩(1.2mg/ml)を加えた。製剤化したFVIIa溶液をろ過し、ボトルに1.0mL/ボトルの割合で分配した。次に、ボトルをブロモブチル栓で予備的に栓をした。次に、ボトルを先に記載のごとく凍結乾燥し、次いで40℃で6月間保存した。
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| FR0954390 | 2009-06-26 | ||
| FR0954390A FR2947181B1 (fr) | 2009-06-26 | 2009-06-26 | Composition de facteur vii |
| PCT/FR2010/051229 WO2010149907A1 (fr) | 2009-06-26 | 2010-06-18 | Composition de facteur vii |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2015038948A Division JP2015134795A (ja) | 2009-06-26 | 2015-02-27 | 第ｖｉｉ因子組成物 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2012530770A JP2012530770A (ja) | 2012-12-06 |
| JP2012530770A5 true JP2012530770A5 (ja) | 2014-03-20 |
| JP5706888B2 JP5706888B2 (ja) | 2015-04-22 |
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 After (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| 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 |
Country Status (17)
| Country | Link |
|---|---|
| US (3) | US9029316B2 (ja) |
| EP (2) | EP2985033B3 (ja) |
| JP (3) | JP5706888B2 (ja) |
| KR (1) | KR101468115B1 (ja) |
| CN (2) | CN102458455B (ja) |
| AR (1) | AR077234A1 (ja) |
| AU (1) | AU2010264369B2 (ja) |
| BR (1) | BRPI1010707A2 (ja) |
| CA (1) | CA2764779C (ja) |
| DK (2) | DK2985033T6 (ja) |
| ES (2) | ES2725449T7 (ja) |
| FR (2) | FR2947181B1 (ja) |
| IL (1) | IL216872A (ja) |
| NL (1) | NL301213I2 (ja) |
| PL (2) | PL2985033T3 (ja) |
| TR (1) | TR201906145T4 (ja) |
| WO (1) | WO2010149907A1 (ja) |
Families Citing this family (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP1711513B1 (en) | 2003-12-01 | 2014-07-02 | 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 |
| CN103429272A (zh) | 2010-12-30 | 2013-12-04 | 法国化学与生物科技实验室 | 作为病原体灭活剂的二元醇 |
| 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 |
| BR112019000610A2 (pt) * | 2016-07-11 | 2019-07-02 | Opko Biologics Ltd | fator vii de coagulação de longa ação e métodos de produção do mesmo |
| 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 |
| CN117860874A (zh) * | 2024-03-12 | 2024-04-12 | 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 |
| 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 |
| AU6558400A (en) * | 1999-08-17 | 2001-03-13 | Novo Nordisk A/S | Stabilisation of freeze-dried cake |
| DE60143292D1 (de) * | 2000-05-03 | 2010-12-02 | Novo Nordisk Healthcare Ag | Varianten des menschlichen Koagulationsfaktors VII |
| JP2005526004A (ja) * | 2001-11-09 | 2005-09-02 | ノボ ノルディスク ヘルス ケア アクチェンゲゼルシャフト | 第ｖｉｉ因子ポリペプチドおよびトラネキサム酸を含む薬学的組成物 |
| PL207018B1 (pl) | 2002-06-21 | 2010-10-29 | Novo Nordisk Helth Care Ag | Kompozycja farmaceutyczna, sposób przygotowania stabilnego polipeptydu czynnika VII i zastosowanie polipeptydu czynnika VII |
| NZ573412A (en) * | 2003-06-19 | 2010-09-30 | Maxygen Holdings Ltd | Factor VII or VIIa Gla domain variants |
| FR2857267B1 (fr) | 2003-07-09 | 2006-03-10 | Lab Francais Du Fractionnement | Formulation stabilisante et solubilisante pour les proteines cryoprecipitables. |
| ES2574581T3 (es) * | 2003-08-14 | 2016-06-20 | Novo Nordisk Health Care Ag | Composición farmacéutica líquida acuosa de polipéptidos de tipo Factor VII |
| EP1855722A2 (en) * | 2005-02-24 | 2007-11-21 | Novo Nordisk Health Care AG | Compounds for stabilizing factor vii polypeptide formulations |
| US8703706B2 (en) * | 2005-04-28 | 2014-04-22 | Novo Nordisk Healthcare Ag | Closed container comprising an activated factor VII polypeptide, processes for the preparation of the same, and a kit and a method for use of the kit |
| WO2007022784A2 (en) * | 2005-08-26 | 2007-03-01 | 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. |
| EP2114379A2 (en) * | 2006-12-20 | 2009-11-11 | Bayer HealthCare LLC | Factor vii and viia compositions |
| FR2910786B1 (fr) | 2006-12-29 | 2017-08-11 | Laboratoire Francais Du Fractionnement Et Des Biotechnologies (Lfb) | "procede d'extraction d'une proteine presente dans du lait" |
| EP2129686B1 (en) * | 2007-03-20 | 2016-07-13 | CSL Behring GmbH | Methods for industrial scale production of therapeutic complement factor h preparations from human plasma |
| WO2008135500A1 (en) * | 2007-05-02 | 2008-11-13 | Novo Nordisk Health Care Ag | High concentration factor vii polypeptide formulations comprising an aromatic preservative and an antioxidant |
| FR2947181B1 (fr) * | 2009-06-26 | 2012-05-04 | Lfb Biotechnologies | Composition de facteur vii |
-
2009
- 2009-06-26 FR FR0954390A patent/FR2947181B1/fr active Active
-
2010
- 2010-06-18 US US13/377,680 patent/US9029316B2/en active Active
- 2010-06-18 BR BRPI1010707A patent/BRPI1010707A2/pt not_active Application Discontinuation
- 2010-06-18 PL PL15175122T patent/PL2985033T3/pl unknown
- 2010-06-18 CA CA2764779A patent/CA2764779C/fr active Active
- 2010-06-18 KR KR1020127002102A patent/KR101468115B1/ko active IP Right Grant
- 2010-06-18 DK DK15175122.9T patent/DK2985033T6/da active
- 2010-06-18 WO PCT/FR2010/051229 patent/WO2010149907A1/fr active Application Filing
- 2010-06-18 EP EP15175122.9A patent/EP2985033B3/fr active Active
- 2010-06-18 AU AU2010264369A patent/AU2010264369B2/en not_active Ceased
- 2010-06-18 TR TR2019/06145T patent/TR201906145T4/tr unknown
- 2010-06-18 CN CN201080028582.4A patent/CN102458455B/zh active Active
- 2010-06-18 PL PL10734272T patent/PL2445516T3/pl unknown
- 2010-06-18 EP EP10734272.7A patent/EP2445516B1/fr active Active
- 2010-06-18 DK DK10734272.7T patent/DK2445516T3/en active
- 2010-06-18 JP JP2012516820A patent/JP5706888B2/ja not_active Expired - Fee Related
- 2010-06-18 ES ES15175122T patent/ES2725449T7/es active Active
- 2010-06-18 CN CN201510137928.9A patent/CN105106943A/zh active Pending
- 2010-06-18 ES ES10734272.7T patent/ES2550269T3/es 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/FR23C1001I1/fr active Active
- 2023-01-16 NL NL301213C patent/NL301213I2/nl unknown
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