JP2014531910A5 - - Google Patents
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- Publication number
- JP2014531910A5 JP2014531910A5 JP2014536237A JP2014536237A JP2014531910A5 JP 2014531910 A5 JP2014531910 A5 JP 2014531910A5 JP 2014536237 A JP2014536237 A JP 2014536237A JP 2014536237 A JP2014536237 A JP 2014536237A JP 2014531910 A5 JP2014531910 A5 JP 2014531910A5
- Authority
- JP
- Japan
- Prior art keywords
- amino acid
- factor viii
- fused
- amino acids
- molecule
- 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.)
- Withdrawn
Links
- 150000001413 amino acids Chemical class 0.000 claims 45
- 108010054218 Factor VIII Proteins 0.000 claims 36
- 102000001690 Factor VIII Human genes 0.000 claims 36
- 229960000301 factor viii Drugs 0.000 claims 36
- 238000000034 method Methods 0.000 claims 15
- 101000911390 Homo sapiens Coagulation factor VIII Proteins 0.000 claims 11
- 102100026735 Coagulation factor VIII Human genes 0.000 claims 10
- 238000001990 intravenous administration Methods 0.000 claims 7
- 230000006337 proteolytic cleavage Effects 0.000 claims 7
- 201000003542 Factor VIII deficiency Diseases 0.000 claims 5
- 208000009292 Hemophilia A Diseases 0.000 claims 5
- 230000000694 effects Effects 0.000 claims 5
- 238000011534 incubation Methods 0.000 claims 5
- 101100145421 Prochlorococcus marinus (strain SARG / CCMP1375 / SS120) rpoB gene Proteins 0.000 claims 4
- 230000002779 inactivation Effects 0.000 claims 4
- 230000002265 prevention Effects 0.000 claims 4
- 208000031169 hemorrhagic disease Diseases 0.000 claims 3
- 102000057593 human F8 Human genes 0.000 claims 3
- 229960000900 human factor viii Drugs 0.000 claims 3
- 241000699670 Mus sp. Species 0.000 claims 2
- 108090000190 Thrombin Proteins 0.000 claims 2
- 239000007864 aqueous solution Substances 0.000 claims 2
- 238000003556 assay Methods 0.000 claims 2
- 239000012634 fragment Substances 0.000 claims 2
- 238000010253 intravenous injection Methods 0.000 claims 2
- 108020004707 nucleic acids Proteins 0.000 claims 2
- 150000007523 nucleic acids Chemical class 0.000 claims 2
- 102000039446 nucleic acids Human genes 0.000 claims 2
- 239000008194 pharmaceutical composition Substances 0.000 claims 2
- 239000000825 pharmaceutical preparation Substances 0.000 claims 2
- 239000003186 pharmaceutical solution Substances 0.000 claims 2
- 229960004072 thrombin Drugs 0.000 claims 2
- 238000012032 thrombin generation assay Methods 0.000 claims 2
- 108010089996 B-domain-deleted factor VIII Proteins 0.000 claims 1
- 102000002110 C2 domains Human genes 0.000 claims 1
- 108050009459 C2 domains Proteins 0.000 claims 1
- 125000003275 alpha amino acid group Chemical group 0.000 claims 1
- 239000008280 blood Substances 0.000 claims 1
- 210000004369 blood Anatomy 0.000 claims 1
- 239000006143 cell culture medium Substances 0.000 claims 1
- 238000003776 cleavage reaction Methods 0.000 claims 1
- 238000012258 culturing Methods 0.000 claims 1
- 238000004108 freeze drying Methods 0.000 claims 1
- 230000002439 hemostatic effect Effects 0.000 claims 1
- 238000000338 in vitro Methods 0.000 claims 1
- 230000000415 inactivating effect Effects 0.000 claims 1
- 238000002347 injection Methods 0.000 claims 1
- 239000007924 injection Substances 0.000 claims 1
- 238000007918 intramuscular administration Methods 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 108090000765 processed proteins & peptides Proteins 0.000 claims 1
- 238000000746 purification Methods 0.000 claims 1
- 230000000717 retained effect Effects 0.000 claims 1
- 230000007017 scission Effects 0.000 claims 1
- 125000006850 spacer group Chemical group 0.000 claims 1
- 238000003860 storage Methods 0.000 claims 1
- 238000007920 subcutaneous administration Methods 0.000 claims 1
- 230000001131 transforming effect Effects 0.000 claims 1
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201161548601P | 2011-10-18 | 2011-10-18 | |
| US61/548,601 | 2011-10-18 | ||
| EP11185651.4 | 2011-10-18 | ||
| EP11185651 | 2011-10-18 | ||
| PCT/EP2012/070701 WO2013057219A1 (en) | 2011-10-18 | 2012-10-18 | Method for improving the stability of purified factor viii after reconstitution |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2017027545A Division JP2017114889A (ja) | 2011-10-18 | 2017-02-17 | 再構成後の精製第ｖｉｉｉ因子の安定性を改善するための方法 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JP2014531910A JP2014531910A (ja) | 2014-12-04 |
| JP2014531910A5 true JP2014531910A5 (https=) | 2015-11-26 |
Family
ID=48140377
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2014536237A Withdrawn JP2014531910A (ja) | 2011-10-18 | 2012-10-18 | 再構成後の精製第ｖｉｉｉ因子の安定性を改善するための方法 |
| JP2017027545A Pending JP2017114889A (ja) | 2011-10-18 | 2017-02-17 | 再構成後の精製第ｖｉｉｉ因子の安定性を改善するための方法 |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2017027545A Pending JP2017114889A (ja) | 2011-10-18 | 2017-02-17 | 再構成後の精製第ｖｉｉｉ因子の安定性を改善するための方法 |
Country Status (9)
| Country | Link |
|---|---|
| US (5) | US9394353B2 (https=) |
| EP (1) | EP2768853A1 (https=) |
| JP (2) | JP2014531910A (https=) |
| KR (1) | KR20140084208A (https=) |
| CN (1) | CN103917554B (https=) |
| AU (1) | AU2012318292B2 (https=) |
| CA (1) | CA2850579A1 (https=) |
| HK (1) | HK1198541A1 (https=) |
| WO (1) | WO2013057219A1 (https=) |
Families Citing this family (20)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR20140084208A (ko) | 2011-10-18 | 2014-07-04 | 시에스엘 리미티드 | 정제된 인자 ｖｉｉｉ의 재구성 후의 안정성을 향상시키는 방법 |
| EP4122487A1 (en) * | 2013-03-15 | 2023-01-25 | Bioverativ Therapeutics Inc. | Factor viii polypeptide formulations |
| US9855319B2 (en) * | 2014-04-01 | 2018-01-02 | Advantech Bioscience Farmacêutica Ltda | Stabilization of factor VIII without calcium as an excipient |
| JP2017509659A (ja) * | 2014-04-01 | 2017-04-06 | アドヴァンテック・バイオサイエンス・ファルマスーティカ・リミターダ | 低糖−低グリシンの安定な第ｖｉｉｉ因子製剤 |
| EP3193911B1 (en) * | 2014-07-25 | 2023-09-06 | CSL Behring GmbH | Improved factor viii preparations for use in treating hemophilia a |
| CN106687126B (zh) * | 2014-08-04 | 2020-07-28 | 杰特有限公司 | 因子viii制剂 |
| JP7235511B2 (ja) * | 2016-06-24 | 2023-03-08 | モガム・インスティテュート・フォー・バイオメディカル・リサーチ | 組換え型一本鎖ｆｖｉｉｉおよびその化学コンジュゲート |
| WO2017222337A1 (ko) * | 2016-06-24 | 2017-12-28 | 재단법인 목암생명과학연구소 | Fviii 및 vwf 인자를 포함하는 키메라 단백질 및 그 용도 |
| MX2019006444A (es) | 2016-12-02 | 2019-10-30 | Bioverativ Therapeutics Inc | Métodos de tratamiento de artropatía hemofílica utilizando factores de coagulación quiméricos. |
| EP3687580A1 (en) | 2017-09-27 | 2020-08-05 | Sigilon Therapeutics, Inc. | Methods, compositions, and implantable elements comprising active cells |
| JP7110360B2 (ja) | 2017-10-09 | 2022-08-01 | テルモ ビーシーティー バイオテクノロジーズ，エルエルシー | 凍結乾燥方法 |
| US20210145889A1 (en) | 2018-04-04 | 2021-05-20 | Sigilon Therapeutics, Inc. | Methods, compositions, and implantable elements comprising stem cells |
| BR112020020084A2 (pt) | 2018-04-04 | 2021-01-05 | Sigilon Therapeutics, Inc. | Partícula, preparação de uma pluralidade de partículas, método de preparação de uma partícula, e, composição de partículas. |
| MX2020012103A (es) * | 2018-05-18 | 2021-01-29 | Zhengzhou Gensciences Inc | Proteina de fusion fviii mejorada y uso de la misma. |
| PL3793588T3 (pl) | 2018-05-18 | 2025-09-01 | Bioverativ Therapeutics Inc. | Sposoby leczenia hemofilii a |
| UY38389A (es) | 2018-09-27 | 2020-04-30 | Sigilon Therapeutics Inc | Dispositivos implantables para terapia celular y métodos relacionados |
| CN113597532B (zh) | 2019-03-14 | 2023-02-17 | 泰尔茂比司特生物技术有限公司 | 冻干容器填充固定装置、系统及使用方法 |
| EP3736286A1 (en) | 2019-05-09 | 2020-11-11 | Biotest AG | Single chain factor viii molecule |
| WO2024081309A1 (en) | 2022-10-11 | 2024-04-18 | Sigilon Therapeutics, Inc. | Engineered cells and implantable elements for treatment of disease |
| JP2025534667A (ja) | 2022-10-11 | 2025-10-17 | シギロン セラピューティクス， インコーポレイテッド | 疾患治療のための改変細胞及び移植可能エレメント |
Family Cites Families (30)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4757006A (en) | 1983-10-28 | 1988-07-12 | Genetics Institute, Inc. | Human factor VIII:C gene and recombinant methods for production |
| ES8801674A1 (es) | 1985-04-12 | 1988-02-16 | Genetics Inst | Un procedimiento para la preparacion de una proteina que presenta actividad procoagulante. |
| KR910006424B1 (ko) | 1985-08-21 | 1991-08-24 | 인코텍스 비.브이 | 편성브리프(brief) 제조방법 |
| US5451521A (en) * | 1986-05-29 | 1995-09-19 | Genetics Institute, Inc. | Procoagulant proteins |
| US5422260A (en) * | 1986-05-29 | 1995-06-06 | Genetics Institute, Inc. -Legal Affairs | Human factor VIII:c muteins |
| IL84168A0 (en) | 1986-10-15 | 1988-03-31 | Rorer Int Overseas | Human factor viii-c analogs,process for the preparation thereof and pharmaceutical compositions containing the same |
| JP2872255B2 (ja) | 1987-01-30 | 1999-03-17 | バイオジエン，インコーポレイティド | ファクター▲ｖｉｉｉ▼の高収量生産法 |
| EP0294910B1 (en) | 1987-06-12 | 1996-09-11 | Immuno Ag | Novel proteins with factor VIII activity, process for their preparation using genetically engineered cells and pharmaceutical compositions containing them |
| IL86693A (en) | 1987-06-12 | 1994-06-24 | Stichting Centraal Lab | Proteins with factor VIII activity, process for their preparation using genetically engineered cells and pharmaceutical compositions containing them |
| DE3720246A1 (de) | 1987-06-19 | 1988-12-29 | Behringwerke Ag | Faktor viii:c-aehnliches molekuel mit koagulationsaktivitaet |
| FR2619314B1 (fr) | 1987-08-11 | 1990-06-15 | Transgene Sa | Analogue du facteur viii, procede de preparation et composition pharmaceutique le contenant |
| US5605884A (en) | 1987-10-29 | 1997-02-25 | Rhone-Poulenc Rorer Pharmaceuticals Inc. | Factor VIII formulations in high ionic strength media |
| US5661008A (en) | 1991-03-15 | 1997-08-26 | Kabi Pharmacia Ab | Recombinant human factor VIII derivatives |
| DE4111393A1 (de) | 1991-04-09 | 1992-10-15 | Behringwerke Ag | Stabilisierte faktor viii-praeparationen |
| AT403764B (de) | 1996-03-15 | 1998-05-25 | Immuno Ag | Stabiler faktor viii/vwf-komplex |
| WO1997040145A1 (en) | 1996-04-24 | 1997-10-30 | The Regents Of The University Of Michigan | Inactivation resistant factor viii |
| WO2000024759A1 (en) | 1998-10-23 | 2000-05-04 | The Trustees Of The University Of Pennsylvania | Systemic delivery of gene products via skin |
| DE60024268T2 (de) | 1999-07-13 | 2006-08-03 | Biovitrum Ab | Zusammensetzungen mit stabilem faktor viii |
| EE200200538A (et) | 2000-03-22 | 2004-04-15 | Octagene Gmbh | Rekombinantsete verehüübimisfaktorite produtseerimine inimese rakuliinides |
| WO2002098454A2 (en) * | 2001-05-31 | 2002-12-12 | D. Collen Research Foundation Vzw Onderwijsen Navorsing Campus Gasthuisberg K.U. Leuven | Recombinant molecules with reduced immunogenicity, methods and intermediates for obtaining them and their use in pharmaceutical compositions and diagnostic tools |
| CA2450125A1 (en) | 2001-06-15 | 2002-12-27 | Andre C. Schuh | Gene therapy for hemophilia a |
| US7041635B2 (en) * | 2003-01-28 | 2006-05-09 | In2Gen Co., Ltd. | Factor VIII polypeptide |
| PL2298347T3 (pl) | 2003-05-06 | 2016-03-31 | Bioverativ Therapeutics Inc | Białka chimeryczne czynnika krzepnięcia do leczenia zaburzenia hemostazy |
| CA2656558A1 (en) | 2006-06-30 | 2008-01-10 | The Regents Of The University Of Michigan | Method of producing factor viii proteins by recombinant methods |
| CA2673459C (en) * | 2006-12-22 | 2016-09-13 | Stefan Schulte | Modified coagulation factors with prolonged in vivo half-life |
| JP5739865B2 (ja) * | 2009-03-24 | 2015-06-24 | バイエル・ヘルスケア・エルエルシー | 第ｖｉｉｉ因子変異体および使用の方法 |
| WO2011020866A2 (en) | 2009-08-20 | 2011-02-24 | Csl Behring Gmbh | Albumin fused coagulation factors for non-intravenous administration in the therapy and prophylactic treatment of bleeding disorders |
| GB0915480D0 (en) | 2009-09-04 | 2009-10-07 | Arecor Ltd | Stable formulation of factor viii |
| KR20140084208A (ko) | 2011-10-18 | 2014-07-04 | 시에스엘 리미티드 | 정제된 인자 ｖｉｉｉ의 재구성 후의 안정성을 향상시키는 방법 |
| US9534029B2 (en) | 2012-10-03 | 2017-01-03 | Csl Behring Ag | Method of purifying proteins |
-
2012
- 2012-10-18 KR KR1020147013298A patent/KR20140084208A/ko not_active Ceased
- 2012-10-18 CN CN201280051574.0A patent/CN103917554B/zh active Active
- 2012-10-18 CA CA2850579A patent/CA2850579A1/en not_active Abandoned
- 2012-10-18 EP EP12772987.9A patent/EP2768853A1/en not_active Ceased
- 2012-10-18 JP JP2014536237A patent/JP2014531910A/ja not_active Withdrawn
- 2012-10-18 WO PCT/EP2012/070701 patent/WO2013057219A1/en not_active Ceased
- 2012-10-18 HK HK14112047.2A patent/HK1198541A1/xx unknown
- 2012-10-18 US US14/351,513 patent/US9394353B2/en active Active
- 2012-10-18 AU AU2012318292A patent/AU2012318292B2/en active Active
-
2016
- 2016-05-17 US US15/156,744 patent/US9956269B2/en active Active
-
2017
- 2017-02-17 JP JP2017027545A patent/JP2017114889A/ja active Pending
-
2018
- 2018-02-20 US US15/899,510 patent/US10537616B2/en active Active
-
2019
- 2019-12-03 US US16/701,468 patent/US10881717B2/en not_active Expired - Fee Related
-
2020
- 2020-12-02 US US17/109,366 patent/US11510968B2/en active Active
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