AU2012318292B2 - Method for improving the stability of purified Factor VIII after reconstitution - Google Patents
Method for improving the stability of purified Factor VIII after reconstitution Download PDFInfo
- Publication number
- AU2012318292B2 AU2012318292B2 AU2012318292A AU2012318292A AU2012318292B2 AU 2012318292 B2 AU2012318292 B2 AU 2012318292B2 AU 2012318292 A AU2012318292 A AU 2012318292A AU 2012318292 A AU2012318292 A AU 2012318292A AU 2012318292 B2 AU2012318292 B2 AU 2012318292B2
- Authority
- AU
- Australia
- Prior art keywords
- factor viii
- amino acid
- fviii
- deleted
- fused
- 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
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
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- C07K14/745—Blood coagulation or fibrinolysis factors
- C07K14/755—Factors VIII, e.g. factor VIII C (AHF), factor VIII Ag (VWF)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Hematology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Gastroenterology & Hepatology (AREA)
- Zoology (AREA)
- Engineering & Computer Science (AREA)
- Pharmacology & Pharmacy (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Biochemistry (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Toxicology (AREA)
- Molecular Biology (AREA)
- Epidemiology (AREA)
- Immunology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Diabetes (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Peptides Or Proteins (AREA)
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 | 2011-10-18 | ||
| EP11185651.4 | 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 |
|---|---|---|---|
| AU2015258240A Division AU2015258240A1 (en) | 2011-10-18 | 2015-11-19 | Method of improving the stability of purified factor viii after reconstitution |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| AU2012318292A1 AU2012318292A1 (en) | 2013-05-02 |
| AU2012318292B2 true AU2012318292B2 (en) | 2015-08-20 |
Family
ID=48140377
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| AU2012318292A Active AU2012318292B2 (en) | 2011-10-18 | 2012-10-18 | Method for improving the stability of purified Factor VIII after reconstitution |
Country Status (9)
| Country | Link |
|---|---|
| US (5) | US9394353B2 (enExample) |
| EP (1) | EP2768853A1 (enExample) |
| JP (2) | JP2014531910A (enExample) |
| KR (1) | KR20140084208A (enExample) |
| CN (1) | CN103917554B (enExample) |
| AU (1) | AU2012318292B2 (enExample) |
| CA (1) | CA2850579A1 (enExample) |
| HK (1) | HK1198541A1 (enExample) |
| WO (1) | WO2013057219A1 (enExample) |
Families Citing this family (20)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| HK1198541A1 (en) | 2011-10-18 | 2015-05-15 | Csl Limited | Method for improving the stability of purified factor viii after reconstitution |
| PL3666283T3 (pl) * | 2013-03-15 | 2022-10-03 | Bioverativ Therapeutics Inc. | Formulacje polipeptydu czynnika viii |
| AU2015240354A1 (en) * | 2014-04-01 | 2016-11-17 | Advantech Bioscience Farmaceutica Ltda. | Stabilization of Factor VIII without calcium as an excipient |
| MX2016012870A (es) * | 2014-04-01 | 2017-05-12 | Advantech Bioscience Farmacêutica Ltda | Formulaciones de factor viii estables con bajo tenor de azucar - glicina. |
| PL3193911T3 (pl) * | 2014-07-25 | 2024-03-11 | Csl Behring Gmbh | Ulepszone preparaty czynnika VIII do stosowania do leczenia hemofilii A |
| JP6516829B2 (ja) | 2014-08-04 | 2019-05-22 | シーエスエル、リミテッド | 第viii因子製剤 |
| JP6877469B2 (ja) | 2016-06-24 | 2021-05-26 | 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Mogam Institute For Biomedical Research | Fviiiおよびvwf因子を含むキメラタンパク質、ならびにそれらの使用 |
| CN109689683A (zh) * | 2016-06-24 | 2019-04-26 | 财团法人牧岩生命科学研究所 | 重组单链fvⅲ及其化学缀合物 |
| WO2018102743A1 (en) | 2016-12-02 | 2018-06-07 | Bioverativ Therapeutics Inc. | Methods of treating hemophilic arthropathy using chimeric clotting factors |
| US20200263196A1 (en) | 2017-09-27 | 2020-08-20 | Sigilon Therapeutics, Inc. | Methods, compositions, and implantable elements comprising active cells |
| CA3078625C (en) | 2017-10-09 | 2023-01-17 | Terumo Bct Biotechnologies, Llc | Lyophilization container and method of using same |
| WO2019195056A1 (en) | 2018-04-04 | 2019-10-10 | Sigilon Therapeutics, Inc. | Methods, compositions, and implantable elements comprising stem cells |
| TW202014181A (zh) | 2018-04-04 | 2020-04-16 | 美商希吉隆醫療公司 | 可植入顆粒及相關方法 |
| MA53020A (fr) | 2018-05-18 | 2021-05-05 | Zhengzhou Gensciences Inc | Protéine de fusion du fviii améliorée et utilisation associée |
| RS66972B1 (sr) | 2018-05-18 | 2025-07-31 | Bioverativ Therapeutics Inc | Metode lečenja hemofilije a |
| UY38389A (es) | 2018-09-27 | 2020-04-30 | Sigilon Therapeutics Inc | Dispositivos implantables para terapia celular y métodos relacionados |
| CA3224729A1 (en) | 2019-03-14 | 2020-09-17 | Terumo Bct Biotechnologies, Llc | Lyophilization loading tray assembly and system |
| EP3736286A1 (en) | 2019-05-09 | 2020-11-11 | Biotest AG | Single chain factor viii molecule |
| WO2024081310A1 (en) | 2022-10-11 | 2024-04-18 | Sigilon Therapeutics, Inc. | Engineered cells and implantable elements for treatment of disease |
| EP4602155A1 (en) | 2022-10-11 | 2025-08-20 | Sigilon Therapeutics, Inc. | Engineered cells and implantable elements for treatment of disease |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2004067566A1 (en) * | 2003-01-28 | 2004-08-12 | In2Gen Co., Ltd. | Factor viii polypeptide |
| WO2008077616A1 (en) * | 2006-12-22 | 2008-07-03 | Csl Behring Gmbh | Modified coagulation factors with prolonged in vivo half-life |
| WO2010111414A1 (en) * | 2009-03-24 | 2010-09-30 | Bayer Healthcare Llc | Factor viii variants and methods of use |
Family Cites Families (27)
| 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 |
| JPH0788399B2 (ja) | 1985-04-12 | 1995-09-27 | ジェネティックス・インスチチュ−ト・インコ−ポレ−テッド | 新規プロコアギュラント蛋白質 |
| 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 |
| EP0690126B1 (en) | 1987-06-12 | 2001-11-28 | Baxter Aktiengesellschaft | Novel proteins with factor VIII activitiy: 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 |
| DE69735421T2 (de) | 1996-04-24 | 2006-10-19 | The Regents Of The University Of Michigan, Ann Arbor | Gegen inaktivierung resistenter faktor viii |
| AU1598200A (en) | 1998-10-23 | 2000-05-15 | Trustees Of The University Of Pennsylvania, The | Systemic delivery of gene products via skin |
| NZ516400A (en) | 1999-07-13 | 2004-02-27 | Biovitrum Ab | Stable factor VIII compositions |
| EP1460131A3 (en) | 2000-03-22 | 2005-06-01 | Octagene GmbH | Production of recombinant blood clotting factors in human cell lines |
| AU2002312660A1 (en) * | 2001-05-31 | 2002-12-16 | 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 |
| US20040192599A1 (en) | 2001-06-15 | 2004-09-30 | Schuh Andre C | Gene therapy for hemophilia a |
| DE602004031390D1 (de) | 2003-05-06 | 2011-03-24 | Syntonix Pharmaceuticals Inc | Gerinnungsfaktor VII-Fc chimäre Proteine zur Behandlung von hämostatischen Krankheiten |
| US20080070251A1 (en) | 2006-06-30 | 2008-03-20 | Kaufman Randal J | Method of Producing Factor VIII Proteins by Recombinant Methods |
| CA2770609A1 (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 |
| HK1198541A1 (en) | 2011-10-18 | 2015-05-15 | Csl Limited | Method for improving the stability of purified factor viii after reconstitution |
| US9534029B2 (en) | 2012-10-03 | 2017-01-03 | Csl Behring Ag | Method of purifying proteins |
-
2012
- 2012-10-18 HK HK14112047.2A patent/HK1198541A1/xx unknown
- 2012-10-18 KR KR1020147013298A patent/KR20140084208A/ko not_active Ceased
- 2012-10-18 WO PCT/EP2012/070701 patent/WO2013057219A1/en not_active Ceased
- 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 US US14/351,513 patent/US9394353B2/en active Active
- 2012-10-18 AU AU2012318292A patent/AU2012318292B2/en active Active
- 2012-10-18 CA CA2850579A patent/CA2850579A1/en not_active Abandoned
- 2012-10-18 CN CN201280051574.0A patent/CN103917554B/zh 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
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2004067566A1 (en) * | 2003-01-28 | 2004-08-12 | In2Gen Co., Ltd. | Factor viii polypeptide |
| WO2008077616A1 (en) * | 2006-12-22 | 2008-07-03 | Csl Behring Gmbh | Modified coagulation factors with prolonged in vivo half-life |
| WO2010111414A1 (en) * | 2009-03-24 | 2010-09-30 | Bayer Healthcare Llc | Factor viii variants and methods of use |
Non-Patent Citations (3)
| Title |
|---|
| DONATH M-J. S. H., et al, Biochemistry Journal, 1995, Vol. 312, pages 49-55. * |
| EATON D. L. et al, Biochemistry, 1986, Vol. 25, No. 26, pages 8343-8347. * |
| SANDBERG H., et al, Seminars in Hematology, 2001, Vol. 38, No. 2, Suppl 4, pages 4-12. * |
Also Published As
| Publication number | Publication date |
|---|---|
| EP2768853A1 (en) | 2014-08-27 |
| CN103917554A (zh) | 2014-07-09 |
| US20190038722A1 (en) | 2019-02-07 |
| US20210308229A1 (en) | 2021-10-07 |
| US20200268854A1 (en) | 2020-08-27 |
| US11510968B2 (en) | 2022-11-29 |
| CN103917554B (zh) | 2017-03-08 |
| US20140249086A1 (en) | 2014-09-04 |
| WO2013057219A1 (en) | 2013-04-25 |
| US9956269B2 (en) | 2018-05-01 |
| JP2017114889A (ja) | 2017-06-29 |
| HK1198541A1 (en) | 2015-05-15 |
| AU2012318292A1 (en) | 2013-05-02 |
| US20160367641A1 (en) | 2016-12-22 |
| US9394353B2 (en) | 2016-07-19 |
| US10537616B2 (en) | 2020-01-21 |
| CA2850579A1 (en) | 2013-04-25 |
| KR20140084208A (ko) | 2014-07-04 |
| US10881717B2 (en) | 2021-01-05 |
| JP2014531910A (ja) | 2014-12-04 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| US11510968B2 (en) | Method for improving the stability of purified Factor VIII after reconstitution | |
| JP6250282B2 (ja) | 出血性障害の治療および予防的治療における非静脈内投与のためのアルブミン融合凝固因子 | |
| JP5832285B2 (ja) | 延長されたインビボ半減期を有する第viii因子、フォン・ヴィレブランド因子又はそれらの複合体 | |
| US9107902B2 (en) | Use of VWF stabilized FVIII preparations and of VWF preparations without FVIII for extravascular administration in the therapy and prophylactic treatment of bleeding disorders | |
| ES2657291T3 (es) | Un complejo covalente de factor de von Willebrand y factor VIII asociado por un puente disulfuro | |
| KR20090102795A (ko) | 연장된 생체내 반감기를 갖는 변형된 응고 인자 | |
| RS66972B1 (sr) | Metode lečenja hemofilije a | |
| US11560436B2 (en) | Anti-VWF D'D3 single-domain antibodies fuse to clotting factors | |
| US20220259287A1 (en) | Single chain factor viii molecule | |
| AU2015258240A1 (en) | Method of improving the stability of purified factor viii after reconstitution | |
| US20230190881A1 (en) | Subcutaneous administration of factor viii | |
| EP3785726A1 (en) | Factor viii protein with increased half-life | |
| HK40079628A (en) | Subcutaneous administration of factor viii |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FGA | Letters patent sealed or granted (standard patent) |