CA2850579A1 - 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
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- CA2850579A1 CA2850579A1 CA2850579A CA2850579A CA2850579A1 CA 2850579 A1 CA2850579 A1 CA 2850579A1 CA 2850579 A CA2850579 A CA 2850579A CA 2850579 A CA2850579 A CA 2850579A CA 2850579 A1 CA2850579 A1 CA 2850579A1
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- factor viii
- molecule
- fviii
- proteolytic cleavage
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- 230000007774 longterm Effects 0.000 description 1
- 208000018773 low birth weight Diseases 0.000 description 1
- 231100000533 low birth weight Toxicity 0.000 description 1
- 239000012931 lyophilized formulation Substances 0.000 description 1
- 229920002521 macromolecule Polymers 0.000 description 1
- 230000036210 malignancy Effects 0.000 description 1
- 239000000594 mannitol Substances 0.000 description 1
- 229910021645 metal ion Inorganic materials 0.000 description 1
- 229920000620 organic polymer Polymers 0.000 description 1
- 239000006179 pH buffering agent Substances 0.000 description 1
- 230000000149 penetrating effect Effects 0.000 description 1
- 208000011906 peptic ulcer disease Diseases 0.000 description 1
- 230000007030 peptide scission Effects 0.000 description 1
- COLNVLDHVKWLRT-UHFFFAOYSA-N phenylalanine Natural products OC(=O)C(N)CC1=CC=CC=C1 COLNVLDHVKWLRT-UHFFFAOYSA-N 0.000 description 1
- 235000008729 phenylalanine Nutrition 0.000 description 1
- 239000002504 physiological saline solution Substances 0.000 description 1
- 210000002826 placenta Anatomy 0.000 description 1
- 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 description 1
- 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 description 1
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 description 1
- 229940068977 polysorbate 20 Drugs 0.000 description 1
- 229940068968 polysorbate 80 Drugs 0.000 description 1
- 239000001103 potassium chloride Substances 0.000 description 1
- 235000011164 potassium chloride Nutrition 0.000 description 1
- 230000002028 premature Effects 0.000 description 1
- 239000003755 preservative agent Substances 0.000 description 1
- 230000002265 prevention Effects 0.000 description 1
- 238000012545 processing Methods 0.000 description 1
- 230000000069 prophylactic effect Effects 0.000 description 1
- 230000001681 protective effect Effects 0.000 description 1
- 229960000856 protein c Drugs 0.000 description 1
- 230000002797 proteolythic effect Effects 0.000 description 1
- 239000002510 pyrogen Substances 0.000 description 1
- 102000005962 receptors Human genes 0.000 description 1
- 108020003175 receptors Proteins 0.000 description 1
- 238000003259 recombinant expression Methods 0.000 description 1
- 238000010188 recombinant method Methods 0.000 description 1
- 238000011084 recovery Methods 0.000 description 1
- 210000003660 reticulum Anatomy 0.000 description 1
- 238000012552 review Methods 0.000 description 1
- 238000005070 sampling Methods 0.000 description 1
- 235000004400 serine Nutrition 0.000 description 1
- 239000001509 sodium citrate Substances 0.000 description 1
- 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 description 1
- 239000000600 sorbitol Substances 0.000 description 1
- 241000894007 species Species 0.000 description 1
- 230000006641 stabilisation Effects 0.000 description 1
- 238000011105 stabilization Methods 0.000 description 1
- 230000000087 stabilizing effect Effects 0.000 description 1
- 239000008227 sterile water for injection Substances 0.000 description 1
- 235000000346 sugar Nutrition 0.000 description 1
- 150000008163 sugars Chemical class 0.000 description 1
- 229940124597 therapeutic agent Drugs 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
- 235000008521 threonine Nutrition 0.000 description 1
- 231100000607 toxicokinetics Toxicity 0.000 description 1
- 231100000041 toxicology testing Toxicity 0.000 description 1
- 230000005945 translocation Effects 0.000 description 1
- 230000014599 transmission of virus Effects 0.000 description 1
- 238000002054 transplantation Methods 0.000 description 1
- 230000032258 transport Effects 0.000 description 1
- 230000008733 trauma Effects 0.000 description 1
- LENZDBCJOHFCAS-UHFFFAOYSA-N tris Chemical compound OCC(N)(CO)CO LENZDBCJOHFCAS-UHFFFAOYSA-N 0.000 description 1
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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
- 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
-
- 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
- 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 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2850579A1 true CA2850579A1 (en) | 2013-04-25 |
Family
ID=48140377
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA2850579A Abandoned CA2850579A1 (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 |
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 |
| 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 |
| US7041635B2 (en) * | 2003-01-28 | 2006-05-09 | In2Gen Co., Ltd. | Factor VIII polypeptide |
| 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 |
| EP3231440A1 (en) * | 2006-12-22 | 2017-10-18 | CSL Behring GmbH | Modified coagulation factors with prolonged in vivo half-life |
| CN102427823A (zh) * | 2009-03-24 | 2012-04-25 | 拜耳医药保健有限公司 | 因子viii变体及使用方法 |
| 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
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 |
| AU2012318292B2 (en) | 2015-08-20 |
| US9394353B2 (en) | 2016-07-19 |
| US10537616B2 (en) | 2020-01-21 |
| KR20140084208A (ko) | 2014-07-04 |
| US10881717B2 (en) | 2021-01-05 |
| JP2014531910A (ja) | 2014-12-04 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request |
Effective date: 20170918 |
|
| FZDE | Discontinued |
Effective date: 20211115 |