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
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- 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
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- 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
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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 | ||
| EP11185651.4 | 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 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2850579A1 true CA2850579A1 (en) | 2013-04-25 |
Family
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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 (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=) |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| 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
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2016
- 2016-05-17 US US15/156,744 patent/US9956269B2/en active Active
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2017
- 2017-02-17 JP JP2017027545A patent/JP2017114889A/ja active Pending
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2018
- 2018-02-20 US US15/899,510 patent/US10537616B2/en active Active
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2019
- 2019-12-03 US US16/701,468 patent/US10881717B2/en not_active Expired - Fee Related
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2020
- 2020-12-02 US US17/109,366 patent/US11510968B2/en active Active
Also Published As
| Publication number | Publication date |
|---|---|
| US10881717B2 (en) | 2021-01-05 |
| US11510968B2 (en) | 2022-11-29 |
| US20200268854A1 (en) | 2020-08-27 |
| US10537616B2 (en) | 2020-01-21 |
| WO2013057219A1 (en) | 2013-04-25 |
| US20160367641A1 (en) | 2016-12-22 |
| US9394353B2 (en) | 2016-07-19 |
| US20190038722A1 (en) | 2019-02-07 |
| JP2017114889A (ja) | 2017-06-29 |
| US20210308229A1 (en) | 2021-10-07 |
| CN103917554B (zh) | 2017-03-08 |
| JP2014531910A (ja) | 2014-12-04 |
| AU2012318292A1 (en) | 2013-05-02 |
| AU2012318292B2 (en) | 2015-08-20 |
| EP2768853A1 (en) | 2014-08-27 |
| KR20140084208A (ko) | 2014-07-04 |
| US9956269B2 (en) | 2018-05-01 |
| US20140249086A1 (en) | 2014-09-04 |
| CN103917554A (zh) | 2014-07-09 |
| HK1198541A1 (en) | 2015-05-15 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request |
Effective date: 20170918 |
|
| FZDE | Discontinued |
Effective date: 20211115 |