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 PDF

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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
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Australia
Prior art keywords
factor viii
amino acid
fviii
deleted
fused
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AU2012318292A
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AU2012318292A1 (en
Inventor
Carsten Horn
Hubert Metzner
Stefan Schulte
Sabine ZOLLNER
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CSL Ltd
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CSL Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/36Blood coagulation or fibrinolysis factors
    • A61K38/37Factors VIII
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/745Blood coagulation or fibrinolysis factors
    • C07K14/755Factors VIII, e.g. factor VIII C (AHF), factor VIII Ag (VWF)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides

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  • 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)
AU2012318292A 2011-10-18 2012-10-18 Method for improving the stability of purified Factor VIII after reconstitution Active AU2012318292B2 (en)

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

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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)

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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

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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

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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
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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

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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

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