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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    • 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

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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
EP11185651.4 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
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 (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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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

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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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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
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CA2656558A1 (en) 2006-06-30 2008-01-10 The Regents Of The University Of Michigan Method of producing factor viii proteins by recombinant methods
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
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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
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
EP2768853A1 (en) 2014-08-27
CA2850579A1 (en) 2013-04-25
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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