DK0871476T3 - Tørret blodfaktorpræparat indeholdende trehalose - Google Patents

Tørret blodfaktorpræparat indeholdende trehalose

Info

Publication number
DK0871476T3
DK0871476T3 DK96900633T DK96900633T DK0871476T3 DK 0871476 T3 DK0871476 T3 DK 0871476T3 DK 96900633 T DK96900633 T DK 96900633T DK 96900633 T DK96900633 T DK 96900633T DK 0871476 T3 DK0871476 T3 DK 0871476T3
Authority
DK
Denmark
Prior art keywords
blood factor
preparation containing
dried blood
containing trehalose
factor preparation
Prior art date
Application number
DK96900633T
Other languages
English (en)
Inventor
Bruce Joseph Roser
Original Assignee
Elan Drug Delivery Ltd
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Elan Drug Delivery Ltd filed Critical Elan Drug Delivery Ltd
Application granted granted Critical
Publication of DK0871476T3 publication Critical patent/DK0871476T3/da

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/14Blood; Artificial blood
    • 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
    • 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
    • A61K38/43Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46Hydrolases (3)
    • A61K38/48Hydrolases (3) acting on peptide bonds (3.4)
    • A61K38/482Serine endopeptidases (3.4.21)
    • A61K38/4846Factor VII (3.4.21.21); Factor IX (3.4.21.22); Factor Xa (3.4.21.6); Factor XI (3.4.21.27); Factor XII (3.4.21.38)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • 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
    • 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
DK96900633T 1995-01-19 1996-01-19 Tørret blodfaktorpræparat indeholdende trehalose DK0871476T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GBGB9501040.1A GB9501040D0 (en) 1995-01-19 1995-01-19 Dried composition
PCT/GB1996/000119 WO1996022107A1 (en) 1995-01-19 1996-01-19 Dried blood factor composition comprising trehalose

Publications (1)

Publication Number Publication Date
DK0871476T3 true DK0871476T3 (da) 2003-11-10

Family

ID=10768253

Family Applications (2)

Application Number Title Priority Date Filing Date
DK03002147T DK1308170T3 (da) 1995-01-19 1996-01-19 Törret blodfaktorpræparat indeholdende trehalose
DK96900633T DK0871476T3 (da) 1995-01-19 1996-01-19 Tørret blodfaktorpræparat indeholdende trehalose

Family Applications Before (1)

Application Number Title Priority Date Filing Date
DK03002147T DK1308170T3 (da) 1995-01-19 1996-01-19 Törret blodfaktorpræparat indeholdende trehalose

Country Status (15)

Country Link
US (2) US6649386B2 (da)
EP (4) EP0871476B1 (da)
JP (1) JP3898221B2 (da)
KR (1) KR100417593B1 (da)
CN (1) CN1152713C (da)
AT (2) ATE413885T1 (da)
AU (1) AU704317B2 (da)
CA (2) CA2210872C (da)
DE (2) DE69629209T2 (da)
DK (2) DK1308170T3 (da)
ES (2) ES2316658T3 (da)
GB (1) GB9501040D0 (da)
PT (2) PT871476E (da)
SI (1) SI1308170T1 (da)
WO (1) WO1996022107A1 (da)

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US7253262B2 (en) * 1995-01-19 2007-08-07 Quandrant Drug Delivery Limited Dried blood factor composition comprising trehalose
GB9501040D0 (en) * 1995-01-19 1995-03-08 Quadrant Holdings Cambridge Dried composition
US7244824B2 (en) * 1995-01-19 2007-07-17 Quadrant Drug Delivery Limited Dried blood factor composition comprising trehalose
US6964771B1 (en) 1995-06-07 2005-11-15 Elan Drug Delivery Limited Method for stably incorporating substances within dry, foamed glass matrices
US6632648B1 (en) * 1996-05-14 2003-10-14 Elan Drug Delivery Limited Methods of terminal sterilization of fibrinogen
GB9616536D0 (en) 1996-08-06 1996-09-25 Quadrant Holdings Cambridge Co-amoxiclav dosage form
AUPO871997A0 (en) * 1997-08-25 1997-09-18 Csl Limited Dried biologically or therapeutically active preparations
CA2634663C (en) 1999-02-22 2009-08-25 University Of Connecticut Novel albumin-free factor viii formulations
BR0211842A (pt) * 2001-08-10 2004-08-31 Hayashibara Biochem Lab Associado, processos para produzir um associado de trealose ou maltitol e um ou mais compostos de ìon metálico, um produto em pó e um alimento marinho seco, método para formar um associado de trealose ou maltitol e um ou mais compostos de ìon metálico, composição, produto em pó, agente e tempero para alimentos
JP2007505147A (ja) 2003-09-12 2007-03-08 アンティジェニクス インコーポレーテッド 単純ヘルペスウイルス感染の治療および予防用ワクチン
WO2005094873A1 (en) * 2004-03-19 2005-10-13 Baxter International Inc. Factor ixa for the treatment of bleeding disorders
EP1758937B1 (en) 2004-05-24 2009-09-02 Genvault Corporation Stable protein storage and stable nucleic acid storage in recoverable form
KR100624013B1 (ko) 2004-06-25 2006-09-19 주식회사 녹십자홀딩스 동결건조된 알부민 비함유 재조합 사람 혈액응고 제 8인자 제제
US8133484B2 (en) 2006-12-15 2012-03-13 Lifebond Ltd Hemostatic materials and dressing
CA2673260A1 (en) * 2006-12-20 2008-07-03 Bayer Healthcare Llc Factor vii and viia compositions
EP1958618A1 (de) * 2007-02-15 2008-08-20 Octapharma AG Verfahren zur Gefriertrocknung mit optimierter Rekonstitution von Biopolymeren
CA2991162A1 (en) * 2007-12-21 2009-07-02 Aptevo Biotherapeutics Llc Stabilized factor ix formulations containing trehalose
US11197916B2 (en) 2007-12-28 2021-12-14 Takeda Pharmaceutical Company Limited Lyophilized recombinant VWF formulations
TWI515006B (zh) * 2007-12-28 2016-01-01 巴克斯特國際公司 重組vwf調配物
CN102177237B (zh) 2008-09-12 2013-10-30 金沃特公司 用于贮存和稳定生物分子的基质和介质
BRPI0919693A2 (pt) 2008-10-21 2020-08-11 Baxter Healthcare S.A formulação farmacêutica estável liofilizada
JP5779780B2 (ja) 2008-11-07 2015-09-16 バクスター・インターナショナル・インコーポレイテッドBaxter International Incorp0Rated 第viii因子製剤
BR112012015029A2 (pt) 2009-12-22 2017-06-27 Lifebond Ltd matriz reticulada, método para controlar a formação de uma matriz, método ou matriz, método para vedar um tecido contra vazamento de um fluído corporal, agente hemostático ou vedante cirúrgico, composição para vedar um ferimento, uso da composição, composição para um veículo para entrega localizada de fármaco, composição para engenharia de tecido, e método para modificar uma composição
EP2732262A4 (en) * 2011-07-13 2014-12-10 Denator Ab PROCESS FOR STABILIZING LIQUID BIOLOGICAL SAMPLES
CN102416171B (zh) * 2011-12-06 2013-12-25 中国医学科学院输血研究所 高纯度凝血酶原复合物制品干热病毒灭活过程中的保护剂
US9700486B2 (en) 2013-04-24 2017-07-11 Corning Incorporated Delamination resistant pharmaceutical glass containers containing active pharmaceutical ingredients
US20160317646A1 (en) * 2013-12-19 2016-11-03 Crucell Holland B.V. Formulations for virosomes
MX2017000862A (es) 2014-08-04 2017-05-01 Csl Ltd Formulacion de factor viii.
EA201792501A1 (ru) 2015-05-13 2018-10-31 Эйдженус Инк. Вакцины для лечения и профилактики рака
CN107333750A (zh) * 2017-06-11 2017-11-10 成都吱吖科技有限公司 一种长时血液细胞稳定剂
JP2021522239A (ja) 2018-04-26 2021-08-30 アジェナス インコーポレイテッド 熱ショックタンパク質結合ペプチド組成物およびその使用方法
WO2021001522A1 (en) 2019-07-04 2021-01-07 CSL Behring Lengnau AG A truncated von willebrand factor (vwf) for increasing the in vitro stability of coagulation factor viii
EP4240757A2 (en) 2020-11-09 2023-09-13 Takeda Pharmaceutical Company Limited Purification of fviii from plasma using silicon oxide adsorption
WO2022261716A1 (en) * 2021-06-16 2022-12-22 Exopharm Limited Aqueous formulations for preservation of extracellular vesicles

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US4361509A (en) 1981-12-14 1982-11-30 Scripps Clinic And Research Foundation Ultrapurification of factor VIII using monoclonal antibodies
US4495175A (en) * 1982-08-05 1985-01-22 University Of Rochester Preparation of highly purified human antihemophilic factor
FI86885C (fi) 1984-04-20 1992-10-26 Genentech Inc Foerfarande foer framstaellning av human rekombinantfaktor viii och nukleinsyrasekvenser och vektorer anvaend daertill
EP0182448A3 (en) 1984-08-24 1987-10-28 Genetics Institute, Inc. Production of factor viii and related products
DE3682047D1 (de) * 1985-07-09 1991-11-21 Quadrant Bioresources Ltd Beschuetzung von proteinen und aehnlichem.
US4758657A (en) * 1985-07-11 1988-07-19 Armour Pharmaceutical Company Method of purifying Factor VIII:C
US4806343A (en) * 1986-03-13 1989-02-21 University Of Southwestern Louisiana Cryogenic protectant for proteins
CA1329760C (en) * 1987-10-29 1994-05-24 Ted C. K. Lee Plasma and recombinant protein formulations in high ionic strength media
US4877608A (en) * 1987-11-09 1989-10-31 Rorer Pharmaceutical Corporation Pharmaceutical plasma protein formulations in low ionic strength media
CA2051092C (en) * 1990-09-12 2002-07-23 Stephen A. Livesey Method and apparatus for cryopreparation, dry stabilization and rehydration of biological suspensions
DE4111393A1 (de) 1991-04-09 1992-10-15 Behringwerke Ag Stabilisierte faktor viii-praeparationen
US5288853A (en) 1992-04-30 1994-02-22 Alpha Therapeutic Corporation Factor viii purification process
WO1994007510A1 (en) * 1992-10-02 1994-04-14 Kabi Pharmacia Ab Composition comprising coagulation factor viii formulation, process for its preparation and use of a surfactant as stabilizer
SE504074C2 (sv) * 1993-07-05 1996-11-04 Pharmacia Ab Proteinberedning för subkutan, intramuskulär eller intradermal administrering
WO1995003332A1 (en) 1993-07-23 1995-02-02 Baxter International Inc. Activated human factor viii and method of preparation
US5576291A (en) * 1993-09-13 1996-11-19 Baxter International Inc. Activated factor VIII as a therapeutic agent and method of treating factor VIII deficiency
US5955448A (en) 1994-08-19 1999-09-21 Quadrant Holdings Cambridge Limited Method for stabilization of biological substances during drying and subsequent storage and compositions thereof
US7253262B2 (en) * 1995-01-19 2007-08-07 Quandrant Drug Delivery Limited Dried blood factor composition comprising trehalose
GB9501040D0 (en) * 1995-01-19 1995-03-08 Quadrant Holdings Cambridge Dried composition
US5804420A (en) * 1997-04-18 1998-09-08 Bayer Corporation Preparation of recombinant Factor VIII in a protein free medium
CA2634663C (en) 1999-02-22 2009-08-25 University Of Connecticut Novel albumin-free factor viii formulations

Also Published As

Publication number Publication date
EP2258402A2 (en) 2010-12-08
CN1152713C (zh) 2004-06-09
CA2671383A1 (en) 1996-07-25
US6649386B2 (en) 2003-11-18
CA2210872A1 (en) 1996-07-25
EP1308170A3 (en) 2004-03-03
KR100417593B1 (ko) 2004-04-30
SI1308170T1 (sl) 2009-04-30
CA2210872C (en) 2009-09-08
WO1996022107A1 (en) 1996-07-25
GB9501040D0 (en) 1995-03-08
EP1974741A1 (en) 2008-10-01
JP3898221B2 (ja) 2007-03-28
CA2671383C (en) 2012-04-24
DE69629209D1 (de) 2003-08-28
JPH11503719A (ja) 1999-03-30
PT1308170E (pt) 2008-12-26
EP2258402A3 (en) 2011-01-05
ATE245442T1 (de) 2003-08-15
CN1179107A (zh) 1998-04-15
AU704317B2 (en) 1999-04-22
ES2316658T3 (es) 2009-04-16
KR19980701500A (ko) 1998-05-15
PT871476E (pt) 2003-12-31
ES2202425T3 (es) 2004-04-01
EP0871476A1 (en) 1998-10-21
ATE413885T1 (de) 2008-11-15
DE69637749D1 (de) 2008-12-24
US20090149388A1 (en) 2009-06-11
US20020128207A1 (en) 2002-09-12
EP0871476B1 (en) 2003-07-23
US7803911B2 (en) 2010-09-28
EP1308170A2 (en) 2003-05-07
DK1308170T3 (da) 2008-12-15
AU4454096A (en) 1996-08-07
EP1308170B1 (en) 2008-11-12
DE69629209T2 (de) 2004-02-19

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