PT871476E - Composicao seca de factor sanguineo compreendendo trealose - Google Patents

Composicao seca de factor sanguineo compreendendo trealose

Info

Publication number
PT871476E
PT871476E PT96900633T PT96900633T PT871476E PT 871476 E PT871476 E PT 871476E PT 96900633 T PT96900633 T PT 96900633T PT 96900633 T PT96900633 T PT 96900633T PT 871476 E PT871476 E PT 871476E
Authority
PT
Portugal
Prior art keywords
trealose
comprehending
blood factor
dry composition
stable
Prior art date
Application number
PT96900633T
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
Publication of PT871476E publication Critical patent/PT871476E/pt

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/14—Blood; Artificial blood
    • 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
    • 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
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
    • A61K38/482—Serine endopeptidases (3.4.21)
    • A61K38/4846—Factor 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)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate 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
    • 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
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Hematology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Diabetes (AREA)
  • Biotechnology (AREA)
  • Cell Biology (AREA)
  • Developmental Biology & Embryology (AREA)
  • Virology (AREA)
  • Dermatology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
PT96900633T 1995-01-19 1996-01-19 Composicao seca de factor sanguineo compreendendo trealose PT871476E (pt)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
GBGB9501040.1A GB9501040D0 (en) 1995-01-19 1995-01-19 Dried composition

Publications (1)

Publication Number Publication Date
PT871476E true PT871476E (pt) 2003-12-31

Family

ID=10768253

Family Applications (2)

Application Number Title Priority Date Filing Date
PT03002147T PT1308170E (pt) 1995-01-19 1996-01-19 Composição seca de factor sanguíneo que compreende trealose
PT96900633T PT871476E (pt) 1995-01-19 1996-01-19 Composicao seca de factor sanguineo compreendendo trealose

Family Applications Before (1)

Application Number Title Priority Date Filing Date
PT03002147T PT1308170E (pt) 1995-01-19 1996-01-19 Composição seca de factor sanguíneo que compreende trealose

Country Status (15)

Country Link
US (2) US6649386B2 (pt)
EP (4) EP0871476B1 (pt)
JP (1) JP3898221B2 (pt)
KR (1) KR100417593B1 (pt)
CN (1) CN1152713C (pt)
AT (2) ATE413885T1 (pt)
AU (1) AU704317B2 (pt)
CA (2) CA2210872C (pt)
DE (2) DE69637749D1 (pt)
DK (2) DK1308170T3 (pt)
ES (2) ES2316658T3 (pt)
GB (1) GB9501040D0 (pt)
PT (2) PT1308170E (pt)
SI (1) SI1308170T1 (pt)
WO (1) WO1996022107A1 (pt)

Families Citing this family (36)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7244824B2 (en) * 1995-01-19 2007-07-17 Quadrant Drug Delivery Limited Dried blood factor composition comprising trehalose
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
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
JP4340151B2 (ja) * 2001-08-10 2009-10-07 株式会社林原生物化学研究所 トレハロース又はマルチトールと金属イオン化合物との会合物
EP2289547B1 (en) 2003-09-12 2015-12-16 Agenus Inc. Vaccine for treatment and prevention of herpes simplex virus infection
US7425539B2 (en) 2004-03-19 2008-09-16 Baxter International Inc. Factor IXa for the treatment of bleeding disorders
JP2008509226A (ja) 2004-05-24 2008-03-27 ジェンボールト コーポレイション 回収可能な形式での安定なタンパク質保管および安定な核酸保管
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
EP2114379A2 (en) * 2006-12-20 2009-11-11 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
AU2008340304B2 (en) * 2007-12-21 2016-03-03 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
WO2009086400A2 (en) * 2007-12-28 2009-07-09 Baxter International Inc. Recombinant vwf formulations
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
DK2349314T3 (da) * 2008-10-21 2013-05-27 Baxter Int Lyofiliserede præparater af rekombinant VWF
EP2385825B1 (en) 2008-11-07 2018-10-10 University of Connecticut Factor viii formulations
JP5796860B2 (ja) 2009-12-22 2015-10-21 ライフボンド リミテッドＬｉｆｅｂｏｎｄ Ｌｔｄ 架橋マトリックスの特性を調節するための酵素的架橋剤の改変
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
CN105899220B (zh) * 2013-12-19 2020-01-10 扬森疫苗与预防公司 改进的病毒体配制品
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
EP3294324A1 (en) 2015-05-13 2018-03-21 Agenus Inc. Vaccines for treatment and prevention of cancer
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
KR20210005646A (ko) 2018-04-26 2021-01-14 아게누스 인코포레이티드 열쇼크 단백질-결합 펩티드 조성물 및 그의 이용 방법
US11998654B2 (en) 2018-07-12 2024-06-04 Bard Shannon Limited Securing implants and medical devices
KR20220029733A (ko) 2019-07-04 2022-03-08 체에스엘 베링 렝나우 아게 응고 인자 viii의 시험관내 안정성을 증가시키기 위한 절단된 폰 빌레브란트 인자 (vwf)
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
WO2024102796A2 (en) * 2022-11-08 2024-05-16 University Of Wyoming Stabilization of biologics and human blood clotting factor viii in a dry state

Family Cites Families (21)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
IL74909A (en) 1984-04-20 1992-01-15 Genentech Inc Preparation of functional human factor viii and dna sequences,expression vectors,transformed microorganisms and cell lines used therein
EP0182448A3 (en) 1984-08-24 1987-10-28 Genetics Institute, Inc. Production of factor viii and related products
ATE68524T1 (de) * 1985-07-09 1991-11-15 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
AU650045B2 (en) * 1990-09-12 1994-06-09 Lifecell Corporation 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
AU7254894A (en) * 1993-07-23 1995-02-20 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
GB9501040D0 (en) * 1995-01-19 1995-03-08 Quadrant Holdings Cambridge Dried composition
US7253262B2 (en) * 1995-01-19 2007-08-07 Quandrant Drug Delivery Limited Dried blood factor composition comprising trehalose
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
US20090149388A1 (en) 2009-06-11
JP3898221B2 (ja) 2007-03-28
PT1308170E (pt) 2008-12-26
EP1308170A2 (en) 2003-05-07
EP0871476A1 (en) 1998-10-21
DK0871476T3 (da) 2003-11-10
US20020128207A1 (en) 2002-09-12
EP2258402A3 (en) 2011-01-05
DE69629209T2 (de) 2004-02-19
DE69637749D1 (de) 2008-12-24
EP1974741A1 (en) 2008-10-01
ATE245442T1 (de) 2003-08-15
DE69629209D1 (de) 2003-08-28
CN1152713C (zh) 2004-06-09
CA2210872A1 (en) 1996-07-25
ES2316658T3 (es) 2009-04-16
CA2671383A1 (en) 1996-07-25
EP1308170A3 (en) 2004-03-03
AU704317B2 (en) 1999-04-22
SI1308170T1 (sl) 2009-04-30
CA2210872C (en) 2009-09-08
GB9501040D0 (en) 1995-03-08
KR100417593B1 (ko) 2004-04-30
WO1996022107A1 (en) 1996-07-25
JPH11503719A (ja) 1999-03-30
AU4454096A (en) 1996-08-07
ES2202425T3 (es) 2004-04-01
CA2671383C (en) 2012-04-24
EP1308170B1 (en) 2008-11-12
EP2258402A2 (en) 2010-12-08
KR19980701500A (ko) 1998-05-15
US6649386B2 (en) 2003-11-18
ATE413885T1 (de) 2008-11-15
US7803911B2 (en) 2010-09-28
EP0871476B1 (en) 2003-07-23
DK1308170T3 (da) 2008-12-15
CN1179107A (zh) 1998-04-15

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