BRPI0412441A - método para estabilizar um crioprecipitado de proteìnas plasmáticas para ser submetido a um tratamento térmico de inativação viral - Google Patents

método para estabilizar um crioprecipitado de proteìnas plasmáticas para ser submetido a um tratamento térmico de inativação viral

Info

Publication number
BRPI0412441A
BRPI0412441A BRPI0412441-3A BRPI0412441A BRPI0412441A BR PI0412441 A BRPI0412441 A BR PI0412441A BR PI0412441 A BRPI0412441 A BR PI0412441A BR PI0412441 A BRPI0412441 A BR PI0412441A
Authority
BR
Brazil
Prior art keywords
stabilizing
proteins
viral inactivation
cryoprecipitate
heat treatment
Prior art date
Application number
BRPI0412441-3A
Other languages
English (en)
Inventor
Annie Bardat
Edith Begin
Original Assignee
Lab Francais Du Fractionnement
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 Lab Francais Du Fractionnement filed Critical Lab Francais Du Fractionnement
Publication of BRPI0412441A publication Critical patent/BRPI0412441A/pt

Links

Classifications

    • 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
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K38/363—Fibrinogen
    • 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
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/39—Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin, cold insoluble globulin [CIG]
    • 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
    • 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
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Zoology (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Hematology (AREA)
  • Biomedical Technology (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)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)

Abstract

"MéTODO PARA ESTABILIZAR UM CRIOPRECIPITADO DE PROTEìNAS PLASMáTICAS PARA SER SUBMETIDO A UM TRATAMENTO TéRMICO DE INATIVAçãO VIRAL". A presente invenção se refere a um método para obtenção de proteínas crioprecipitáveis, compreendendo uma etapa de inativação viral mediante tratamento térmico de um liofilizado dessas proteínas, compreendendo, antes de restituir as proteínas na forma de um liofilizado, uma etapa de adição inicial, a essas proteínas, de uma formulação de estabilização e solubilização contendo uma mistura consistindo em arginina, pelo menos um aminoácido hidrofóbico e citrato de sódio tribásico. A invenção também se refere a um concentrado consistindo em pelo menos uma proteína crioprecipitável contendo a formulação de estabilização e solubilização introduzida de acordo com o método e sendo adequada para uso terapêutico.
BRPI0412441-3A 2003-07-09 2004-07-08 método para estabilizar um crioprecipitado de proteìnas plasmáticas para ser submetido a um tratamento térmico de inativação viral BRPI0412441A (pt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR0308403A FR2857267B1 (fr) 2003-07-09 2003-07-09 Formulation stabilisante et solubilisante pour les proteines cryoprecipitables.
PCT/FR2004/001788 WO2005004901A1 (fr) 2003-07-09 2004-07-08 Procede de stabilisation d’un cryoprecipite de proteines plasmatiques destine a etre soumis a un traitement thermique d’inactivation virale

Publications (1)

Publication Number Publication Date
BRPI0412441A true BRPI0412441A (pt) 2006-09-05

Family

ID=33522899

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI0412441-3A BRPI0412441A (pt) 2003-07-09 2004-07-08 método para estabilizar um crioprecipitado de proteìnas plasmáticas para ser submetido a um tratamento térmico de inativação viral

Country Status (13)

Country Link
US (1) US7727743B2 (pt)
EP (1) EP1648496B1 (pt)
JP (2) JP4925822B2 (pt)
AT (1) ATE546155T1 (pt)
AU (1) AU2004255503B2 (pt)
BR (1) BRPI0412441A (pt)
CA (1) CA2531419C (pt)
DK (1) DK1648496T3 (pt)
ES (1) ES2382934T3 (pt)
FR (1) FR2857267B1 (pt)
IL (1) IL172844A (pt)
PL (1) PL1648496T3 (pt)
WO (1) WO2005004901A1 (pt)

Families Citing this family (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR100624013B1 (ko) * 2004-06-25 2006-09-19 주식회사 녹십자홀딩스 동결건조된 알부민 비함유 재조합 사람 혈액응고 제 8인자 제제
US20060019234A1 (en) * 2004-07-22 2006-01-26 Shanbrom Technologies, Llc Modern blood banking employing improved cell preservation composition
FR2874216B1 (fr) 2004-08-16 2006-11-03 Lab Francais Du Fractionnement Procede de preparation d'un concentre de facteur von willebrand (fvw) par voie chromatographique et concentre de fvw susceptible d'etre ainsi obtenu
FR2894831B1 (fr) * 2005-12-16 2008-02-15 Lab Francais Du Fractionnement Colle biologique exempte de thrombine et son utilisation comme medicament.
ES2264403B1 (es) * 2006-06-22 2007-11-01 Grifols S.A. Medio de suspension de hematies.
CA2692165A1 (en) 2007-06-25 2008-12-31 Amgen Inc. Compositions of specific binding agents to hepatocyte growth factor
US8349367B2 (en) * 2007-10-12 2013-01-08 Bakaltcheva Irina B Freeze-dried plasma formats for the trauma care field
FR2947181B1 (fr) 2009-06-26 2012-05-04 Lfb Biotechnologies Composition de facteur vii
TW201335181A (zh) * 2012-01-31 2013-09-01 Kieu Hoang ５５種新發現的蛋白質之序列及其應用
WO2018007767A1 (fr) * 2016-07-06 2018-01-11 Laboratoire Francais Du Fractionnement Et Des Biotechnologies Fibrinogène liquide stable
FR3053592B1 (fr) * 2016-07-06 2020-05-29 Laboratoire Francais Du Fractionnement Et Des Biotechnologies Fibrinogene liquide stable
FR3061020B1 (fr) * 2016-12-22 2019-05-17 Laboratoire Francais Du Fractionnement Et Des Biotechnologies Composition de fibrinogene humain
WO2019074886A1 (en) 2017-10-09 2019-04-18 Terumo Bct Biotechnologies, Llc LYOPHILIZATION CONTAINER AND METHOD OF USE
US11609043B2 (en) 2019-03-14 2023-03-21 Terumo Bct Biotechnologies, Llc Lyophilization container fill fixture, system and method of use
WO2023119277A1 (en) 2021-12-21 2023-06-29 Omrix Biopharmaceuticals Ltd. Highly soluble fibrinogen compositions

Family Cites Families (19)

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Publication number Priority date Publication date Assignee Title
US4623717A (en) * 1980-03-05 1986-11-18 Miles Laboratories, Inc. Pasteurized therapeutically active protein compositions
US4456590B2 (en) 1981-11-02 1989-05-30 Heat treatment of lyphilized blood clotting factor viii concentrate
DE3203775A1 (de) * 1982-02-04 1983-08-11 Behringwerke Ag, 3550 Marburg Fibrinogenzubereitung, verfahen zu ihrer herstellungund ihre verwendung
US4470968A (en) * 1983-01-13 1984-09-11 Miles Laboratories, Inc. Pasteurized therapeutically active blood coagulation factor concentrates
CA1260389A (en) 1984-10-10 1989-09-26 Jay A. Levy Human plasma, plasma fractions, and compositions thereof substantially free of infectious viruses, bacteria and retroviruses
JPS6289628A (ja) * 1985-09-11 1987-04-24 Green Cross Corp:The 人フイブリノゲン製剤の加熱処理法
DE3622642A1 (de) * 1986-07-05 1988-01-14 Behringwerke Ag Einkomponenten-gewebekleber sowie verfahren zu seiner herstellung
JPS6419023A (en) * 1987-04-21 1989-01-23 Green Cross Corp Heat treatment of fibrinogen and fibrinogen preparation
DE3729863A1 (de) * 1987-09-05 1989-03-16 Boehringer Mannheim Gmbh Stabilisierte erythropoietin-lyophilisate
FR2632309B1 (fr) 1988-06-07 1990-08-24 Lille Transfusion Sanguine Procede de purification par voie chromatographique de proteines, notamment de facteur viii, et les produits obtenus
AU670793B2 (en) * 1992-04-30 1996-08-01 Alpha Therapeutic Corporation Improved solubilization and stabilization of factor VIII complex
DE4242863A1 (de) * 1992-12-18 1994-06-23 Boehringer Mannheim Gmbh Stabile lyophilisierte pharmazeutische Zubereitungen von G-CSF
GB9424732D0 (en) * 1994-12-08 1995-02-08 Common Services Agency Heat treated blood plasma proteins
AUPO871997A0 (en) * 1997-08-25 1997-09-18 Csl Limited Dried biologically or therapeutically active preparations
DK1018345T3 (da) * 1998-06-26 2009-03-23 Otsuka Pharma Co Ltd Vandoplöselige, törre sammensætninger
JP2000247903A (ja) * 1999-03-01 2000-09-12 Chugai Pharmaceut Co Ltd 長期安定化製剤
JP2001270900A (ja) * 2000-03-23 2001-10-02 Nihon Pharmaceutical Co Ltd フィブリノゲンのウイルス不活化法
US6623717B2 (en) 2001-03-28 2003-09-23 Council Of Scientific And Industrial Research Process for the preparation of LiBF4
JP2003055257A (ja) * 2001-08-10 2003-02-26 Nihon Pharmaceutical Co Ltd 安定な血液凝固第ｘｉｉｉ因子製剤

Also Published As

Publication number Publication date
ATE546155T1 (de) 2012-03-15
US20060247426A1 (en) 2006-11-02
JP2012051895A (ja) 2012-03-15
JP4925822B2 (ja) 2012-05-09
CA2531419A1 (fr) 2005-01-20
FR2857267A1 (fr) 2005-01-14
CA2531419C (fr) 2014-12-23
WO2005004901A1 (fr) 2005-01-20
JP5719266B2 (ja) 2015-05-13
AU2004255503B2 (en) 2010-12-16
ES2382934T3 (es) 2012-06-14
EP1648496B1 (fr) 2012-02-22
EP1648496A1 (fr) 2006-04-26
IL172844A0 (en) 2006-06-11
PL1648496T3 (pl) 2012-07-31
AU2004255503A1 (en) 2005-01-20
FR2857267B1 (fr) 2006-03-10
US7727743B2 (en) 2010-06-01
DK1648496T3 (da) 2012-05-07
IL172844A (en) 2011-11-30
JP2007516187A (ja) 2007-06-21

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Legal Events

Date Code Title Description
B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]
B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]

Free format text: NOTIFICACAO DE ANUENCIA RELACIONADA COM O ART 229 DA LPI

B06T Formal requirements before examination [chapter 6.20 patent gazette]
B06A Patent application procedure suspended [chapter 6.1 patent gazette]
B11B Dismissal acc. art. 36, par 1 of ipl - no reply within 90 days to fullfil the necessary requirements