BR0312522A - Método para a preparação de trombina inativada por vìrus, trombina, formulação farmacêutica, e, kit farmacêutico - Google Patents

Método para a preparação de trombina inativada por vìrus, trombina, formulação farmacêutica, e, kit farmacêutico

Info

Publication number
BR0312522A
BR0312522A BR0312522-0A BR0312522A BR0312522A BR 0312522 A BR0312522 A BR 0312522A BR 0312522 A BR0312522 A BR 0312522A BR 0312522 A BR0312522 A BR 0312522A
Authority
BR
Brazil
Prior art keywords
thrombin
preparation
pharmaceutical
virus inactivated
pharmaceutical formulation
Prior art date
Application number
BR0312522-0A
Other languages
English (en)
Other versions
BRPI0312522B1 (pt
BRPI0312522B8 (pt
Inventor
Caroline Connolly
Christopher Hardway
David Evans
Peter Feldman
Original Assignee
Nat Blood Authority
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 Nat Blood Authority filed Critical Nat Blood Authority
Publication of BR0312522A publication Critical patent/BR0312522A/pt
Publication of BRPI0312522B1 publication Critical patent/BRPI0312522B1/pt
Publication of BRPI0312522B8 publication Critical patent/BRPI0312522B8/pt

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/14—Hydrolases (3)
    • C12N9/48—Hydrolases (3) acting on peptide bonds (3.4)
    • C12N9/50—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25)
    • C12N9/64—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue
    • C12N9/6421—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue from mammals
    • C12N9/6424—Serine endopeptidases (3.4.21)
    • C12N9/6429—Thrombin (3.4.21.5)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/0005—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
    • A61L2/0082—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts using chemical substances
    • A61L2/0088—Liquid substances
    • 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
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y304/00—Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
    • C12Y304/21—Serine endopeptidases (3.4.21)
    • C12Y304/21005—Thrombin (3.4.21.5)

Abstract

"MéTODO PARA A PREPARAçãO DE TROMBINA INATIVADA POR VìRUS, TROMBINA, FORMULAçãO FARMACêUTICA, E, KIT FARMACêUTICO". Um método para a preparação de trombina inativada por vírus compreendendo a inativação de vírus por solvente-detergente de uma solução compreendendo protrombina e fator X, o carregamento de fator X e protrombina inativada por vírus para cima de um meio de troca aniónica, a lavagem do meio para recuperar os reagentes usados para a inativação de vírus por solvente-detergente, e a ativação da protrombina sobre o meio para formar trombina pela adição de íons de metal, preferivelmente íons de cálcio. A trombina é então preferivelmente seletivamente eluída do meio de troca aniónica.
BRPI0312522A 2002-07-10 2003-07-07 método para a preparação de trombina vírus-inativada BRPI0312522B8 (pt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GBGB0216002.6A GB0216002D0 (en) 2002-07-10 2002-07-10 Process and composition
PCT/GB2003/002942 WO2004007707A1 (en) 2002-07-10 2003-07-07 Process for producing a virus-inactivated thrombin preparation

Publications (3)

Publication Number Publication Date
BR0312522A true BR0312522A (pt) 2005-04-19
BRPI0312522B1 BRPI0312522B1 (pt) 2019-01-02
BRPI0312522B8 BRPI0312522B8 (pt) 2021-05-25

Family

ID=9940204

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI0312522A BRPI0312522B8 (pt) 2002-07-10 2003-07-07 método para a preparação de trombina vírus-inativada

Country Status (19)

Country Link
US (1) US8435779B2 (pt)
EP (1) EP1520018B1 (pt)
JP (1) JP4445386B2 (pt)
AT (1) ATE354648T1 (pt)
AU (1) AU2003244858B2 (pt)
BR (1) BRPI0312522B8 (pt)
CA (1) CA2491718C (pt)
CY (1) CY1107632T1 (pt)
DE (1) DE60311990T2 (pt)
EC (1) ECSP055586A (pt)
ES (1) ES2282644T3 (pt)
GB (1) GB0216002D0 (pt)
IL (3) IL165989A0 (pt)
MX (1) MXPA05000393A (pt)
NO (1) NO20050090L (pt)
NZ (1) NZ537502A (pt)
PL (1) PL208219B1 (pt)
PT (1) PT1520018E (pt)
WO (1) WO2004007707A1 (pt)

Families Citing this family (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
NZ552680A (en) * 2004-06-29 2010-03-26 Reliance Life Sciences Pvt Ltd Process for the preparation of virus-safe biological fluids
EP1685852A1 (en) * 2005-02-01 2006-08-02 Fondation pour la Recherche Diagnostique Set of disposable bags for viral inactivation of biological fluids
US20060270015A1 (en) * 2005-05-26 2006-11-30 Dan Pawlak Thrombin purification
WO2007014896A1 (en) 2005-07-29 2007-02-08 Solvay Pharmaceuticals Gmbh Processes for the manufacture of sterilized pancreatin powder
US9198871B2 (en) 2005-08-15 2015-12-01 Abbott Products Gmbh Delayed release pancreatin compositions
US11266607B2 (en) 2005-08-15 2022-03-08 AbbVie Pharmaceuticals GmbH Process for the manufacture and use of pancreatin micropellet cores
CA2653127C (en) * 2006-05-22 2015-09-15 Solvay Pharmaceuticals Gmbh Process for separating and determining the viral load in a pancreatin sample
US10072256B2 (en) 2006-05-22 2018-09-11 Abbott Products Gmbh Process for separating and determining the viral load in a pancreatin sample
US7774628B2 (en) * 2006-05-25 2010-08-10 Foundry Networks, Inc. Enabling/disabling power-over-ethernet software subsystem in response to power supply status
CA2721335A1 (en) * 2008-04-16 2009-10-22 Ryoichi Kawamura Process for preparing bioabsorbable sheet preparation holding thrombin
JP5442310B2 (ja) * 2009-04-23 2014-03-12 旭化成メディカル株式会社 トロンビン溶液の調製方法
AU2015252061A1 (en) * 2009-07-31 2015-11-19 Baxalta GmbH Method for Purifying Recombinant ADAMTS13 and Other Proteins and Compositions Thereof
US8945895B2 (en) * 2009-07-31 2015-02-03 Baxter International Inc. Methods of purifying recombinant ADAMTS13 and other proteins and compositions thereof
SE1050124A1 (sv) * 2010-02-08 2011-08-09 Linkoping Biocontrols Ab Stabil lösning
CN102357259A (zh) * 2011-07-28 2012-02-22 王珊珊 一种生物蛋白海绵及其制备方法
EP2855504B1 (en) * 2012-05-31 2018-10-24 Agency For Science, Technology And Research Chromatographic purification of immunoglobulin g preparations with particles having multimodal functionalities
US9932388B2 (en) 2014-11-13 2018-04-03 Hemarus Therapeutics Limited Chromatographic process for producing high purity fibrinogen and thrombin
CN113754757A (zh) * 2021-07-01 2021-12-07 华兰生物工程股份有限公司 一种人纤维蛋白原的制备方法

Family Cites Families (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3336631A1 (de) * 1983-10-08 1985-04-18 Behringwerke Ag, 3550 Marburg Verfahren zur pasteurisierung von plasma oder von konzentraten der blutgerinnungsfaktoren ii, vii, ix und x
DE3843126C3 (de) 1988-12-22 1994-10-06 Octapharma Ag Verfahren zur Herstellung eines hochreinen Thrombinkonzentrates
IE73210B1 (en) * 1990-01-24 1997-05-07 Warner Lambert Co Process for the production of thrombin and high purity thrombin preparation thereby obtained
EP0443724B1 (en) * 1990-02-20 1999-03-17 Baxter International Inc. Viral-safe purified human thrombin
FR2679251B1 (fr) 1991-07-18 1993-11-12 Nord Assoc Essor Transfusion San Procede de preparation d'un concentre de thrombine humaine destine a un usage therapeutique.
AT398079B (de) 1991-11-04 1994-09-26 Immuno Ag Präparation mit thrombinaktivität sowie verfahren zu ihrer herstellung
DE4137996A1 (de) * 1991-11-19 1993-05-27 Behringwerke Ag Verfahren zur herstellung eines virussicheren thrombinkonzentrates
AT397390B (de) * 1992-04-06 1994-03-25 Immuno Ag Verfahren zur spaltung von proteinen
GB9503750D0 (en) 1995-02-24 1995-04-12 Common Services Agency Thrombin preparation
AT500670A1 (de) * 1999-05-19 2006-02-15 Bio & Bio Licensing Sa Arzneimittel zur lokalen anwendung
US6245548B1 (en) * 2000-03-09 2001-06-12 American National Red Cross Activation of pure prothrombin to thrombin with about 30% to about 40% sodium citrate
DE10012732A1 (de) * 2000-03-18 2001-09-20 Aventis Behring Gmbh Thrombin-Zubereitungen und Verfahren zu ihrer Herstellung
IL136552A (en) 2000-06-05 2005-05-17 Omrix Biopharmaceuticals Ltd Method for the inactivation of viruses by a solvent - detergent combination and by nanofiltration
US20030133829A1 (en) * 2001-12-21 2003-07-17 Baxter Healthcare Corporation Process for inactivating pathogens in a biological material

Also Published As

Publication number Publication date
JP4445386B2 (ja) 2010-04-07
GB0216002D0 (en) 2002-08-21
IL165989A0 (en) 2006-01-15
JP2005532073A (ja) 2005-10-27
NZ537502A (en) 2007-12-21
EP1520018B1 (en) 2007-02-21
ES2282644T3 (es) 2007-10-16
US20060134769A1 (en) 2006-06-22
CA2491718A1 (en) 2004-01-22
AU2003244858B2 (en) 2008-01-31
IL201146A (en) 2011-05-31
ECSP055586A (es) 2005-07-06
DE60311990T2 (de) 2007-11-08
EP1520018A1 (en) 2005-04-06
PT1520018E (pt) 2007-04-30
PL208219B1 (pl) 2011-03-31
WO2004007707A1 (en) 2004-01-22
US8435779B2 (en) 2013-05-07
BRPI0312522B1 (pt) 2019-01-02
MXPA05000393A (es) 2005-07-22
PL374747A1 (en) 2005-10-31
CA2491718C (en) 2013-10-22
CY1107632T1 (el) 2013-04-18
ATE354648T1 (de) 2007-03-15
DE60311990D1 (de) 2007-04-05
IL165989A (en) 2010-11-30
BRPI0312522B8 (pt) 2021-05-25
NO20050090L (no) 2005-04-08
AU2003244858A1 (en) 2004-02-02

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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]
B25A Requested transfer of rights approved

Owner name: NHS BLOOD AND TRANSPLANT (GB)

B25A Requested transfer of rights approved

Owner name: BIO PRODUCTS LABORATORY LIMITED (GB)

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]
B07A Application suspended after technical examination (opinion) [chapter 7.1 patent gazette]
B09A Decision: intention to grant [chapter 9.1 patent gazette]
B16A Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]

Free format text: PRAZO DE VALIDADE: 10 (DEZ) ANOS CONTADOS A PARTIR DE 02/01/2019, OBSERVADAS AS CONDICOES LEGAIS.

B16C Correction of notification of the grant [chapter 16.3 patent gazette]

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B21F Lapse acc. art. 78, item iv - on non-payment of the annual fees in time

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