NO323460B1 - Fremgangsmate til fremstilling i stor skala av en lagringsstabil trombinsammensetning med terapeutisk kvalitet som hovedsakelig er fri for virus - Google Patents

Fremgangsmate til fremstilling i stor skala av en lagringsstabil trombinsammensetning med terapeutisk kvalitet som hovedsakelig er fri for virus Download PDF

Info

Publication number
NO323460B1
NO323460B1 NO19971104A NO971104A NO323460B1 NO 323460 B1 NO323460 B1 NO 323460B1 NO 19971104 A NO19971104 A NO 19971104A NO 971104 A NO971104 A NO 971104A NO 323460 B1 NO323460 B1 NO 323460B1
Authority
NO
Norway
Prior art keywords
thrombin
approx
solution
stated
human
Prior art date
Application number
NO19971104A
Other languages
English (en)
Norwegian (no)
Other versions
NO971104D0 (no
NO971104L (no
Inventor
Trung Bui-Khac
Zbigniew Proba
Nicolas Dupuis
Teresa Brodniewics
Original Assignee
Haemacure Corp
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 Haemacure Corp filed Critical Haemacure Corp
Publication of NO971104D0 publication Critical patent/NO971104D0/no
Publication of NO971104L publication Critical patent/NO971104L/no
Publication of NO323460B1 publication Critical patent/NO323460B1/no

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
    • 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)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S435/00—Chemistry: molecular biology and microbiology
    • Y10S435/814—Enzyme separation or purification
    • Y10S435/815—Enzyme separation or purification by sorption

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Genetics & Genomics (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • General Health & Medical Sciences (AREA)
  • Biochemistry (AREA)
  • General Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Medicinal Chemistry (AREA)
  • Molecular Biology (AREA)
  • Biotechnology (AREA)
  • Microbiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Hematology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Diabetes (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Enzymes And Modification Thereof (AREA)
NO19971104A 1994-09-21 1997-03-11 Fremgangsmate til fremstilling i stor skala av en lagringsstabil trombinsammensetning med terapeutisk kvalitet som hovedsakelig er fri for virus NO323460B1 (no)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US08/309,583 US5506127A (en) 1994-09-21 1994-09-21 Therapeutic grade thrombin produced by chromatography
PCT/CA1995/000541 WO1996009376A1 (en) 1994-09-21 1995-09-21 Therapeutic grade thrombin production and products

Publications (3)

Publication Number Publication Date
NO971104D0 NO971104D0 (no) 1997-03-11
NO971104L NO971104L (no) 1997-04-24
NO323460B1 true NO323460B1 (no) 2007-05-14

Family

ID=23198815

Family Applications (1)

Application Number Title Priority Date Filing Date
NO19971104A NO323460B1 (no) 1994-09-21 1997-03-11 Fremgangsmate til fremstilling i stor skala av en lagringsstabil trombinsammensetning med terapeutisk kvalitet som hovedsakelig er fri for virus

Country Status (12)

Country Link
US (1) US5506127A (de)
EP (1) EP0782616B1 (de)
JP (1) JP3628703B2 (de)
AT (1) ATE315641T1 (de)
AU (1) AU711298B2 (de)
DE (1) DE69534749T2 (de)
DK (1) DK0782616T3 (de)
ES (1) ES2258264T3 (de)
NO (1) NO323460B1 (de)
PT (1) PT782616E (de)
RU (1) RU2144081C1 (de)
WO (1) WO1996009376A1 (de)

Families Citing this family (22)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE4137996A1 (de) * 1991-11-19 1993-05-27 Behringwerke Ag Verfahren zur herstellung eines virussicheren thrombinkonzentrates
DK83092D0 (da) * 1992-06-24 1992-06-24 Unes As Fremgangsmaade til udvinding af thrombin
US5795780A (en) * 1993-06-23 1998-08-18 Bristol-Myers Squibb Company Method of use of autologous thrombin blood fraction in a cell culture with keratinocytes
JPH07308190A (ja) * 1994-05-18 1995-11-28 Green Cross Corp:The トロンビンの製造方法
FI952196A0 (fi) * 1995-05-08 1995-05-08 Suomen Punainen Risti Veripalv Framstaellning av immunoglobulin
US5702715A (en) * 1995-10-27 1997-12-30 Drying Technology Reinforced biological sealants
WO2000062828A1 (en) * 1996-04-30 2000-10-26 Medtronic, Inc. Autologous fibrin sealant and method for making the same
US5981254A (en) * 1997-10-30 1999-11-09 Haemacure Corporation Process for producing thrombin from plasma
US6274090B1 (en) 1998-08-05 2001-08-14 Thermogenesis Corp. Apparatus and method of preparation of stable, long term thrombin from plasma and thrombin formed thereby
US6391609B1 (en) * 1998-10-07 2002-05-21 Sigma-Aldrich Co. Thromboplastin reagents and methods for preparing and using such reagents
US6472162B1 (en) 1999-06-04 2002-10-29 Thermogenesis Corp. Method for preparing thrombin for use in a biological glue
DE60032001T2 (de) * 1999-09-27 2007-05-31 Sysmex Corp. Verfahren zur stabilisierung von thrombin
DE10012732A1 (de) * 2000-03-18 2001-09-20 Aventis Behring Gmbh Thrombin-Zubereitungen und Verfahren zu ihrer Herstellung
ES2214967B1 (es) * 2003-03-06 2005-06-16 Probitas Pharma, S.A Procedimiento para la eliminacion de virus en soluciones de fibrinogeno y fibrinogeno obtenido por dicho procedimiento.
ES2226587B1 (es) * 2004-10-22 2005-12-16 Probitas Pharma, S.A. Composicion de trombina estable.
US20060270014A1 (en) * 2005-05-26 2006-11-30 Dan Pawlak Thrombin purification
AU2007264735B2 (en) * 2006-06-26 2012-11-08 Omrix Biopharmaceuticals Inc. Virus removal by nanofiltration
RU2457248C2 (ru) * 2010-06-09 2012-07-27 Общество с ограниченной ответственностью фирма "Технология-Стандарт" Способ промышленного получения тромбина
BR112013008738B1 (pt) * 2010-10-11 2017-12-19 Abbvie Bahamas Ltd. Method for purification of a protein
EP2793934B1 (de) * 2011-12-23 2017-08-23 Merz Pharma GmbH & Co. KGaA Neuartiges verfahren zur herstellung von di-ketten-proteinen zur verwendung bei menschen
JP6713479B2 (ja) * 2015-02-25 2020-06-24 オムリックス・バイオファーマシューティカルズ・リミテッドOmrix Biopharmaceuticals Ltd. トロンビン及びその分解ポリペプチドの精製及び定量化方法
CA3091348A1 (en) * 2018-02-19 2019-08-22 Bayer Healthcare Llc Modified filter membrane and method

Family Cites Families (23)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4083957A (en) * 1974-07-26 1978-04-11 Lang John L Process for the alteration of the sex-ratio of mammals
NL7602423A (nl) * 1976-03-08 1977-09-12 Leuven Res & Dev Vzw Bepaling van heparine in bloedplasma.
US4380511A (en) * 1981-08-12 1983-04-19 Miles Laboratories, Inc. Purification of bovine thrombin
US4540573A (en) * 1983-07-14 1985-09-10 New York Blood Center, Inc. Undenatured virus-free biologically active protein derivatives
US4696812A (en) * 1985-10-28 1987-09-29 Warner-Lambert Company Thrombin preparations
US4965203A (en) * 1987-01-28 1990-10-23 Warner-Lambert Company Purified thrombin preparations
JPS63243032A (ja) * 1987-03-27 1988-10-07 Green Cross Corp:The トロンビンの加熱処理方法
JPS6440433A (en) * 1987-08-05 1989-02-10 Green Cross Corp Aqueous liquid composition of thrombin
SU1527261A1 (ru) * 1988-03-21 1989-12-07 Институт Химической И Биологической Физики Ан Эсср Способ получени тромбина
JP2832835B2 (ja) * 1988-12-21 1998-12-09 旭化成工業株式会社 ウイルス除去方法
DE3843126C3 (de) * 1988-12-22 1994-10-06 Octapharma Ag Verfahren zur Herstellung eines hochreinen Thrombinkonzentrates
EP0378208B2 (de) * 1989-01-13 2003-01-15 Mitsubishi Pharma Corporation Verfahren zur Herstellung einer Protein enthaltenden Zusammensetzung
US5281528A (en) * 1989-12-18 1994-01-25 Warner-Lambert Company Process for purified thromboplastin for ultra-pure thrombin preparation
IE73210B1 (en) * 1990-01-24 1997-05-07 Warner Lambert Co Process for the production of thrombin and high purity thrombin preparation thereby obtained
ES2131504T3 (es) * 1990-02-20 1999-08-01 Baxter Int Trombina humana purificada viricamente segura.
JPH0813750B2 (ja) * 1990-03-01 1996-02-14 持田製薬株式会社 経口用トロンビン製剤
JP3127232B2 (ja) * 1990-03-08 2001-01-22 ウェルファイド株式会社 蛋白質製剤の製造法
JP3093821B2 (ja) * 1991-06-19 2000-10-03 旭化成工業株式会社 銅アンモニア法再生セルロース多孔性中空糸膜の製造方法
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
US5331092A (en) * 1992-11-06 1994-07-19 Coletica Process of preparation of collagen containing in major proportion insoluble collagen and collagen having high mechanical resistance and thermal stability obtained thereby
US5229172A (en) * 1993-01-19 1993-07-20 Medtronic, Inc. Modification of polymeric surface by graft polymerization
JP2003318980A (ja) * 2002-04-24 2003-11-07 Mitsubishi Electric Corp ショートパケット用伝送フォーマット並びにゲートウェイシステム

Also Published As

Publication number Publication date
NO971104D0 (no) 1997-03-11
EP0782616A1 (de) 1997-07-09
DK0782616T3 (da) 2006-05-22
AU711298B2 (en) 1999-10-07
JPH10505753A (ja) 1998-06-09
PT782616E (pt) 2006-05-31
AU3515195A (en) 1996-04-09
NO971104L (no) 1997-04-24
DE69534749T2 (de) 2006-11-02
ATE315641T1 (de) 2006-02-15
RU2144081C1 (ru) 2000-01-10
WO1996009376A1 (en) 1996-03-28
US5506127A (en) 1996-04-09
DE69534749D1 (de) 2006-04-06
ES2258264T3 (es) 2006-08-16
EP0782616B1 (de) 2006-01-11
JP3628703B2 (ja) 2005-03-16

Similar Documents

Publication Publication Date Title
RU2144081C1 (ru) Способ крупномасштабного производства устойчивой при хранении композиции тромбина терапевтической степени чистоты
US4877866A (en) Method of producing a virus safe, storage-stable, and intravenously tolerable immunoglobulin-G preparation
US5981254A (en) Process for producing thrombin from plasma
US4876241A (en) Stabilization of biological and pharmaceutical products during thermal inactivation of viral and bacterial contaminants
US4424206A (en) Process for heat treatment of aqueous solution containing cold insoluble globulin to inactivate hepatitis virus
US5639730A (en) Method of producing a virus-safe biological preparation
RU2000113224A (ru) Способ продуцирования в высокой степени вирусобезопасных компонентов для получения фибринового клея из пула плазмы человека
NO177188B (no) Fremgangsmåte for separering av humane eller animalske plasmaproteiner
US4749783A (en) Viral inactivation and purification of active proteins
RU97106349A (ru) Производство и продукты тромбина терапевтической степени чистоты
JP3471379B2 (ja) ヒトアンチトロンビン−iiiの調製方法
JPH06505494A (ja) Ix因子の調製
RU2006107533A (ru) Способ получения раствора альфа-1-антитрипсина
NO176234B (no) Fremgangsmåte for inaktivering av patogener i et biologisk eller et farmasöytisk materiale
US5907032A (en) Thrombin preparation
WO1998030230A1 (en) Protein-containing compositions and process for producing the same
CA2822229A1 (en) Caprylate viral deactivation
US5945103A (en) Process for producing thrombin
DK175644B1 (da) Fremgangsmåde til stabilisering af biologiske og farmaceutiske midler under inaktivering af virale og bakterielle kontaminanter
CA2228031A1 (en) Doubly virus-inactivated human blood plasma, blood plasma derivatives produced therefrom and method for their production
JPH0733799A (ja) 高比活性トロンビンおよびその製造方法
JPH04365481A (ja) トロンビンの製造法

Legal Events

Date Code Title Description
MM1K Lapsed by not paying the annual fees