ES2202613T3 - Procedimiento de esterilizacion final de productos biologicos. - Google Patents

Procedimiento de esterilizacion final de productos biologicos.

Info

Publication number
ES2202613T3
ES2202613T3 ES97921969T ES97921969T ES2202613T3 ES 2202613 T3 ES2202613 T3 ES 2202613T3 ES 97921969 T ES97921969 T ES 97921969T ES 97921969 T ES97921969 T ES 97921969T ES 2202613 T3 ES2202613 T3 ES 2202613T3
Authority
ES
Spain
Prior art keywords
products
product
biologically active
parvovirus
temperature
Prior art date
Legal status (The legal status 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 status listed.)
Expired - Lifetime
Application number
ES97921969T
Other languages
English (en)
Spanish (es)
Inventor
Jaap Kampinga
Robert Alcock
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Quadrant Drug Delivery Ltd
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 ES2202613T3 publication Critical patent/ES2202613T3/es
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • 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
    • A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
    • A61L2/04—Heat
    • 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
    • A61L2/0011—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 physical methods
    • A61L2/0023—Heat
    • 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
    • C12N7/00—Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof
    • C12N7/04—Inactivation or attenuation; Producing viral sub-units
    • A61L2103/05—

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Genetics & Genomics (AREA)
  • Biomedical Technology (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Organic Chemistry (AREA)
  • Zoology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Wood Science & Technology (AREA)
  • Biochemistry (AREA)
  • Microbiology (AREA)
  • Biotechnology (AREA)
  • Virology (AREA)
  • Molecular Biology (AREA)
  • General Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)
  • Meat, Egg Or Seafood Products (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Food Preservation Except Freezing, Refrigeration, And Drying (AREA)
  • Agricultural Chemicals And Associated Chemicals (AREA)
  • Peptides Or Proteins (AREA)
  • Enzymes And Modification Thereof (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
ES97921969T 1996-05-14 1997-05-14 Procedimiento de esterilizacion final de productos biologicos. Expired - Lifetime ES2202613T3 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US647515 1996-05-14
US08/647,515 US6632648B1 (en) 1996-05-14 1996-05-14 Methods of terminal sterilization of fibrinogen

Publications (1)

Publication Number Publication Date
ES2202613T3 true ES2202613T3 (es) 2004-04-01

Family

ID=24597275

Family Applications (1)

Application Number Title Priority Date Filing Date
ES97921969T Expired - Lifetime ES2202613T3 (es) 1996-05-14 1997-05-14 Procedimiento de esterilizacion final de productos biologicos.

Country Status (14)

Country Link
US (3) US6632648B1 (show.php)
EP (1) EP0914166B1 (show.php)
JP (1) JP4841018B2 (show.php)
AT (1) ATE245455T1 (show.php)
AU (1) AU730931B2 (show.php)
BR (1) BR9709082A (show.php)
CA (1) CA2254914C (show.php)
DE (1) DE69723703T2 (show.php)
DK (1) DK0914166T3 (show.php)
ES (1) ES2202613T3 (show.php)
NZ (1) NZ333212A (show.php)
PT (1) PT914166E (show.php)
WO (1) WO1997042980A1 (show.php)
ZA (1) ZA974179B (show.php)

Families Citing this family (38)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6632648B1 (en) * 1996-05-14 2003-10-14 Elan Drug Delivery Limited Methods of terminal sterilization of fibrinogen
US6627426B2 (en) 1997-02-14 2003-09-30 Invitrogen Corporation Methods for reducing adventitious agents and toxins and cell culture reagents produced thereby
US6383810B2 (en) 1997-02-14 2002-05-07 Invitrogen Corporation Dry powder cells and cell culture reagents and methods of production thereof
JP2002519009A (ja) * 1998-06-30 2002-07-02 インビトロゲン・コーポレーション 外来性因子および毒素を減弱するための方法ならびにそれにより産生される細胞培養試薬。
BR9905867A (pt) * 1998-11-06 2001-01-23 Bio Sidus S A Linhagem celular produtora de eritropoietina humana recombinante e a eritropoietina humana recombinante produzida por esta célula
CN101810854A (zh) 1999-02-22 2010-08-25 巴克斯特国际公司 新的无白蛋白的因子viii制剂
JP4493769B2 (ja) * 1999-12-21 2010-06-30 旭化成ケミカルズ株式会社 球形顆粒
EP1372727B1 (en) * 2001-04-04 2010-09-01 DelSiTech Oy Biodegradable carrier and method for preparation thereof
ES2403357T3 (es) 2003-12-11 2013-05-17 Isto Technologies Inc. Sistema de cartílago particulado
MXPA06013633A (es) 2004-05-27 2007-03-23 Baxter Int Inactivacion de un patogeno en una muestra a traves de un tratamiento con formalina y luz ultravioleta.
AU2005295368B2 (en) * 2004-10-20 2011-06-09 Ethicon, Inc. A reinforced absorbable multilayered hemostatic wound dressing and method of making
RU2413532C2 (ru) 2005-07-29 2011-03-10 Зольвай Фармасьютиклз Гмбх Способ получения стерилизованного порошкообразного панкреатина
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
US8480757B2 (en) 2005-08-26 2013-07-09 Zimmer, Inc. Implants and methods for repair, replacement and treatment of disease
US8182840B2 (en) 2005-09-27 2012-05-22 Tissue Tech, Inc. Amniotic membrane preparations and purified compositions and therapy for scar reversal and inhibition
US8187639B2 (en) 2005-09-27 2012-05-29 Tissue Tech, Inc. Amniotic membrane preparations and purified compositions and anti-angiogenesis treatment
PL2027263T3 (pl) * 2006-05-22 2013-01-31 Abbott Laboratories Gmbh Sposób separacji i określenia wiremii w próbce pankreatyny
US10072256B2 (en) 2006-05-22 2018-09-11 Abbott Products Gmbh Process for separating and determining the viral load in a pancreatin sample
US8163549B2 (en) 2006-12-20 2012-04-24 Zimmer Orthobiologics, Inc. Method of obtaining viable small tissue particles and use for tissue repair
CA2684040C (en) 2007-04-12 2016-12-06 Isto Technologies, Inc. Method of forming an implant using a mold that mimics the shape of the tissue defect site and implant formed therefrom
US20120177610A1 (en) * 2007-09-19 2012-07-12 Kieu Hoang Manufacturing and Purification Processes of Complex Protein found in Fraction IV to make a separated Apo, Transferrin , and Alpha 1 Anti strepsin (A1AT) or A combined Transferrin / Apo/Human Albumin/A1AT and all new found proteins
BRPI0921429B1 (pt) 2008-11-07 2022-07-12 Takeda Pharmaceutical Company Limited Formulação farmacêutica liofilizada estável, e, método para preparar um fator liofilizado estável
US9827205B2 (en) * 2008-12-12 2017-11-28 Mallinckrodt Pharma Ip Trading D.A.C. Dry powder fibrin sealant
EP2236617A1 (en) 2009-03-31 2010-10-06 Leukocare Ag Methods of terminal sterilization of biofunctional compositions
EP2593144A1 (en) * 2010-07-13 2013-05-22 Cephalon, Inc. Improved methods for the sterilization of bendamustine
WO2012149486A1 (en) 2011-04-28 2012-11-01 Tissuetech, Inc. Methods of modulating bone remodeling
EP2717888B1 (en) 2011-06-10 2020-09-09 Tissuetech, Inc. Methods of processing fetal support tissues
CN103874762A (zh) 2011-08-26 2014-06-18 组织技术公司 胎儿支持组织的灭菌方法
EP2771029A4 (en) 2011-10-25 2015-07-01 Onclave Therapeutics Ltd ANTIBODY FORMULATIONS AND METHOD THEREFOR
AU2013240916B2 (en) * 2012-03-31 2016-10-27 Waseda University Method for treating biological tissue and biological tissue
WO2014011813A1 (en) 2012-07-11 2014-01-16 Tissuetech, Inc. Compositions containing hc-ha/ptx3 complexes and methods of use thereof
US20140178343A1 (en) 2012-12-21 2014-06-26 Jian Q. Yao Supports and methods for promoting integration of cartilage tissue explants
TW201603818A (zh) 2014-06-03 2016-02-01 組織科技股份有限公司 組成物及方法
TW201642914A (zh) 2015-02-23 2016-12-16 組織科技股份有限公司 用於治療眼部疾病及失調的裝置及方法
CN107847526A (zh) 2015-05-20 2018-03-27 组织技术公司 用于预防上皮细胞的增殖和上皮‑间充质转换的组合物和方法
TW201733600A (zh) 2016-01-29 2017-10-01 帝聖工業公司 胎兒扶持組織物及使用方法
AU2022327637A1 (en) 2021-08-13 2024-01-18 Biotest Ag Fibrinogen compositions and methods of preparation

Family Cites Families (77)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3557717A (en) 1968-05-17 1971-01-26 Gen Mills Inc Process for making candy floss
US3619294A (en) 1968-07-15 1971-11-09 Penick & Ford Ltd Method of combining crystalline sugar with impregnating agents and products produced thereby
US3632357A (en) 1969-07-29 1972-01-04 Standard Brands Inc Method of producing hard candy
US3655442A (en) 1969-08-27 1972-04-11 California & Hawaiian Sugar Method of making sugar and sugar products
DE2246013A1 (de) 1972-09-20 1974-03-28 Boehringer Mannheim Gmbh Verfahren zur herstellung von poroesen tabletten
US4127502A (en) 1977-06-10 1978-11-28 Eastman Kodak Company Stabilizers for reconstituted, lyophilized samples
LU78955A1 (de) 1978-01-27 1979-09-06 Chimicasa Gmbh Verfahren zur inaktivierung von viren
US4158544A (en) 1978-07-17 1979-06-19 Beckman Instruments, Inc. Process for preparing a biological composition for use as a reference control in diagnostic analysis
US4588744A (en) 1978-09-19 1986-05-13 Mchugh John E Method of forming an aqueous solution of 3-3-Bis(p-hydroxyphenyl)-phthalide
FR2442554A1 (fr) 1978-11-24 1980-06-20 Thomson Brandt Commutateur electronique a commande tactile, et selecteur de canaux comportant un tel commutateur
US4440679A (en) * 1980-03-05 1984-04-03 Cutter Laboratories, Inc. Pasteurized therapeutically active protein compositions
EP0035204B2 (en) * 1980-03-05 1991-05-22 Miles Inc. Pasteurized therapeutically active protein compositions
US4294826A (en) 1980-05-07 1981-10-13 Armour Pharmaceutical Company Process for the preparation of highly purified antihemophilic factor
US4327076A (en) 1980-11-17 1982-04-27 Life Savers, Inc. Compressed chewable antacid tablet and method for forming same
JPS57140724A (en) 1981-02-25 1982-08-31 Green Cross Corp:The Heat-treatment of aqueous solution containing cold insoluble globulin
US4327077A (en) 1981-05-29 1982-04-27 Life Savers, Inc. Compressed chewable antacid tablet and method for forming same
US4879280A (en) 1981-09-24 1989-11-07 Fresenius Ag Dialysis solution for use in intraperitoneal dialysis
US4456590B2 (en) 1981-11-02 1989-05-30 Heat treatment of lyphilized blood clotting factor viii concentrate
US4994438A (en) 1981-11-02 1991-02-19 Cedars Sinai Medical Center Heat treatment of lyophilized plasma fractions
JPS58216695A (ja) 1982-06-07 1983-12-16 Otsuka Shokuhin Kogyo Kk トレハロ−スの製造方法
US4457916A (en) * 1982-08-31 1984-07-03 Asahi Kasei Kogyo Kabushiki Kaisha Method for stabilizing Tumor Necrosis Factor and a stable aqueous solution or powder containing the same
US4883762A (en) 1983-06-06 1989-11-28 Ciba Corning Diagnostics Corp. Stabilized isoenzyme control products
US4865871A (en) 1983-08-23 1989-09-12 Board Of Regents The University Of Texas System Method for cryopreparing biological tissue
US4490361A (en) 1983-12-02 1984-12-25 Alpha Therapeutic Corporation Virus inactivating heat treatment of plasma fractions
AT389815B (de) 1984-03-09 1990-02-12 Immuno Ag Verfahren zur inaktivierung von vermehrungsfaehigen filtrierbaren krankheitserregern in blutprodukten
JPS60258195A (ja) 1984-06-05 1985-12-20 Ss Pharmaceut Co Ltd α．α―トレハロース脂肪酸ジエステル誘導体
DE3434472A1 (de) 1984-09-20 1986-03-27 Lentia GmbH Chem. u. pharm. Erzeugnisse - Industriebedarf, 8000 München Verfahren zur pasteurisation von plasmaproteinen bzw. von plasmaproteinfraktionen
DE3445010A1 (de) 1984-12-10 1986-06-19 Boehringer Mannheim Gmbh Kontroll- bzw. eichserum fuer die lipid-diagnostik
US4677195A (en) 1985-01-11 1987-06-30 Genetics Institute, Inc. Method for the purification of erythropoietin and erythropoietin compositions
GB8505882D0 (en) 1985-03-07 1985-04-11 Central Blood Lab Authority Purification of blood coagulation factor viii
GB8508173D0 (en) 1985-03-28 1985-05-01 Standard Telephones Cables Ltd Controlled delivery device
EP0229810B1 (en) 1985-07-09 1991-10-16 Quadrant Bioresources Limited Protection of proteins and the like
US4758657A (en) 1985-07-11 1988-07-19 Armour Pharmaceutical Company Method of purifying Factor VIII:C
ATE52922T1 (de) 1985-08-05 1990-06-15 Immuno Ag Verfahren zur herstellung von praeparationen auf basis von blutgerinnungsfaktoren.
CA1276563C (en) 1985-09-30 1990-11-20 Stanley E. Charm High temperature, short time heating system and method of sterilizing heat-sensitive biological fluids
JPS62228024A (ja) * 1985-11-30 1987-10-06 Green Cross Corp:The 免疫グロブリンの加熱処理方法
EP0225581A3 (en) * 1985-11-30 1989-05-24 Green Cross Corporation Method for the heat-treatment of immunoglobulins and immunoglobulin product
JPS62174094A (ja) 1985-12-16 1987-07-30 Ss Pharmaceut Co Ltd α．α―トレハロース誘導体
GB8604983D0 (en) 1986-02-28 1986-04-09 Biocompatibles Ltd Protein preservation
JPH0662436B2 (ja) 1986-05-19 1994-08-17 株式会社ミドリ十字 静注用免疫グロブリン製剤の製造方法
US4762857A (en) 1986-05-30 1988-08-09 E. I. Du Pont De Nemours And Company Trehalose as stabilizer and tableting excipient
US4749783A (en) 1986-07-11 1988-06-07 Miles Laboratories, Inc. Viral inactivation and purification of active proteins
FR2604157B1 (fr) 1986-09-18 1989-09-01 Air Liquide Structure isotherme
NL8700484A (nl) 1987-02-26 1988-09-16 Victor George Ryhiner Vriesdroogkamer volgens een modulerende directe expansie principe.
US5118795A (en) * 1987-05-15 1992-06-02 University Of Southern California Sequential heat treatment of blood-clotting factor products
US5097018A (en) 1988-05-12 1992-03-17 University Of Southern California Sequential heat treatment of blood-clotting factor products
US5099002A (en) 1987-05-15 1992-03-24 University Of Southern California Sequential improved method for treatment of human blood-clotting factor products
JP2545231B2 (ja) 1987-06-18 1996-10-16 日本ケミカルリサ−チ株式会社 ウロキナ−ゼの加熱による低分子化抑制法
GB8715238D0 (en) 1987-06-29 1987-08-05 Quadrant Bioresources Ltd Food process
US4909940A (en) 1987-12-30 1990-03-20 New York Blood Center, Inc. Extraction of process chemicals from labile biological mixtures with organic alcohols or with halogenated hydrocarbons
GB8801338D0 (en) 1988-01-21 1988-02-17 Quadrant Bioresources Ltd Preservation of viruses
US5045446A (en) 1988-08-26 1991-09-03 Cryopharm Corporation Lyophilization of cells
AU5414990A (en) 1989-04-12 1990-11-05 Aberdeen University Slow release vitreous systems
DE69002033T2 (de) 1989-05-24 1993-09-30 Miles Inc Gelfiltration von wärmebehandeltem Faktor VIII.
GB8917470D0 (en) 1989-07-31 1989-09-13 Quadrant Bioresources Ltd Composition and method
US5418130A (en) 1990-04-16 1995-05-23 Cryopharm Corporation Method of inactivation of viral and bacterial blood contaminants
IT1246350B (it) 1990-07-11 1994-11-17 Eurand Int Metodo per ottenere una rapida sospensione in acqua di farmaci insolubili
JPH06500632A (ja) 1990-08-10 1994-01-20 アナリティカル・コントロール・システムズ・インコーポレーテッド 改良された診断および治療組成物
US5200399A (en) 1990-09-14 1993-04-06 Boyce Thompson Institute For Plant Research, Inc. Method of protecting biological materials from destructive reactions in the dry state
EP0551457B1 (de) 1991-07-31 1995-08-09 Farros Blatter Ag Schleifgerät zum schleifen einer zylindrischen oder sphärischen oberfläche einer walze, insbesondere einer walze einer papiermaschine
GB9125695D0 (en) 1991-12-03 1992-01-29 Mastavac Limited Medical preparations
DE69212497T2 (de) 1991-12-05 1996-12-12 Mallinckrodt Veterinary, Inc., Mundelein, Ill. Glasartige kohlenhydratenmatrize zur verabreichung von heilmitteln mit verzögerter wirkstoffabgabe
US5192743A (en) 1992-01-16 1993-03-09 Genentech, Inc. Reconstitutable lyophilized protein formulation
IT1254359B (it) * 1992-05-11 1995-09-14 Serono Cesare Ist Ricerca Composizioni farmaceutiche contenenti il-6
JP3182564B2 (ja) 1992-08-24 2001-07-03 味の素ファルマ株式会社 栄養組成物
US5422384A (en) 1992-11-25 1995-06-06 Battelle Memorial Institute Glass/polymer composites and methods of making
JP3168550B2 (ja) 1992-12-02 2001-05-21 株式会社林原生物化学研究所 脱水剤およびそれを用いる含水物の脱水方法並びにその方法で得られる脱水物品
ATE197550T1 (de) 1993-02-23 2000-12-15 Genentech Inc Stabilisierung von mit organischen lösungsmittel behandelten polypeptiden mit einem hilfsstoff
AU4953393A (en) 1993-08-24 1995-03-21 Mogen International N.V. Production of trehalose in plants
ES2194911T3 (es) 1994-06-02 2003-12-01 Elan Drug Delivery Ltd Metodo para evitar la agregacion de proteinas/peptidos cuando tiene lugar su rehidratacion o descongelacion.
EP0699687B1 (en) 1994-08-31 2004-01-28 Mitsubishi Pharma Corporation Process for purifying recombinant human serum albumin
US5512547A (en) 1994-10-13 1996-04-30 Wisconsin Alumni Research Foundation Pharmaceutical composition of botulinum neurotoxin and method of preparation
JPH08157491A (ja) 1994-11-30 1996-06-18 Hayashibara Biochem Lab Inc トレハロース誘導体の製造方法
GB9501040D0 (en) * 1995-01-19 1995-03-08 Quadrant Holdings Cambridge Dried composition
US6267958B1 (en) * 1995-07-27 2001-07-31 Genentech, Inc. Protein formulation
DE19528221C2 (de) * 1995-08-01 1998-10-22 Blutspendedienst Der Drk Lande Verfahren zur Herstellung eines virussicheren, therapeutischen Präparates aus Humanplasma
US6632648B1 (en) * 1996-05-14 2003-10-14 Elan Drug Delivery Limited Methods of terminal sterilization of fibrinogen

Also Published As

Publication number Publication date
AU730931B2 (en) 2001-03-22
JP4841018B2 (ja) 2011-12-21
US20030211592A1 (en) 2003-11-13
PT914166E (pt) 2003-12-31
WO1997042980A1 (en) 1997-11-20
JP2000511519A (ja) 2000-09-05
AU2784597A (en) 1997-12-05
BR9709082A (pt) 2001-11-27
NZ333212A (en) 2000-05-26
EP0914166B1 (en) 2003-07-23
ATE245455T1 (de) 2003-08-15
ZA974179B (en) 1997-12-10
DK0914166T3 (da) 2003-11-10
US6632648B1 (en) 2003-10-14
US20070249033A1 (en) 2007-10-25
CA2254914A1 (en) 1997-11-20
EP0914166A1 (en) 1999-05-12
DE69723703D1 (de) 2003-08-28
CA2254914C (en) 2008-07-29
DE69723703T2 (de) 2004-01-29

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