Research Project of Pharma Division

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					21. PROPOSAL :                                      QLRT-1999-00811
CEL FACTORY AREA :                          3.1.3
EU CONTRIBUTION :                           1.366.751 Euro
DURATION :                                  36 months
TYPE:                                       Research project



     Comparison and Validation of Novel Pyrogen Tests Based on the
                       Human Fever Reaction

ABSTRACT:

Pyrogen testing is a crucial safety control of drugs as well as innovative high- tech products such as
medical, cellular therapies and species-specific agents (e.g. recombinant proteins). For most biologicals,
especially blood-derived drugs, the rabbit animal experiment represents still the method of choice
consuming hundreds of thousands animals in the EU per year. This test is laborious, expensive, raises
ethical concerns and can not be applied for some of the new products. In recent years, in Europe a number
of alternative cellular assays have been developed exploiting the human fever reaction, i.e. human
leukocytes release inflammatory mediators in the presence of pyrogenic contamination. The suggested
network brings together the most prominent test systems for trans-national comparison and subsequent
validation of the most promising models as an integrated goal-oriented problem solving approach.
PARTICIPANTS :

COORDINATOR:                                           Tel: 49-7531-884116
Dr Thomas Hartung                                      Fax: 49-7531-884117
Steinbeis-Center InPuT at the University of Konstanz   E-mail: thomas.hartung@uni-konstanz.de
78457 Konstanz, GERMANY

ASSOCIATED CONTRACTOR                                  Tel: 49-6032-994-221
Dr Susanne Berthold                                    Fax: 49-6032-994-204
DPC Biermann GmbH                                      E-mail: sberthold@dpc-biermann.de
Hohe Strasse 4-8
61231 Bad Nauheim, GERMANY

PARTNER 2:                                            Tel: 44-1707-654753
Dr Stephen Poole                                      Fax: 44-1707-646730
National Institute for Biological Standards & Control E-mail: spoole@nibsc.uk
Division of Endocrinology
Blanche Lane
South Mims, Potters Bar, Herts EN6 3QC, UNITED KINGDOM

PARTNER 3:                                             Tel: 49-6103-772665
Dr Thomas Montag-Lessing                               Fax: 49-6103-771250
Paul-Ehrlich-Institut                                  E-mail: month@pei.de
Diagnostics & Sterility
Paul-Ehrlich-Str. 51-59
63225 Langen, GERMANY


PARTNER 4:                                             Tel: 31-30-2749111
Dr A. Martin Gommer                                    Fax: 31-30-2744421
RIVM, National Institute of Public Health              E-mail: martin.gommer@rivm.nl
and the Environment
A. van Leeuwenhooklaan 9
3720 Bilthoven, THE NETHERLANDS

PARTNER 5:                                             Tel: 43-512-5073518
Dr Gabriele Werner-Felmayer                            Fax: 43-512-5072865
Institut für Medizinische Chemie & Biochemie           E-mail: gabriele.werner-felmayer@uibk.ac.at
Der Universität Innsbruck
Fritz-Pregl-Str. 3
6020 Innsbruck, AUSTRIA

PARTNER 6:                                             Tel: 41-31-6312502
Dr Thomas Jungi                                        Fax: 41-31-6312534
University of Bern                                     E-mail: thomas.jungi@ivv.unibe.ch
Institute of Veterinary Virology
Laenggass-Str. 122
3012 Bern, SWITZERLAND
PARTNER 7:                                            Tel: 41-61-6964984
Mr Peter Brügger                                      Fax: 41-61-6964309
Novartis Pharma AG                                    E-mail: peter.bruegger@pharma.novartis.com
Biological Analytics,
QA-WBA/BMS-W5J WKL-127.406
4002 Basel, SWITZERLAND

PARTNER 8:                                             Tel: 39-0332-789806
Dr Sandra Coecke                                       Fax: 39-0332-785336
ECVAM In Vitro Toxicology Laboratories                 E-mail: sandra.coecke@jrc.it
Quality/Metabolism/Neurotoxicity
European Center for the Validation of Alternative Methods
European Commission, Joint Research Center, MVMC Unit
21020 Ispra, ITALY

PARTNER 9:                                            Tel: 47-2204-2659
Dr Ingeborg S. Aaberge                                Fax: 47-2204-2301
National Institute of Public Health                   E-mail: ingeborg.aaberge@folkehelsa.no
P.O. Box 4404 Torshov
0403 Oslo, NORWAY

				
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