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Comparison and validation of novel pyrogen tests based on the human fever reaction

Objective

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.

Funding Scheme

CSC - Cost-sharing contracts

Coordinator

STEINBEIS TECHNOLOGY TRANSFER CENTER FOR IN-VITRO PHARMACOLOGY AND TOXICOLOGY
Address
Universitaetsstr. 10
78457 Konstanz
Germany

Participants (10)

COMMISSION OF THE EUROPEAN COMMUNITIES
Italy
Address
Via Enrico Fermi 1
21020 Ispra
DPC BIERMANN GMBH
Germany
Address
Hohe Strasse 4-8
61231 Bad Nauheim
INSTITUT FUER MEDIZINISCHE CHEMIE UND BIOCHEMIE AN DER UNIVERSITAET INNSBRUCK
Austria
Address
Fritz-pregl-strasse 3
6020 Innsbruck
MILENIA BIOTEC GMBH
Germany
Address
Hohe Strasse 4-8
61231 Bad Nauheim
NATIONAL BIOLOGICAL STANDARDS BOARD
United Kingdom
Address
Blanche Lane, South Mimms
Potters Bar
NATIONAL INSTITUTE OF PUBLIC HEALTH AND ENVIRONMENT
Netherlands
Address
Antonie Van Leeuwenhoeklaan 9
3720 BA Bilthoven
NORWEGIAN INSTITUTE OF PUBLIC HEALTH
Norway
Address
75,Geitmyrsveien 75 Torshov
0403 Oslo
NOVARTIS PHARMA AG
Switzerland
Address
Lichtstrasse 35
Basel
PAUL-EHRLICH-INSTITUT, FEDERAL AGENCY FOR SERA AND VACCINES
Germany
Address
Paul-ehrlich-strasse 51-59
63225 Langen
UNIVERSITY OF BERNE
Switzerland
Address
5,Hochschulstrasse 4
3012 Bern