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Content archived on 2024-06-17

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.

Call for proposal

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Coordinator

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

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Total cost
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Participants (10)