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

The absence of pyrogens (fever-inducing contamination) in injectable drugs is a crucial safety control because pyrogens can pose a life-threatening risk to the patient. The field of applications for pyrogen-testing is expanding and becoming more diverse due to innovative high-tech products such as medical devices, cellular therapies and species-specific agents (e.g. recombinant proteins). The overall aim of the consortium is to develop, evaluate and validate a method based on the human fever reaction to replace the rabbit pyrogen test and the Limulus assay. The network brings together the six most prominent test systems developed recently in Europe for trans-national comparison and subsequent validation of the most promising models. This pre-competitive development will initiate further applications and exploitations for new fields of pyrogen testing such as cellular therapies, medical devices and pyrogen pollution control in the work place. A method for introduction into the European Pharmacopoeia will be developed as a replacement for the rabbit pyrogen test for end-product control.