Evaluation and further development of a pyrogenicity assay based on human whole blood

Evaluation and further development of a pyrogenicity assay based on human w hole blood When cells of the immune system i.e. primarily blood monocytes and macropha ges, come into contact with pyrogens (fever inducing contaminations) they r elease mediators transmitting the fever reaction within the organism. A new pyrogen test exploits this reaction for the detection of pyrogens: human w hole blood taken from healthy volunteers is incubated in the presence of th e test sample. In case of pyrogen contamination, the formation of interleuk in-1 is induced, which is determined by ELISA. According to the various pharmacopoeia, the rabbit pyrogen test determines the fever reaction following injection of a test sample. In comparison, the new whole blood assay is more sensitive, less expensive and determines the reaction of the targeted species, in contrast to the well established in v itro alternative, i.e. the limulus amebocyte lysate assay (LAL), the blood assay is riot restricted to endotoxins of Gram-negative bacteria and is not to the same Extent disturbed by endotoxin-binding blood proteins. Here, interim results of the ongoing optimisation and prevalidation are dem onstrated. Preliminary data of the evaluation for biological and pharmaceut ical drugs are presented.