A new test for the detection of pyrogens in pharmaceutical products. Examinations for the validation of the human whole blood assay.

The human whole blood assay utilises the natural fever response to detect pyrogens by determination of the release of IL-1beta. In order to replace the official method, the rabbit pyrogen test, a validation of the whole blood assay is necessary. A comparison of the results obtained from many blood samples has revealed the following: 1) Blood not stimulated by LPS does not produce IL-1beta.

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

When cells of the immune system, i.e. primarily blood monocytes and macrophages, come into contact with pyrogens (fever inducing contaminations) they release mediators transmitting the fever reaction within the organism.