Stefanie Schindler

Evidence for the detection of non-endotoxin pyrogens by the whole blood monocyte activation test.

Threats of pyrogenicity were discovered more than a century ago. Measures to determine the safety of parenterals and, more recently, medical devices and cell therapies for human use have been in place for 70 years. Currently, there are three testing possibilities available: the Rabbit Pyrogen Test, the Limulus Amebocyte Lysate test (Bacterial Endotoxin Test), and test systems using human whole blood or human monocytes, called Monocyte Activation Test (MAT). The MAT is based on the human fever reaction and thus most closely reflects the human situation. Unfortunately, regulations and testing guidelines are not fully harmonized, despite formal international validation. Furthermore, data showing that the MAT is capable of covering the totality of possible pyrogens relevant to humans were not included in the MAT validations of the last decade. For this review we collate evidence from published literature, unpublished data of our own, and results from the international validation study to show that there is overwhelming scientific evidence to conclude that the whole blood MAT reliably detects non-endotoxin pyrogens. Therefore, further validation exercises do not seem warranted.

The 9th World Congress on Alternatives and Animal Use in the Life Sciences

The 5 World Congress is staged in Berlin from 21-25 August 2005. ZEBET (Centre for Documentation and Evaluation of Alternatives to Animal Experiments) within the Federal Institute for Risk Assessment (BfR) is the co-organiser of the Congress. The 5 World Congress is organised by the American foundation ACT (Alternatives Congress Trust). The Foundation administers the funds donated by animal welfare organisations, industry and state institutions for the purposes of increasing the use of alternatives to animal experiments.