Pyrogenicity

Pyrogens are fever causing agents like components of microorganisms (e. g. Endotoxins) and material surfaces. In parenterally applied drugs and medical devices in contact with the human body they can be a major health hazard. Therefore regulatory requirements demand for testing their potential pyrogenicity.

The NMI TT offers Monocyte Activation Test (MAT) which is able to detect pyrogenic compounds or material surfaces in vitro and endotoxin testing by Limulus Amoebocyte Lysate assay (LAL).

The LAL uses the reaction of blood cells from Limulus polyphemus to coagulate in contact to endotoxins. The MAT bases of cytokine release of activated human monocytes after contact to pyrogens. Both methods can be performed according GMP.