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.
NMI TT offers the 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).
Our LAL assay uses the reaction of blood cells from Limulus polyphemus to coagulate in contact to endotoxins. Our MAT assay is based on cytokine release of activated human monocytes after contact to pyrogens.
Both methods can be performed according to GMP.