Manufacturers must now use in vitro methods for pyrogen testing of parenteral drugs, biologics, and medical devices.
Recommended by the EP, the Monocyte Activation Test (MAT) mimics human immune response, and detects both endotoxin and non-endotoxin pyrogens from bacteria, fungi, viruses, and other particles.
PyroMAT® system uses cryo-preserved MM6 human monocytic cells, offering superior sensitivity, reproducibility, and broader compatibility than RPT/BET methods.
Commercialized since 2018, it’s fully validated according to EP 2.6.30 07/2024 including the USP <1225> analytical characteristics.
