Suitability Of The Mono-Mac-6 Cell Line For The Detection Of Endotoxins And Non-Endotoxin Pyrogens

Pyrogen detection is one of the mandatory release tests for sterile parenteral drugs. Today, the two main test methods in use are the bacterial endotoxin test (or LAL test) and the rabbit pyrogen test (RPT).

Another pyrogen test, the monocyte activation test (MAT) uses human monocytic cells to mimic the human reaction to pyrogens in vitro. The MAT can use cryopreserved whole blood, peripheral blood mononuclear cells (PBMC), or monocytes from the Mono-Mac-6 cell line (MM6).

The MM6 cell line, which has been validated for use in the MAT and is listed amongst the valid sources of monocytes for the MAT in the European Pharmacopeia, has sometimes been questioned over its ability to detect non-endotoxin pyrogens (NEPs). To demonstrate its performance, tests have been performed using a wide panel of monocytic toll-like receptors (TLRs) ligands.