Advances in the application of monocyte activation test assay in the detection of pyrogens
LIU Si-hua
FANG Yu
HONG Qi-hao
YAN Wen-hui
SU Gui-min
DU Lin
Abstract：Pyrogen detection is an important part of quality control during the development and manufacture of biological products.The monocyte activation test(MAT)is a novel pyrogen detection method designed based on the mechanism of human febrile response.Compared with the traditional rabbit pyrogen test(RPT)and bacterial endotoxins test(BET),MAT has the advantages of in vitro detection,high sensitivity,compliance with the"3R"principles,and capability of recognizing various pyrogens.It has been included in the European Pharmacopoeia since 2010.At present,the Chinese Pharmacopoeia(Vol Ⅳ,2020 edition)has included it as a supplementary method for pyrogen detection.In order to promote the application of MAT in domestic pharmaceutical quality control,this paper mainly analyzed the differences in sensitivity and variability between MAT and traditional pyrogen detection methods based on the principle,detection materials,and methods of MAT.The present state of MAT application in biopharmaceuticals was summarized,focusing on analyzing the features of the approach,the obstacles it encounters,and the direction of its future progress from a scientific perspective,in order to provide theoretical reference for the promotion and application of MAT.
Keywords：pyrogen detectionmonocyte activation testrabbit pyrogen testbacterial endotoxins testvaccine
Publication Date：2025-09-30
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：8( 1944-1951 )