Application Note
Broad spectrum pyrogen detection according to pharmacopoeia
The Monocyte-Activation Test (MAT), which was introduced into the European Pharmacopoeia in 2010, detects pyrogens in pharmaceuticals. It covers a much broader range of pyrogens than the LAL Test, which traces only endotoxins. As an alternative to rabbit pyrogen testing (1) (2), the MAT allows better standardization and does not require animal consumption.
This paper shows the results of detection tests for a broad range of pyrogens using a commercially available MAT, Merck Millipore’s PyroDetect System. It explains the principle behind the MAT and illustrates how to perform a test in your lab.
References:
(1): EP 6.7 chapter 2.6.30
(2): FDA Guidance for Industry Pyrogen and Endotoxins Testing: Questions and Answers June 2012
