Testing for pyrogens is a critical step in ensuring parenteral pharmaceutical product and medical device safety. It is part of the mandatory release tests to avoid life-threatening fever reactions induced by pyrogenic substances. The monocyte activation test (MAT) can detect both endotoxin and non-endotoxin pyrogens in one in vitro test.

MONOCYTE ACTIVATION TEST (MAT)
Used to detect both endotoxins and non-endotoxin pyrogens in parenteral products, such as pharmaceuticals and medical devices, the MAT gives an in vitro alternative to conventional animal testing in accordance with regulatory guidelines.

The Rabbit Pyrogen Test and the Limulus Amebocyte Lysate (LAL) test are broadly used for pyrogen detection. Both methods use animals and show some limitations. The rabbit pyrogen test shows a lack of robustness as an animal reaction can differ greatly from a human reaction. In the LAL test, only endotoxins are detected causing a safety risk by ignoring non-endotoxin pyrogens that could be present in the tested sample.

PyroMAT® IN VITRO TEST TO DETECT ENDOTOXIN AND NON-ENDOTOXIN PYROGENS
The PyroMAT® system is based on the Mono-Mac-6 cell line and IL-6 read-out. It offers all the advantages of the monocyte activation test combined with the benefits of using a cell line.

• Detection of a broad range of pyrogens: patient safety is ensured if the full range of pyrogens are tested. Like the rabbit pyrogen test (RPT), MAT is effective for both endotoxin and non-endotoxin pyrogen detection.
• Extension of the range of products that can be tested: the most frequently applied methods, RPT, Bacterial Endotoxin Test (BET) or LAL, are limited in the product types they are able to test. The MAT offers more flexibility regarding its applications.
• In vitro assay that mimics the human immune reaction: for a robust predictive model that reduces animal consumption.