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.
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.
To overcome these limitations, the Monocyte-Activation Test (MAT) was introduced in the European Pharmacopoeia in 2010 as a compendial method to replace the Rabbit Pyrogen Test (EP Chapter 2.6.30) and mentioned in FDA guidance for industry.
Please Note: The European Pharmacopoeia Commission took the decision to put an end to the rabbit pyrogen test in accordance with the 3Rs principle considering that the MAT is the best alternative option.
Read the article and discuss further with our Experts to start the move.
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.
Read more about Non-endotoxin Pyrogen Positive Controls.
The European Pharmacopeia Chapter 2.6.30 (Monocyte Activation Test) requires that the preparatory testing includes "at least 2 non-endotoxin ligands for toll-like receptors […]. The choice of non-endotoxin pyrogens used should reflect the most likely contaminants(s) of the preparation being examined."
To respond to this requirement, we are providing an extended range of positive controls:
The PyroDetect system is based on cryopreserved human whole blood and IL1β read-out.
Optimize or simplify your pyrogen testing method for an easy validation and cost-effective testing with our service offerings:
Comparison of rabbit, LAL and MAT pyrogen tests
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Feasibility study, method development, validation & training services to support your pyrogen testing implementation, discuss with our Pyrogen Testing Experts.