FDA Guidance Notes Monocyte Activation Test as a Suitable Replacement for the Rabbit Pyrogen Test
October 31, 2012 - Charles River is committed to expanding our portfolio with
in vitro alternatives to in vivo tests. In addition to the long-standing in vivo and
in vitro (e.g., LAL) tests for the detection of pyrogens and endotoxins, Charles River offers the Monocyte Activation Test (MAT). The MAT is used to detect or quantify substances that activate human monocytes or monocytic cells to release endogenous mediators.
In a recent guidance document, the FDA indicated that alternative tests such as the MAT may be substituted for the Rabbit Pyrogen Test as long as “equivalent Pyrogen detection” can be demonstrated (Guidance for Industry, Pyrogen and Endotoxins Testing: Questions and Answers, June 2012). The MAT is also considered “suitable, after a product-specific validation, as a replacement for the Rabbit Pyrogen Test” according to the European Pharmacopoeia Monograph 04/2010:20630.
The MAT works by predicting the human response to pyrogens on the basis of human fever, rather than animal models. The MAT offered by Charles River detects (by ELISA) the release of the important inflammatory mediator IL-1β from cryopreserved human blood.
Charles River offers clients the opportunity to work closely with our team of experienced staff to develop the MAT for testing their products. Our staff will work with clients to first determine the suitability of the MAT for testing their products; GMP product-specific validations may then be conducted on suitable products prior to its use in release testing.
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