MAT is a non-animal alternative to the traditional rabbit pyrogen test and we are pleased to have introduced it as part of our commitment to the reduction, refinement, and replacement of animal testing.
The MAT was developed on the principle of the human immune system response: when challenged by the pyrogens entering the body or coming into contact with the blood stream, the host’s innate immune defence mechanisms cause the monocytes / macrophages to produce prostaglandins and pro-inflammatory cytokines such as interleukin-1 (IL-1), interleukin-6 (IL-6) and tumor necrosis factor-α (TNF- α).
The initiated pro-inflammatory signalling pathway can cause fever resulting in severe inflammation, organ-failure and even death. For the purpose of in vitro pyrogen detection, we verified a system which mimics this biological response by utilising cryo-preserved human monocytic cells as a source of monocytes and determining pyrogenicity of the tested sample by measuring the Interleukin-1β production in an immunological assay (ELISA). With this, we can detect both Gram-positive (non-endotoxin) and Gram-negative (endotoxin) contamination alongside other biological (virus, fungi) and non-biological pyrogens.
The MAT is an approved pharmacopoeial method; following the European Pharmacopoeia, any new product or device submitted for the MAT testing will be subjected to preparatory testing (product specific validation). As part of this, our experienced scientists will establish the suitability of the MAT method for each product, work on the development of an appropriate method and conduct a GMP product specific validation.
You may be interested to read our case study on the ‘Life Cycle of an Analytical Method – Monocyte Activation Test’.
If you are interested in the monocyte activation test at Wickham Micro, please complete our Contact Us and one of our experts will contact you back.