Monocyte Activation Test
Wickham Laboratories is pleased to announce the introduction of a new in vitro test method, the Monocyte Activation Test (MAT), for the assessment of pyrogenicity of pharmaceutical products and medical devices. The 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 the Merck PyroDetect System which mimics this biological response by utilising cryo-preserved human whole blood as a source of monocytes and determining pyrogenicity of the tested sample by measuring the Interleukin-1β production in an immunological assay (ELISA). PyroDetect System 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; we have successfully verified the Merck PyroDetect kit as a suitable system for the performance of the Monocyte Activation Test. Following the European Pharmacopoeia, any new product or device submitted for the MAT testing will be subjected to preparatory testing (product specific validation) – 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 recently produced case study ‘Life Cycle of an Analytical Method – Monoctye Activation Test’ written by one of our technical experts.
If you are interested in the monocyte activation test or pyrogen testing at Wickham Laboratories, please complete our contact form below and one of our experts will contact you back.