Wickham Laboratories is pleased to announce the introduction of a new in vitro test method, the Monocyte Activation Test, 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.
We have successfully verified the Merck PyroDetect System for the purpose of the pyrogenicity assessment via MAT according to European Pharmacopoeia 2.6.30. The MAT can detect pyrogenic contamination such as:
- Gram-positive (non-endotoxin)
- Gram-negative (endotoxin)
- Other biological (virus, fungi)
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.
As a GMP/GLP compliant laboratory with over 50 years of experience, Wickham Laboratories Ltd is an established name in the fields of pharmaceutical and medical device contract testing, research and consultancy. We conduct business with clients worldwide and the combined expertise of our laboratory technicians and managers enables us to be fully conversant with global regulatory expectations.
We are committed to providing a quality testing service, combining high levels of client satisfaction together with the maintenance of appropriate accreditation. This and the continual pursuit of delivering excellence remain central to our business.
Please get in touch today at +44 (0)1329 226600 or firstname.lastname@example.org to discuss product specific validation for your pyrogen testing requirements.