Monday, 22 August 2016

Revised monocyte activation test chapter



During its 155th Session, held in Strasbourg on 21-22 June 2016, the European Pharmacopoeia Commission adopted a revision of the general chapter Monocyte-activation test (2.6.30) in order to make it more widely useable by stakeholders and thus facilitate a reduction in testing on live animals.

The MAT is suitable, after product-specific validation, as a replacement for the rabbit pyrogen test (RPT). The MAT offers significant advantages over animal testing: based on the human fever response, it provides a more relevant prediction of pyrogenic activity than the RPT, it can detect endotoxin and non-endotoxin pyrogens and is applicable to a greater variety of products than the RPT; moreover, it is more accurate as well as more cost- and time effective than the RPT.

For further details see: EDQM

Posted by Dr. Tim Sandle