1/2 March 2023
In recent years, the field of endotoxin and pyrogen testing has undergone many changes - starting with the search for recombinant alternatives to LAL, the development of MAT as a replacement for the classical rabbit test, and the findings on masking effects in the testing of biological drugs and active substances. Many of these developments have been controversial, especially the effect of masking/low endotoxin recovery and currently the question of the comparability of the test of recombinant test systems with LAL test systems. The continued use of the rabbit test has also led to discussions as long as there are countries that require it for drug approval.
The replacement of the rabbit test in particular was driven by the "3R strategy" (Replace, Reduce and Refine) of the EU member states. The inclusion of the Monocyte Activation Test (MAT) in the European Pharmacopoeia was also an important step. On June 28, the EDQM/Council of Europe issued the press release "European Pharmacopoeia to put an end to the rabbit pyrogen test" announcing the end of the rabbit test.