Rabbits, rejoice: The end is nigh!
Specifically, the end for the Rabbit Pyrogen Test (RPT). First introduced to regulatory documents in the 1940s, it has been the official test to detect pyrogen contaminations in pharmaceuticals for decades. However, science marches on, and other tests have become available. The first was the Bacterial Endotoxins Test, which since has risen to be the “go-to” test in most cases. It’s not always applicable, though, as it only detects endotoxins and not all pyrogens. Therefore, a major step was the invention of the Monocytes Activation Test (MAT) in the 1990s, which is a direct replacement for the RPT.
Nowadays, animal testing is being increasingly frowned upon. European authorities have been critical about the continued use of RPT for years, especially as an alternative in-vitro-test exists and is recognized as a compendial assay as per the European Pharmacopoeia (Ph. Eur., Chapter 2.6.30. Monocyte-Activation Test, since 2009).
On 28 June 2021, the Ph. Eur. issued a press release announcing that they are finally putting a stop to the RPT. Within the next five years, so the approximated timeline, references to pyrogen testing with RPT in monographs will be replaced “with a suitable in-vitro alternative, ultimately leading to the complete elimination of the RPT”. The aim is to push companies to adopt the MAT instead.
With this, the Ph. Eur. actively supports yet again efforts towards the goal of “3R” – i.e. to replace, reduce, or refine use of animal for testing everywhere.
Written by Saskia
Scientific Support Specialist, Lonza Pharma-Bioscience Solutions at Lonza
