Pyrogens, alternative methods: monocyte activation test

Despite several techniques can be used to detect pyrogens and endotoxins, the historical in-vivo method, the Rabbit Pyrogen Test (RPT) and the in-vitro Limulus Amebocyte test (LAL) also known as Bacterial Endotoxins Test (BET) are still the most commonly used methods.

This has slowly started to change after the Monocyte Activation Test (MAT) was developed and recognised as an alternative method to RPT and included into Ph. Eur. as compendial method in 2010 and USP as an alternative method in 2012.

Furthermore, MAT is mentioned as a pyrogen test in guidelines for pyrogen detection in medical devices, namely ISO/TR 21582:2021 – Pyrogenicity “Principle and method for pyrogen testing of medical devices”.

Even though lack of harmonisation between Pharmacopoeias is one of the main hurdles, the recent European Pharmacopoeia Commission pyrogenicity strategy has traced the path that will lead to the complete removal of the RPT from Eur. Ph. by July 2026 and the publication of a specific pyrogenicity general chapter.

This webinar aims to give an insight about the technical aspects of MAT and its regulatory framework, discussing current challenges such as material mediated pyrogenicity.