Regulations are now evolving to support in vitro methods.
Now is the time, to stop animals-based
tests for Pyrogen Detection
In June 2021, the European Pharmacopoeia (Ph. Eur.) Commission made the decision to engage on a path that should ultimately lead to the complete replacement of the rabbit pyrogen test (RPT) in the Ph. Eur., within approximately 5 years. In the meantime, users are actively encouraged to seek alternatives to chapter 2.6.8, the best option being the Monocyte Activation Test (MAT).
Used to detect a broad range of pyrogens in parenteral products such as pharmaceuticals, biopharmaceuticals or medical devices, the MAT gives an in vitro alternative to conventional animal testing in accordance with regulatory guidelines.
With our Mono-Mac-6 cell-line based MAT, we provide a robust, reliable and standardized method for pyrogen detection.
For our PyroMAT® system, we have a broad offer of Services and Trainings to support the implementation of the monocyte activation test (MAT) in your lab: