Tentamus Pharma & Med Deutschland GmbH presents its test platform for the detection of pyrogens based on the monocyte activation test

Pyrogenic substances are one of the most dangerous impurities in all parenteral drugs and medical devices. The rabbit pyrogen test (RPT) has long been the gold standard for the detection of pyrogenic activity. Due to its ethical questionability, an in vitro test system has long been sought as a replacement for the RPT, which follows the rules of the 3R principle (reduction, substitution and refinement) for the reduction of animal studies.

The European Pharmacopoeia has now introduced a groundbreaking innovation in the field of pyrogen testing with the abolition of the traditional rabbit pyrogen test (RPT). This decision sets new ethical standards and promotes the development of innovative in-vitro alternatives such as the monocyte activation test (MAT). In this context, Tentamus Pharma & Med Deutschland GmbH (TPMD) is proud to present its own validated platform for testing pyrogens based on the monocyte activation test according to the requirements of Ph. Eur chapter 2.6.30. The MAT represents a new important building block in the biological safety concept of the TPMD site in Karlsruhe. TPMD is one of the few laboratories able to offer MAT accredited for the safety testing of medical devices and GMP-certified for the evaluation of medicinal products.