Pyrogens are fever-inducing substances from bacteria, fungi, viruses or environmental particles that pose a serious risk to patient health when present in injectable products. Detecting them is a critical quality control measure to ensure product quality and therefore patient safety. For testing according to the European Pharmacopeia (11th edition), manufacturers must replace the Rabbit Pyrogen Test (RPT) with the Monocyte Activation Test (MAT) by July 1, 2025, as mandated by the European Directorate for the Quality of Medicines & HealthCare (EDQM). With the regulatory sunset of the Rabbit Pyrogen Test (RPT) fast approaching, and growing pressure to adopt in-vitro, ethically sound, and more accurate alternatives, manufacturers are in urgent need of a partner they can trust.

Eurofins BioPharma Product Testing network of laboratories delivers an advanced, reliable solution with the MAT. This in vitro assay offers a highly sensitive and accurate method for detecting the pyrogens in injectable pharmaceuticals. Our labs are equipped with cutting-edge technology, and expert scientists with decades of collective experience. The MAT is carried out under GMP-compliant conditions and meets all current regulatory expectations, supporting manufacturers as they transition from RPT to MAT before the July 2025 deadline. Our testing methods not only comply with ethical standards and public expectations, they also provide quantitative data to better analyse and ensure the safety of your products.