Next generation MAT vs. traditional pyrogen tests: faster, ethical, and more reliable
Dr. Nicole Rieth, Business Unit Manager ATMP & Biologics, Nicole.Rieth@bpt.eurofinseu.com; Dr. Frances Reichert, Technical Specialist Biologics, Frances.Reichert@bpt.eurofinseu.com; Eurofins BioPharma Product Testing Munich GmbH
Pyrogens – fever-inducing substances derived from bacteria, fungi, or viruses – pose serious health risks when present in injectable pharmaceuticals and are therefore a critical quality control measure to ensure patient safety. Traditionally, the Rabbit Pyrogen Test (RPT) has been the standard method for detecting pyrogens. However, RPT has raised ethical concerns due to animal use, while also suffering from low sensitivity and a lack of a quantitative measurement. In response to these limitations, the Monocyte Activation Test (MAT) was introduced as an in vitro alternative that mimics the human immune response. Recognised in the European Pharmacopoeia (Chapter 2.6.30) since 2010, MAT is set to fully replace RPT by July 1, 2025.
Eurofins BioPharma Product Testing Munich has evaluated various MAT kits, which assess the immune response using different human cells. While these MAT kits vary in their cell source and detection methods, the underlying principle remains the same: test samples are incubated with pyrogen-responsive cells, such as THP-1 macrophages or peripheral blood mononuclear cells (PBMCs), triggering the release of quantifiable cytokines like IL-6 or TNF-alpha. Eurofins BioPharma Product Testing Munich also had the opportunity to implement a Next Generation MAT kit ahead of its commercial launch. This advanced kit uses a reporter gene cell line, which provides results within a single working day – a significant improvement in efficiency, while maintaining comparable quality and sensitivity to existing MAT solutions.
The MAT offers numerous advantages over traditional methods, making it the superior choice for pharmaceutical safety testing:
- Semi-quantitative, sensitive, and reproducible results
- Detection of endotoxins (LPS) and non-endotoxin pyrogens (NEPs)
- Ethical, animal-free
- Accepted by regulatory bodies (FDA, EMA)
As the transition deadline approaches, pharmaceutical companies must adapt to this regulatory shift. Eurofins BioPharma Product Testing Munich is leading the way in providing state-of-the-art MAT solutions, supporting the industry’s move towards ethical and reliable pyrogen testing. For more information, visit: www.eurofins.de/media/uo3jjqge/monocyte-activation-test-mat.pdf