Pyrogens – fever-inducing substances originating from bacteria, fungi, or viruses – pose significant health risks when present in injectable pharmaceuticals. As a critical quality control measure, pyrogen detection ensures patient safety. Historically, the Rabbit Pyrogen Test (RPT) has been the standard method for pyrogen detection. However, RPT presents ethical and sustainability concerns, alongside limitations in sensitivity and the lack of quantitative measurement. To address these issues, the Monocyte Activation Test (MAT) was introduced as an in vitro alternative, replicating the human immune response. Recognised in the European Pharmacopoeia (Chapter 2.6.30) since 2010, MAT is set to completely replace RPT by July 1, 2025.
Eurofins BioPharma Product Testing Europe has conducted extensive evaluations of various MAT kits, each utilising different human cell sources for immune response assessment. While these kits differ in their detection methods, the fundamental approach remains consistent: test samples are incubated with pyrogen-sensitive cells, such as THP-1 macrophages or peripheral blood mononuclear cells (PBMCs), leading to the release of measurable cytokines like IL-6 or TNF-alpha. Additionally, our teams had the opportunity to implement a next-generation MAT kit prior to its commercial launch. This advanced system incorporates a reporter gene cell line, enabling results within a single working day – a significant enhancement in efficiency while maintaining the high sensitivity and reliability of existing MAT technologies.
As the regulatory transition deadline is approaching fast, pharmaceutical companies must adapt to this shift. Eurofins BioPharma Product Testing Europe, with its international team of experts, is at the forefront of this transformation, offering cutting-edge MAT solutions to support the industry’s transition to more ethical and reliable pyrogen testing.
Making the Transition?
Contact us or visit our In vitro pyrogen testing with MAT webpage for more information.
Request access to our on-demand webinar: Next-Generation MAT vs. Traditional Pyrogen Tests: Faster, Ethical, and More Reliable