Pyrogen detection is one of the mandatory release tests for sterile parenteral drugs testing in the course of pharmaceutical quality control. Test methods being used are the rabbit pyrogen test (RPT), the bacterial endotoxin test (or LAL test), and the monocyte activation test (MAT).
The Monocyte Activation Test’s human monocytic cells mimic the human reaction to pyrogens. The test is described in the European Pharmacopeia (chapter 2.6.30) and in other compendia, so in many countries there is no need to perform full method validation. The EP Commission recently decided to revise the parts of 59 Ph. Eur. that refer to the rabbit pyrogen test, putting the MAT on track as its replacement in the EU. The PyroMAT® system is currently the only cell-line based MAT kit on the market.
- Full-range detection of pyrogens (endotoxins and non-endotoxin pyrogens) in a single test
- Suitable for a wide range of pharmaceutical product types
- n vitro assay based on human cells: high transferability to humans, no harm to animals
- Compliant with EP and a replacement for the soon to be phased-out rabbit pyrogen test
- No need for cell culture equipment and skills, no handling of blood
Implementing the MAT regularly requires product-specific validation, and training is highly recommended. Among the services and trainings we offer are method development and validation services, feasibility studies, e-learning, training, consultancy, and software-based data analysis for routine testing, with a choice of face-to-face or remote services for many of the modules.