Monocyte Activation Test (MAT)
Pyrogen Testing Services
At CTL, we offer comprehensive Pyrogen Testing services, ensuring your parenteral pharmaceutical products and medical devices meet stringent safety standards. Pyrogens, substances that cause fever when introduced into the body, must be detected to ensure regulatory compliance.
Contact us today to discuss how our newly validated Pyrogen Testing service can help you meet global safety requirements.
Why Pyrogen Testing is Essential
The fever reaction results from monocyte activation caused by microbial contaminants. Traditional methods like the Rabbit Pyrogen Test (RPT) and the Limulus Amebocyte Lysate (LAL) test have limitations, particularly in detecting non-endotoxin pyrogens. This can leave manufacturers with incomplete safety assessments.
Our Monocyte Activation Test (MAT), in accordance with European Pharmacopoeia (Ph. Eur. 2.6.30, July 2016), offers a more comprehensive in vitro solution. MAT detects microbial contaminants by triggering interleukin-6 (IL-6) production in cryopreserved peripheral blood mononuclear cells (PBMC). When exposed to the test substance, microbial contaminants elicit IL-6 production, which is measured using an IL-6 ELISA in the culture supernatant.
MAT Testing – A Sensitive and Reliable Approach
MAT represents a highly sensitive bioassay, and its successful implementation requires:
- Fully functional monocytes as indicator cells.
- Optimized, pyrogen-free tissue culture conditions.
- Sensitive cytokine detection in the culture supernatant, primarily IL-6.
Regulatory Framework
The European Pharmacopoeia 8th Edition (Supplement 8.8) provides key updates:
- Monocyte Activation Test (MAT): Recommended as a replacement for the Rabbit Pyrogen Test (RPT) following product-specific validation.
- Bacterial Endotoxin Test (BET): Emphasizes comprehensive risk assessment, particularly for non-endotoxin pyrogens. MAT is a crucial part of this assessment.
CTL is the only company offering support for MAT implementation at your facility or testing services performed in our certified labs. Contact us to learn more and ensure your products meet the latest regulatory guidelines.
We ensure product-specific validation and interference matrices, thoroughly documenting the test procedure for regulatory compliance. Whether you require full testing services or setup guidance at your own facility, CTL is here to help.
