Monocyte Activation Test (MAT)
At ImmunoSpot, we provide comprehensive Pyrogen Testing Solutions to ensure your parenteral pharmaceutical products and medical devices comply with the highest safety standards. Detecting pyrogens—substances that induce fever—is critical for regulatory compliance and patient safety.
Contact us today to learn how our newly validated Pyrogen Testing Solutions can help you meet international safety regulations.
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MAT Test Kit
Why Pyrogen Testing Matters
Fever reactions stem from monocyte activation triggered by microbial contaminants. Traditional tests like the Rabbit Pyrogen Test (RPT) and the Limulus Amebocyte Lysate (LAL) test have their limitations, especially in detecting non-endotoxin pyrogens, often leading to incomplete safety evaluations.
Our Monocyte Activation Test (MAT)—aligned with European Pharmacopoeia (Ph. Eur. 2.6.30, July 2016)—offers a comprehensive in vitro alternative. MAT detects microbial contaminants by stimulating interleukin-6 (IL-6) production in cryopreserved peripheral blood mononuclear cells (PBMC). When the test substance contains contaminants, it triggers IL-6 release, which is quantified by IL-6 ELISA in the culture supernatant.
MAT Testing — A Reliable, Sensitive Approach
MAT is a highly sensitive bioassay that demands:
Fully functional monocytes as indicator cells
Optimized, pyrogen-free culture conditions
Sensitive cytokine detection, primarily IL-6, in the culture supernatant
Regulatory Framework
The European Pharmacopoeia 8th Edition (Supplement 8.8) highlights:
MAT is recommended as a validated replacement for the Rabbit Pyrogen Test (RPT) following product-specific validation.
Bacterial Endotoxin Test (BET) stresses the importance of thorough risk assessments for non-endotoxin pyrogens, making MAT a key component.
