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Revolutionize Pyrogen Testing with CellMade MAT Testing Services

Revolutionize Pyrogen Testing with CellMade MAT Testing Services

  12 07 2023

Testing for pyrogenic contamination in sterile parenteral drugs and medical devices is a crucial quality control measure mandated by international regulatory bodies. The European Pharmacopeia (EP), European GMP – Annex 1, USP 151, and FDA Guidance all stress the importance of rigorous pyrogen testing. If you're in search of a groundbreaking solution that surpasses traditional methods, your answer lies with CellMade MAT Testing Services. We harness the power of Monocyte Activation Test (MAT) to provide unparalleled efficiency and precision for your pyrogen testing needs.

So, what exactly is MAT Testing? By utilizing human blood to simulate the early stages of the human immune system, MAT Testing is an in vitro assay designed to evaluate parenteral drugs, biologics, and medical devices for all types of pyrogens. While the Rabbit Pyrogen Test has been the gold standard for a century, regulatory bodies such as the European Pharmacopeia (Ph. Eur.) are now urging the adoption of in vitro alternatives. Specifically, the Monocyte Activation Test is recommended whenever feasible and after product-specific validation (2.6.8).

Why is it important to focus on non-endotoxin pyrogens (NEP) in addition to common endotoxins? Recent research highlights NEPs as potential causes of adverse reactions, including pain, redness, shivering, and fever. The Ph. Eur. mandates a non-endotoxin pyrogen "risk assessment" when utilizing the Bacterial Endotoxin Test (BET) as a release assay. To ensure comprehensive pyrogen testing, this assessment must be conducted using the Monocyte Activation Test.

Vaccines, which previously relied on the Rabbit Pyrogen Test, have been among the early adopters of the Monocyte Activation Test (MAT). Unlike MAT, Bacterial Endotoxin Tests are often unsuitable for inherently pyrogenic products or those containing additives like aluminium hydroxide, which can interfere with the assay (Hartung, 2021).

Revolutionize Pyrogen Testing with CellMade MAT Testing Services. Unparalleled precision, efficiency, and reliability. Say goodbye to traditional methods. Streamlined sample submission. Superior sensitivity and specificity. Automated system for consistent results. Versatile to meet diverse needs. Fast turnaround time. Gain a competitive edge. Contact us today and shape the future of pyrogen testing!