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More Sensitive Non-Endotoxin Pyrogen Detection Now Possible

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Lonza has launched the PyroCell® Monocyte Activation Test - Human Serum System (PyroCell® MAT HS System), which uses human serum instead of fetal bovine serum. This new in vitro pyrogen testing system exhibits enhanced sensitivity for detection of non-endotoxin pyrogens as well as reduced interferences from complex drug products such as biologics-based pharmaceuticals.

By replacing fetal bovine serum, the new PyroCell® MAT HS System increases sustainability by reducing the need for experimental animals and animal-derived components in pyrogen testing. Pharmaceutical manufacturers globally can now rely on Lonza for a range of high-quality, sensitive and sustainable in vitro pyrogen tests.

Janet Yancey-Wrona, Head of Marketing for Testing, Lonza BioScience, commented: “The pharmaceutical industry is looking to future-proof its quality control testing programs by reducing the use of experimental animals while employing robust tests suitable for use with the diversity of emerging biologics products. To support the unique needs of these new modalities and facilitate this shift, we are leveraging our collaboration with Sanquin Reagents to add the PyroCell® MAT HS System to our testing portfolio. With our expanded offering of sustainable tests, customers can select the best in vitro pyrogen and endotoxin tests for their specific needs.”

The Monocyte Activation Test (MAT) is an in vitro pyrogenicity test that mimics the human immune response to both bacterial endotoxin and non-endotoxin pyrogens (NEPs). As such, the MAT offers an ideal solution to replace the rabbit pyrogen test, thereby reducing reliance on experimental animals.

Conducting the MAT involves a cell culture step that requires a serum source, and different serum sources provide different reactivity profiles. Using human serum in place of fetal bovine serum improves the sustainability of pyrogen testing by reducing the use of animal-derived components. Furthermore, the use of human serum in the PyroCell® MAT HS System may exhibit decreased interferences from complex product matrices and increased sensitivity to NEPs, improving the reliability of in vitro pyrogen testing.

The new PyroCell® MAT HS System adds a second pyrogen test to Lonza’s pyrogen testing portfolio, providing robust and reliable pyrogen testing to customers throughout Lonza’s global network. Customers can now choose the best pyrogen test system for their specific needs and take advantage of Lonza’s expert technical service to support implementation and optimize testing processes.