Immune cell line optimizes the detection of pyrogenic substances in medications and medical devices
Regulatory accepted CompanyMerck KGaA, Darmstadt, Germany
For safe and optimized detection of fever-causing substances in parenteral products, such as medications or medical devices, Merck offers the monocyte activation test (MAT) PyroMAT®. A human Mono-Mac-6 cell line is used to simulate the immune system. After thawing, the cryopreserved cells are immediately ready for use in the test and are characterized by their high sensitivity to pathogenic substances. The pyrogenicity of the test substance is determined by quantitative measurement of the inflammatory marker interleukin-6 (with the PyroDetect assay, the cytokine activation of interleukin-1β can also be assessed). By using the stable monocyte cell line, the test method overcomes the existing disadvantages of conventional methods. PyroMAT® enables the identification of endotoxin and non-endotoxin pyrogens, thereby closing an important detection gap in previous test methods. In addition, the assay is not limited to one type of substance and can therefore be used in different applications. So far it has been shown that the method has high sensitivity and is suitable for the reliable detection of a wide range of pyrogens in order to ensure the safety and quality of active ingredients and medical devices. The standardized test procedure has been proven to produce safe and easily reproducible results, and can thereby help to replace labor-intensive and imprecise safety testing methods.
Pyrogen testing
www.sigmaaldrich.com
Added on: 02-15-2024
[1] https://www.sigmaaldrich.com/DE/en/products/industrial-microbiology/pyrogen-testing
