BioTech/Drugs - Shaker Heights, OH, US
Our mission is to enable reliable and ethical drug releases thus reducing unnecessary animal-based testing. The Monocyte Activation Test (MAT) is an in-vitro bioassay that detects cytokine release by monocytes contained in human Peripheral Blood Mononuclear Cells (PBMC) when these are exposed to microbial products. As opposed to the Limulus Amebocyte Lysate Test (LAL) that detects lipopolysaccharides (LPS) of Gram-negative bacteria only, MAT also detects constituents of Gram-positive bacteria, fungi and viruses. MAT is equally suited for the detection of microbial contaminants as the traditional Rabbit Pyrogen Test (RPT), but avoids the unnecessary reliance on animal testing. Therefore, MAT has evolved as the leading in-vitro alternative to RPT for the mandatory batch release testing of parenteral drugs and medical devices, verifying that they have not been contaminated with microbial products and are safe to administer. The MAT is recommended by the European Pharmacopeia for batch release testing of drugs and medical devices.Representing a sensitive in-vitro bioassay, successful implementation of MAT critically depends on the availability of fully functional monocytes as indicator cells, optimized and pyrogen-free tissue culture conditions, and a sensitive cytokine detection in the culture supernatant. Our experts are available to perform and interpret test results, including product-specific validation and interference matrices, all while documenting and reporting the test procedure to meet regulatory compliances. CTL-MAT is the only company that can help you with any and all these requirements for performing the MAT at your facility – or we can perform the test for you in our own certified laboratories.
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