PyroCell Monocyte Activation Test (MAT) Kit qualified for the monocyte activation test including 3 vials pooled PBMC (pMAT cells, 4 donors) as well as 3 vials of Cell Culture Medium Supplement for 3 x 96-well ELISA plates.
The Monocyte Activation Test (MAT) is an in vitro assay for pyrogen testing in the biopharmaceutical or medical device industry. The MAT test principle is based on the detection of inflammatory cytokines released by human monocytes in response to exogenous endotoxins (LPS) and non-endotoxin pyrogens (NEP).
The PyroCell MAT Kit contains a human peripheral blood mononuclear cell preparation pooled from 4 healthy donors (pMAT cells), and has been specifically qualified for endotoxins and pyrogen testing with the MAT. Thereby, donor selection, cell preparation and quality testing strictly follow the requirement of the European Pharmacopeia. The optimized MAT Cell Culture Medium Supplement component of the PyroCell MAT Kit has been formulated with special attention to a low endotoxin content in order to ensure error-free cell stimulation conditions. The PyroCell MAT Kit is optimized for use with the PeliKine Compact human IL-6 ELISA Kit and Tool Set. All components together represent the PyroCell MAT Assay System, IL-6 supporting the complete testing of 3x 3 product samples according to the compendial requirements of the European Pharmacopeia. The historical LOD of the PyroCell MAT assay system, IL-6 is ≤ 0.02 EU/ml.
The MAT assay is performed in two steps: during an overnight cell culture step, a monocytic cell preparation, e.g. peripheral blood mononuclear cells (PBMC) is stimulated for release of inflammatory cytokines with a product preparation that may contain a pyrogenic contaminant. On the next day, the cell culture supernatant is analyzed for the presence of released cytokines using an ELISA assay. The color reaction is measured in an absorbance reader, e.g. the ELx808 Reader, at a wavelength of 450 nm and a reference wavelength of 540-590 nm. The pyrogenic content of the sample is then analyzed against the reference standard endotoxin (RSE) and is expressed in Endotoxin Equivalent Units (EEU/mL).
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