Description
Product Overview 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). Since its first adoption into the European Pharmacopeia in 2010 (Ph. Eur. chapter 2.6.30) the MAT assay is recognized as a compendial method for pyrogen testing in a number of world regions including Europe. Here, the MAT is recommended as a replacement test for the Rabbit Pyrogen Test (RPT) (1). The MAT is further compliant to the global framework of the 3Rs principle (replacement, refinement, reduction of experimental animal tests).(2) 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 Human IL-6 ELISA Rapid 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). The following reagents, accessories and instruments are used to support the PyroCell® MAT Assay System: Step 1: Monocyte Activation Product Catalog # Iscove's Modified Dulbecco's Medium (IMDM) with L-Glutamine and HEPES 12-722F USP Reference Standard Endotoxin E700 LAL Reagent Water W50-100 Pyrogen-free Dilution Tubes N207 Reagent Reservoirs 00190035 LAL Reagent Grade TM Multi-well Plates 25-340 Endotoxin-free accessories, i.e. sample container, pipette tips, serological pipettes See Catalog Step 2: IL-6 ELISA Assay Product Catalog # PeliKine Human IL-6 ELISA Rapid Kit 00296406 Endotoxin-free accessories, i.e. sample container, pipette tips, serological pipettes See Catalog (1) European Pharmacopeia (2) Global framework 3R Request More Info
Benefits Sustainable pyrogen test system avoiding the use of experimental animals Compliant with regulatory requirements, detects the full range of pyrogens Qualified cells ensure reliable assay performance and reproducible results Optimized assay components ensure high sensitivity and minimize qualification work Fully compatible to Lonza hardware Applications Pyrogen testing of raw materials, pharmaceutlical preparations, medical devices In-Process testing for pyrogens to support development of new production processes Ideal for biological products and production processes for example, proteins, antibodies, lipid pharmaceuticals, and vaccines
Storage and Content 3 vials pMAT cells (4 donors) shipped on dry ice. Immediately store at ≤ -80°C 3 vials Cell Culture Medium Supplement. Immediately store at ≤ -80°
