PyroCell MAT HS System "Monocyte Activation Test" Lonza
A new in vitro pyrogen test method, MAT (Monocyte Activation Test), as a substitute for the rabbit pyrogen test.
The Monocyte Activation Test (MAT) is an in vitro test based on the detection of inflammatory cytokines released from human blood monocytes in response to stimulation by pyrogens (fever-inducing substances). MAT can detect endotoxins as well as non-endotoxin pyrogens (NEPs) in raw materials, intermediates, manufacturing samples, and manufactured products within the biopharmaceutical or medical device industry. The measurement method involves first exposing the test substance to PyroCellRpMAT cells and incubating them at 37°C for 18 to 24 hours. Subsequently, IL-6 secreted into the culture supernatant is detected using an anti-IL-6 ELISA method to create a standard curve. The IL-6 present in the test sample is quantified based on the absorbance detected by the anti-IL-6 ELISA, calculating the pyrogenic activity (EU/mL). This kit complies with the regulatory requirements outlined in the European Pharmacopoeia (Chapter 2.6.30) and targets IL-6, which has been clinically confirmed to correlate with pyrogens among inflammatory cytokines. By detecting the molecular weight of IL-6 in cell culture supernatants using the ELISA method, it is possible to quantitatively analyze the pyrogenic activity expressed as endotoxin units (EU/mL).
- Company：ロンザ
- Price：Other
