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).
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Product Composition ■ pMAT Cells 288 tests (3 vials) - Store at -80°C or below ■ Human Serum Supplement 288 tests (3 vials) - Store at -80°C or below ■ PeliKine Human IL-6 ELISA Rapid Set A 288 tests (1 box) - Store at -18 to -32°C ■ PeliKine Human IL-6 ELISA Rapid Set B 288 tests (1 box) - Store at -18 to -32°C Product Features ■ Frozen stored pooled donor PBMC (human pMAT cells) ■ Detects all types of pyrogenic substances that react with humans ■ No experimental animals required. Animal-free kit (human serum type) also available ■ Quantification of measurement results (calculated in pyrogenic activity EU/mL) Necessary Equipment and Related Products ■ Microplate reader with incubator (Nebula series) ■ Pyrogen-free dilution test tubes ■ Pyrogen-free 96-well microplates ■ WinKQCL software ■ Endotoxin testing water, tips * Lonza media (Iscove's Modified Dulbecco's Medium (IMDM): 12-722F) is required separately.
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For over 100 years, our company has provided high-quality hard capsules and unique formulation solutions to customers around the world as a leader in the industry. We have continuously aimed to be a partner in achieving business growth together by responding to your needs through high quality and unwavering trust, and by delivering innovative new products and services. "We believe that all our products and solutions exist for the growth of your business." This is our promise to you. Please look forward to the future of Lonza.