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The new kit is expected to detect a broad spectrum of pyrogens while offering high reproducibility and sensitivity as well as eliminating the need for live animal testing.
On May 29, 2018, MilliporeSigma, the life science business of Merck KGaA, Darmstadt, Germany, announced that it has entered into a collaboration with Solvias, a Swiss contract research and service provider, to offer the PyroMAT System, a new monocyte activation (MAT) test kit for pyrogen detection. The kit was developed collaboratively by the companies and expands MilliporeSigma’s pyrogen detection portfolio.
Pyrogen contaminations in pharmaceutical products, biotherapeutics, and medical devices can induce life-threatening fevers, thus manufacturers must ensure that pyrogen concentrations do not exceed certain limits. The new PyroMAT System detects the full range of pyrogens in pharmaceutical raw materials and products. It is the only cell-line-based MAT kit on the market, according to MilliporeSigma.
“Our new PyroMAT System has many advantages over existing methods, which are often limited in the products and range of pyrogens that can be detected,” said Jean-Charles Wirth, head of applied solutions at MilliporeSigma, in a company press release. “This system offers a high-quality, ready-to-use in vitro method that does not require live animal testing and detects the broad spectrum of pyrogens.”
The new kit eliminates the laboratory work required to maintain the cell line, and the cells are qualified in terms of performance and shipment.
“We are pleased that our collaboration with MilliporeSigma to distribute the cell-based test is now coming to fruition,” said Karen Huebscher, CEO, Solvias, in the press release. “The new PyroMAT System has significant potential through distinct advantages over current methods of testing for pyrogens. It produces results that are both reliable and reproducible, characteristics that are essential for quality assurance.”