MilliporeSigma has entered a collaboration with Solvias, a Swiss contract research and service provider, to offer the PyroMAT System, a new MAT kit for pyrogen detection developed collaboratively by the companies.
Pyrogen contaminations in pharmaceutical products, biotherapeutics and medical devices can induce life-threatening fevers and manufacturers must ensure that pyrogen concentrations do not exceed certain limits. The new PyroMAT System is a cell-line-based MAT kit that detects the full range of pyrogens in pharmaceutical raw materials and products.
“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. “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.”
According to the companies, the new kit eliminates the lab 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, chief executive officer, Solvias. “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.”