Traditional sterility tests can take up to 14 days - far too long for life-saving drugs and cutting-edge cell and gene therapies, many of which cannot be tested using standard membrane filtration ...
Nelson Labs, a Sotera Health company and leader in microbiological testing, has expanded its rapid microbiological methods (RMMs) for product-sterility testing at three laboratory sites in the U.S.
The market presently operates under intense scrutiny following recent global regulatory updates. Laboratories are aggressively modernizing infrastructure to manage the record-breaking influx of novel ...
How rapid sterility testing can support a sterility assurance program. The current regulatory landscape for rapid sterility testing. Factors that impact implementation of a rapid test program. Nina ...
Currently established rapid methods for sterility testing of advanced therapy medicinal products (ATMPs) are mostly based on growth-based processes or the detection of metabolic activities. However, ...
Lee, MA, June 28, 2022 (GLOBE NEWSWIRE) -- Berkshire Sterile Manufacturing (BSM), a fill finish CMO located in Lee, MA, is proud to announce their sterility testing isolator is ready to perform onsite ...
Seoul National University College of Engineering announced that a research team led by Professor Sunghoon Kwon from the Department of Electrical and Computer Engineering, in collaboration with ...