The importance of rapid methods, particularly those designed to support microbiological practices, was made by Andrew Hopkins who is an Expert Good Manufacturing Practices inspector with the UK’s ...
Advancing microbiology QC in biomanufacturing requires new technologies, strong cross-functional practices, and collaboration ...
A team of researchers have developed a novel method that can quickly and automatically detect and monitor microbial contamination in cell therapy products (CTPs) early on during the manufacturing ...
Despite innovations in rapid microbiological methods the pharmaceutical sector has been slow to adopt the latest technologies; moreover, the approach to assessing the risks to products is too often ...
Advanced biologics and patient-specific therapies reduce opportunities for terminal sterilization, elevating proactive microbial risk control and integrating QC microbiology into CCS authorship, risk ...
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.
Nelson Labs, a Sotera Health company and a specialist in microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries, now performs ...
A sterility test for cell therapy products returns yes/no results within 30 minutes for a range of microbial contaminants. Such detection speed is the result of combining machine learning (ML) and ...
Rapid microbiological point-of-care tests can detect the viruses and less common (atypical) bacteria thought to cause respiratory infections like coughs, colds, sore throats and ear pain. These tests ...