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, ...

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 US Food and Drug Administration (FDA) is announcing its amendment of existing sterility test requirements for biological products, which it said will provide greater flexibility for manufacturers ...