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 ...

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 ...

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, ...