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, ...

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 ...

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 ...

The 14-day turn around time of current compendial sterility testing is plainly insufficient for a wide range of crucial, life-saving drugs and therapies, including an increasing number of novel cell ...