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, ...

Robust sterility testing is essential to ensure the safety of cell therapies. However, traditional culture-based analysis takes several weeks to confirm a therapeutic’s microbial contamination, which ...

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 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 ...

BOCA RATON, Fla.--(BUSINESS WIRE)--LGM Pharma, a leading provider of tailored API and CDMO services for the full drug product lifecycle, announced today the expansion of its Analytical Testing ...

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 ...