How rapid sterility testing can support a sterility assurance program. The current regulatory landscape for rapid sterility testing. Factors that impact implementation of a rapid test program. Nina ...
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 ...
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, ...
Emcure Pharmaceuticals has had its share of run-ins with the FDA in the past over the sterility of one of its Indian manufacturing plants. Now, it can notch one more black mark on its belt. The FDA ...