Effective sterility testing is a crucial component in the manufacturing of life-saving drugs and therapies, ensuring that ...
Drugmakers using a sterility assurance release program can take a pass on sterility testing of finished units, according to FDA guidance. In a parametric release program, a drugmaker's demonstrated ...
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 ...
A domestic research team has developed a technology that can complete sterility testing of pharmaceuticals in just one day. Previously it took two weeks (14 days) to check the results, but this ...
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, ...
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 ...
Nelson Labs, a Sotera Health company and a specialist in microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries, now performs ...
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.
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