Nina Moreno, Nelson Labs, explains how rapid sterility testing is reshaping pharmaceutical quality control—cutting release ...
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 ...
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 ...
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 ...
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 ...
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.
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 ...
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 ...