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, ...
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 ...
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 ...
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.
Traditional sterility testing methods for the presence of bacteria and fungi in T-cell cultures are time-consuming, taking from seven up to 14 days, while this novel method takes only up to 24 hours ...
The global Pharmaceutical Isolator market was valued at USD 432 Million in the year 2024 and is projected to reach a revised size of USD 509 Million by 2031, growing at a CAGR of 2.4% during the ...
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 ...
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