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.
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 ...
Sterility testing is crucial for Advanced Therapy Medicinal Products (ATMPs) such as cell therapies, as microbial contamination can be fatal for treatment recipients. The time to result is a ...
Preventing leaks and seal failures in sterile packaging is vital for patient safety. Learn how vacuum decay and airborne ...
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, ...
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 ...
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 ...
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 ...
Adventitious microorganisms—the bane of bioprocessing—may mingle with raw ingredients, light upon exterior surfaces, or settle into bioreactors. To deal with such organisms, bioprocessors need to ...
LONDON--(BUSINESS WIRE)--According to the latest report published by Technavio, the sterility testing market size is poised to grow by USD 1.02 billion during 2020-2024, progressing at a CAGR of ...
PCR-based bacterial and fungal detection helps scientists efficiently analyze the sterility of their cell cultures, improving Mycoplasma testing and beyond. Scientists turn to PCR-based methods that ...