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.

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 ...

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 ...

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 ...

ACROBiosystem's SAFENSURE ™ Sterility Rapid Detection Kit is a validated NAT-based sterility rapid detection kit designed to accelerate in-process and lot-release testing. The Sterility Rapid ...

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, ...

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 ...

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 ...

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 ...

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 ...