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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.

Company secures $5M in funding to accelerate its rapid testing platformUSP<1223> Validation achieved, reinforcing 20-hour testing ...

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 ...

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 ...

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 ...

WASHINGTON (CN) - The Food and Drug Administration has amended the sterility test requirements for biological products. The FDA states that the new regulations are meant to provide manufacturers of ...

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 ...

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 ...