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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.

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 ...

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

SALT LAKE CITY, March 04, 2025 (GLOBE NEWSWIRE) -- Nelson Labs, a Sotera Health company (SHC) and a global leader in microbiological and analytical chemistry testing and advisory services for the ...

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 ...

In this webinar, you’ll learn about a new fast-tracked, instrument-based biological indicator sterility test — and test service — designed for medical device and pharmaceutical manufacturers. It's ...

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, ...

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 ...