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.

Safety and efficacy are the two regulatory benchmarks for pharmaceutical products. Microbial contamination of products is an important aspect of product quality that can affect both safety and ...

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, ...

A team of researchers have developed a novel method that can quickly and automatically detect and monitor microbial contamination in cell therapy products (CTPs) early on during the manufacturing ...

Advanced biologics and patient-specific therapies reduce opportunities for terminal sterilization, elevating proactive microbial risk control and integrating QC microbiology into CCS authorship, risk ...

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 ...

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

A sterility test for cell therapy products returns yes/no results within 30 minutes for a range of microbial contaminants. Such detection speed is the result of combining machine learning (ML) and ...

This is the first novel technology that utilises machine learning to analyse unique ultraviolet light “fingerprints” on cell cultures to quickly identify presence of contamination Only requiring 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 ...

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 ...

Company secures $5M in funding to accelerate its rapid testing platform USP Validation achieved, reinforcing 20-hour testing method Faster test results replace the standard 14-day USP sterility test ...