Sterility testing remains a key bottleneck in the release of cell and gene therapy products (CGTPs), where current compendial methods require up to 14 days, delaying batch release and increasing costs. Symcel's calScreener+ is a novel, commercially available, phenotypic sterility testing system that enables continuous and non-destructive metabolic monitoring via isothermal microcalorimetry, delivering microbial detection results in under three days- offering the fastest reported time-to-detection (TTD) among currently available, growth-based sterility methods evaluated for CGTPs.To demonstrate system applicability, we will present application data showing microbial detection in the presence of high-density eukaryotic cells (106-108 cells/ml), without enrichment or sample processing. This illustrates the method's compatibility with complex, cell-rich matrices typical of CGTPs.The primary focus is validation data from the calScreener+ Three-Day sterility test, covering:Limit of detectionDetection times for fast- and slow-growing organismsSpecificity across 30 relevant microbial speciesComparability to compendial methodsRobustness and ruggedness under varied conditionsA brief overview of the assay workflow will also be included. This method enables earlier contamination detection and supports faster, more efficient batch release-representing a significant advancement for CGT manufacturing.
Paulander et al. (Thu,) studied this question.