Advancing Cell Therapy Manufacturing: Rapid Sterility Testing To Help Ensure Product Safety And Quality

Cell therapy products are susceptible to microbial contamination, making sterility testing crucial for product quality and safety. Traditional sterility testing methods are time-consuming, but the USP chapter <1071> outlines alternative, rapid methods like quantitative polymerase chain reaction (qPCR) for sterility testing. The Applied Biosystems™ SteriSEQ™ Rapid Sterility Testing Kit is a qPCR assay designed to detect bacteria and fungi in cell therapy product matrices within 5 hours. The study found that introducing a centrifugation step at the start of sample preparation can enable the removal of released DNA, reducing the potential for detection of DNA from lysed microbes in test samples. The SteriSEQ kit was able to quickly detect bacteria and fungi in complex cell therapy product matrices, detecting six species listed in USP chapter <71> within a limit-of-detection range of 10–99 CFU/mL using two different sample prep kits.