Sterility Testing For Cell Therapy Bioproduction Samples: SteriSEQ Rapid Sterility Testing Kit

The SteriSEQ Rapid Sterility Testing Kit developed by Applied Biosystems is a useful tool for ensuring the quality and safety of cell therapy products. It uses a probe-based quantitative PCR (qPCR) assay to detect bacterial and fungal species, identifying cell densities without cross-reactivity. The kit delivers results in under 5 hours and includes software for automated data analysis. It also provides a discriminatory positive control (DPC) and an internal positive control (IPC) to increase testing accuracy. The DPC reduces false positives due to cross-contamination, while the IPC ensures consistent performance. The kit comes in 100 and 50 reaction packs and includes support from a global network of specialists.

Thermo Fisher Scientific Inc. offers this kit along with real-time PCR systems and the AccuSEQ Real-Time PCR Detection Software, which complies with 21 CFR Part 11 and includes manual review tools for in-depth data analysis.