The bio-pharmaceutical world has moved drastically towards short-lived personalized cell and gene therapy products in recent years. With the new quality control requirements, several new rapid microbial detection methods have been developed. USP states, "The ability to detect contamination, in real-time, prior to the administration of the short life product may be considered more important than detection of a single colony-forming unit (CFU) in the product." However, the new methods strive to detect the holy grail of 1 CFU. Will this ever be possible, or is it even necessary? In this poster, we will present the first digital (droplet) PCR based approach for sterility testing which is intended for testing of cell and gene therapy products, elucidate the critical steps, and highlight the many benefits of this approach. We will address the handling of background signals of a bacteria digital (droplet) PCR experiment and explain how to clearly differentiate between the background and real positive signals. We will demonstrate how the groundbreaking digital (droplet) PCR technology allows a new level of precision in rapid sterility testing. We propose an open discussion on this advanced method and its potential for QC testing and release.
Müller-Scholz et al. (Thu,) studied this question.