At the Borderline of Sensitivity and Noise
Authors: Lisa Hollstein, Miriam Dormeyer, Robert Hertel, Alexandra Müller Scholz | Last updated: September 2023
The bio-pharmaceutical industry has seen a significant shift towards personalized cell and gene therapy products in recent years. This shift has brought about new quality control requirements and the development of several rapid microbial detection methods. USP <1071> emphasizes the importance of real-time contamination detection prior to the administration of short-life products. However, the new methods strive to detect the "holy grail" of 1 CFU (colony-forming unit). The question arises, will this ever be possible, or is it even necessary?
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In this poster, we will:
Walk you through state-of-the-art nucleic acid detection, explaining the critical steps involved.
Address key requirements such as the limit of detection and how to handle "false" positives.
Highlight the many benefits of this approach.
Share our findings from the quantification of the positive control (PC) of our Microsart® ATMP Sterile Release Kit, which sheds light on the borderline between sensitivity and noise.
Propose an open discussion on this advanced method and the importance of understanding standards in QC testing and release.
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