Next Generation digital PCR Technology for Sterility Testing of Cell and Gene Therapy Products Poster
Authors: Edoardo Prediletto1, Wei Wang1, Lisa Hollstein2, Robert Hertel2, Alexandra Mueller-Scholz2
1 Autolus, London, UK 2 Sartorius, Goettingen, Germany
Overview
Sterility testing is crucial for the release of cell therapy products, as microbial contamination can be fatal for recipients. The current compendial sterility test requires 14 days for most microbes to ultimately rule out any contamination. However, for cell-based therapeutics, particularly autologous cell therapies for critically ill patients, the time to result is a significant factor, to reduce the vein-to-vein-time.
In this poster, we will present the first digital (droplet) PCR-based approach for sterility testing which is intended for release of cell and gene therapy products, elucidate the critical steps, and highlight the many benefits of this approach. 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.
Document type: Poster
Page count: 1
Read time: 5 minutes
Key Takeaways
- Guarantees rapid and sensitive detection of a broad range of microbes (including all USP 71 relevant ones) in cell-based or short shelf-life products
- Time to result: Only a few hours
- Compatible with digital or digital droplet PCR master mixes
This Resource is Designed for:
- Cell and gene therapy companies working on quality control
Applications Supported:
Digital (droplet) PCR
DNA extraction