Biologic products cultivated in environments that pose diverse risks to product quality and safety require testing to mitigate the risk of contamination throughout the manufacturing process through to final drug product. Assuring the integrity and purity of your product during cell line characterization and cell bank release testing is integral to any viral safety strategy.
Traditional animal- and cell-based detection methods often fall short in turnaround time, sensitivity, and specificity in the identification of adventitious agents and viruses -- especially unknown viruses, leading to potential contamination risks. For short shelf-life products or those requiring rapid turnaround time for testing, such as cell therapy products, time to result is critical.
We have developed an NGS approach that focused on robust viral detection beyond the species level where available. This is complemented with a secure bioinformatics approach for rapid viral identification using a proprietary analysis platform comprised of multiple curated viral databases. This provides a tested pipeline, designed for speed, accuracy, and comprehensive virus databases for identification , while maintaining Good Manufacturing Practices (GMP) .
During this webinar, we will discuss: