The Need for an Unbiased Assay to Detect and Quantify Replication Competent AAV in Clinical Vector Products
Time: 4:00 pm
day: Day One
Details:
- Replication-competent AAVs (rcAAV) are gene therapy product-related impurities that could have associated safety risks for patients.
- Our data show that the cell-based method can result in significantly different results between testing facilities using different assay protocols. Moreover, we show that positive or negative results are highly dependent on the capacity of serotypes to infect the permissive cell line in vitro, which could be quite different from what is observed in vivo.
- An analytical method that allows the unbiased detection and quantification of rcAAVs was developed based on a multiplex digital PCR (dPCR) that targets 3 junctions specific to rcAAV genomes.
