Accelerating AAV biosafety and characterization decisions with validated NGS workflows

Biosafety testing and product characterization for AAV-based gene therapies can take 6–8 weeks using conventional methods. This webinar presents two validated next-generation sequencing (NGS) workflows that reduce that turnaround to approximately 1–2 weeks, with quantified sensitivity, GMP-ready bioinformatics pipelines, and regulator-aligned reporting designed to support IND/BLA submissions and comparability packages.

Attendees will gain a practical understanding of how untargeted short-read sequencing and genome integrity profiling can be implemented within a GMP framework to strengthen CQA definition and reduce late-stage risk.