Accelerate Your AAV Journey To IND And Beyond: Critical Insights On Some Tough QC Challenges

The therapeutic application of AAVs for Gene Therapy is progressing, but there are complexities, like evolving manufacturing approaches, changing regulatory expectations, and progressive discernment of Critical Quality Attributes. With potentially accelerated timelines and increasing market pressure, adoption of robust and comprehensive QC strategies is essential for ensuring product quality and safety and avoiding regulatory delays.

This webinar addresses QC topics that are crucial to consider when navigating regulatory complexities and optimizing development timelines, with specific regard to replication-competent AAV, viral clearance, and impurities impacting product quality.

In this webinar, you will learn:

• How to manage the challenges around determining the absence of replication-competent AAV (rcAAV)
• The key updates in ICH Q5A that discuss viral clearance for AAV products
• How NGS can provide broad characterization of targeted and non-targeted sequences in an AAV particle