Overcoming Regulatory Hurdles In AAV Production

For viral vector production, regulatory agencies like the FDA are placing greater emphasis on the total clearance of residual reagents used during upstream processing. These requirements often introduce significant hurdles, as demonstrating purity is essential for safety and quality assurance. Addressing these challenges requires a shift from reactive compliance to proactive quality control.

This session breaks down the methodologies required to quantify these residuals with high precision, ensuring that quality assurance aligns with current manufacturing rigors. By exploring the integration of tailored assays into existing workflows, technical teams can simplify the documentation process and fortify their compliance strategy. Understanding these analytical advancements is essential for maintaining momentum in viral vector development. Watch the presentation on demand to learn how to bridge the gap between complex production and successful regulatory approval.