Futureproofing AAV Processes: Viral Safety Considerations In Process Development

AAV manufacturing presents unique viral safety challenges due to limited opportunities for classical virus clearance approaches, and the increasing vector doses required for clinical efficacy. This presentation outlines an integrated approach to viral safety spanning development through commercial readiness for AAV programs. We first evaluate cell culture media virus filtration as a proactive barrier against adventitious contaminants. Later, we examine downstream viral safety through high‑resolution anion exchange (AEX) chromatography. Together, these studies illustrate how integrated filtration and chromatography strategies can be intentionally designed to manage viral risk throughout AAV process development. By embedding viral safety considerations early, AAV programs can progress from early development to reliable, regulatory‑compliant GMP production.