Spotlight: AAV manufacturing reality check: What broke at scale, what had to change, and what we’d design differently today

Early success doesn’t scale by default: Where AAV production processes that worked in preclinical and early clinical settings failed under scale, consistency or regulatory scrutiny and why assumptions had to be revisited.

Yield, purity and safety are inseparable: How upstream and downstream process choices directly influence empty/full ratios, impurity profiles and downstream toxicity risk.

CMC decisions with long tails: Which manufacturing and control decisions created friction later (comparability, validation, tech transfer)—and which changes most improved robustness.

Designing manufacturability in earlier: What this programme would now lock in earlier around process control, analytics and scalability to avoid re-engineering under time pressure.