Spotlight: Engineering safety at scale: How next-generation AAV manufacturing is tackling yield, consistency and toxicity risk together

Why scaling AAV is still hard: The recurring technical bottlenecks seen across programmes—spanning upstream productivity, downstream resolution, analytics and batch-to-batch variability.

Manufacturing choices shape clinical risk: How process parameters, impurity control and analytical depth influence immune response and toxicity signals downstream.

From artisanal to industrialised AAV: What’s changing in production platforms, purification strategies and in-process controls to move AAV manufacturing toward true industrial reliability.

Building for comparability and change: How to design manufacturing systems that can evolve (dose, capsid, indication) without resetting the regulatory clock.