Spotlight: The importance of making sound early decisions on the path to a GMP-ready AAV manufacturing process.

The uncomfortable truth: Where early CMC and manufacturing assumptions quietly inflated cost of goods as programmes moved toward later-stage development and why these issues only surfaced under scale pressure.

Autologous vs allogeneic: the real trade-offs: What this programme learned about labour, yield, throughput and logistics and how those realities reshaped modality strategy and long-term commercial viability.

Fixing cost upstream, not at launch: Which changes to process design, starting materials, automation and site strategy most materially shifted the COGS trajectory and which ‘optimisations’ made no real difference.

What we’d lock in earlier next time: The specific CMC and manufacturing decisions this team would make in Phase I/II today to avoid expensive re-engineering later.