Field-tested writing from ten-plus years building viral vector and engineered AAV capsid programs from RUO through IND and first GMP supply. Written for the developers, founders, and investors who have to make these decisions in real time, on real budgets.
AI-designed and rationally engineered AAV capsids are unlocking biology that natural serotypes cannot reach. They also break the platform assumptions most early teams are quietly relying on. A practical look at where and why platform processes fail for novel capsids — and what to do about it before it costs your program a quarter.
Capsid access is the start, not the finish. The chain of CMC, manufacturing, and development decisions between capsid in hand and an IND submission is where lean teams either build momentum or quietly lose months. A sponsor-side playbook for sequencing those decisions on real budgets.
You have capsid access. Now what? A practical CMC guide for early-stage teams working with engineered capsids — manufacturability screening, material strategy, plasmid sourcing, CDMO selection, tech transfer, and writing Module 3 while the work is happening. Built around case studies where early CMC judgment saved months and runway.
More writing in progress. For early access to upcoming papers, get in touch.
