White Papers

Practitioner perspectives on viral vector CMC and the path to IND.

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.

White Paper · 01

When Platform Processes Break: CMC Realities of Manufacturing Novel Engineered AAV Capsids

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.

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White Paper · 02

Navigating the Path from Capsid Access to IND: A Sponsor-Side CMC Playbook for Early Gene Therapy Teams

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.

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More writing in progress. For early access to upcoming papers, get in touch.

Practitioner perspectives on viral vector CMC and the path to IND.

When Platform Processes Break: CMC Realities of Manufacturing Novel Engineered AAV Capsids

Navigating the Path from Capsid Access to IND: A Sponsor-Side CMC Playbook for Early Gene Therapy Teams

If something in here lines up with where you are, let's talk about it.