Why Yield Isn't King: Analytics & Tech Transfer Lessons with Forge Biologics CTO David Dismuke

What are the hidden operational mistakes early-stage drug developers make before ever selecting a CDMO?

In this episode of Out of the Lab, host Nicholas Crudele sits down with David Dismuke, Chief Technology Officer at Forge Biologics. Drawing on over 20 years of experience across both academic CDMOs, corporate CDMOs, and therapeutic developers, David breaks down why yield should not be your only metric, how host cell DNA and empty/full ratios impact clinical timelines, and why a low-CV potency assay is your ultimate insurance policy during tech transfer.

In this episode, we cover:

• The Yield Trap: Why focusing solely on viral titer masks critical quality attributes (CQAs) that can derail regulatory filings.

• Empty vs. Full Capsid Ratios: Managing host cell DNA trade-offs and understanding route of administration impacts.

• Potency Assays as Comparability Anchors: How high-throughput, sound analytical methods allow you to innovate safely in GMP environments.

• Two-Sided Tech Transfer: Why you should never "throw the process over the wall" and how to execute proper gap analyses with your CDMO.

• Single-Use Equipment: Navigating downstream chromatography hurdles and eliminating multi-product contact risks.