A Risk-Based Approach To Plasmid DNA And mRNA Process Development

As mRNA and plasmid DNA therapeutics continue to reshape the biopharma landscape, early-phase development teams face a critical challenge: how to build robust analytical strategies without slowing down clinical timelines. This article explores the tension between process development analytics and phase 1 filling readiness, which offers a strategic, risk-based framework to help teams navigate both. Drawing on insights from analytical scientists across modalities, it provides actionable guidance for PD scientists, QC leads, and regulatory teams on scaling analytics appropriately—ensuring scientific rigor while avoiding unnecessary complexity.

Whether you're refining your early-phase strategy or preparing for clinical manufacturing, gain clarity on how to align operational realities with regulatory expectations.