Roundtable Discussion: Translating Potency into Process Insight: Integrating Analytical Readouts to Strengthen mRNA CMC Decision- Making

  • Examining how potency assays can evolve from endpoint measurements to actionable tools, enabling deeper process understanding and more confident development decisions
  • Addressing challenges in maintaining meaningful, phase-appropriate potency readouts as mRNA products progress from early development through IND-enabling workflows
  • Exploring strategies to integrate analytical data with process parameters, supporting improved product consistency, faster iteration, and more robust CMC progression