Potency assays are the ultimate gatekeepers of mRNA therapeutic quality – and they’re also one of the most scrutinized elements in FDA review. This workshop takes you inside the journey of potency testing from Phase 1 to commercialization, showing how exploratory readouts must mature into validated, mechanism-linked assays that regulators can trust.

Join to learn:

• Mapping how potency assays must adapt from broad exploratory readouts in Phase 1 to robust, validated, and mechanism-linked methods by Phase 3 to withstand FDA scrutiny and enable product approval
• Tackling assay design challenges – from custom reagents and large constructs to modified nucleotides and secondary structure – to build potency tests that accurately reflect therapeutic activity and reduce regulatory risk
• Evaluate key differences between cell-based and cell-free potency assays to understand their impact on GMP-readiness and deliver scalable, compliant potency testing that supports sensitivity, reproducibility, and clinical relevance across development stages
• Explore the influence of formulation and LNP type on expression readouts and assay performance, and how to adapt analytical strategies accordingly