As mRNA expands into CAR-T, gene editing, and dark genome–derived applications, existing manufacturing and analytical paradigms are being fundamentally challenged. This panel brings together experts to examine how RNA design, process control, and release strategies must evolve to support transient expression, non-canonical sequences, and highly specialised therapeutic use cases.

• Designing mRNA constructs for next-generation modalities, including CAR-encoding and dark genome-derived sequences, examining how transient expression, sequence complexity, and translation efficiency reshape expectations for manufacturability and control
• Defining fit-for-purpose analytical and release frameworks capable of verifying mRNA quality, potency, and delivery performance in the context of cell therapy batches, gene editing workflows, and novel genomic targets
• Identifying where current CMC and regulatory assumptions break down, and how developers can proactively de-risk programmes by adapting analytics, comparability strategies, and control concepts early