As gene therapies rapidly evolve beyond AAV to encompass platforms like mRNA, CRISPR, and novel capsids, analytical strategies must advance concurrently to manage rising product complexity and stringent regulatory expectations. Addressing this crucial industry need, the 7th Gene Therapy Analytical Development Summit is returning to Boston this October. With increasing pressure for analytical rigor, reliable potency relevance, and product consistency, the demand for robust, forward-thinking solutions to manage development risk has become more urgent than ever for companies operating in this space.

This summit will provide practical, data-driven insights on key challenges, including how to validate potency assays and genome integrity analytics across diverse delivery platforms to ensure consistency, safety, and regulatory compliance. Attendees will explore solutions for persistent issues such as full/empty capsid quantification, aggregation profiling, and stability assay design, all focused on enhancing product quality and minimizing costly batch failures. Featuring experts from leading companies, the agenda will also cover integrating advanced tools like long-read sequencing and digital PCR into GMP-ready workflows, and strategizing assay alignment with crucial IND, BLA, and RMAT requirements.