Kongressdetails

Maria Kamari

+1 617 455 4188

As gene therapies evolve beyond AAV to include mRNA, CRISPR-based platforms, and novel capsids, analytical strategies must advance in parallel to meet rising complexity and regulatory expectations. With increased pressure for analytical rigor, potency relevance, and product consistency, the need for robust, forward-thinking solutions is more urgent than ever.

The 7th Gene Therapy Analytical Development Summit returns to Boston this October as the industry’s most comprehensive event dedicated to analytical excellence across the gene therapy development lifecycle-from early research through to BLA submission and commercial readiness.

This year’s summit will deliver practical, data-driven insights on validating potency assays and genome integrity analytics across diverse delivery platforms to ensure consistency, safety, and regulatory compliance. Attendees will explore solutions to persistent challenges in full/empty capsid quantification, aggregation profiling, and stability assay design, focusing on enhancing product quality and minimizing batch failures.

With expert insights from Spark Therapeutics, Novartis, Sarepta, Astellas, Beam, Regeneron, Eli Lilly, Bristol Myers Squibb, and more, this is the must-attend meeting for those advancing gene therapy analytics.

Key highlights include:

- How companies are aligning assay strategies with IND, BLA, and RMAT requirements to meet regulatory expectations and speed up development timelines

- The integration of tools like long-read sequencing, mass photometry, analytical ultracentrifugation, and digital PCR into GMP-ready, QC-compatible workflows

- Real-world strategies to overcome limitations of under-validated techniques that are slowing next-generation programs

Time: 8:00 AM - 5:15 PM