Loading Events

« All Events

The 7th Annual Gene Therapy Analytical Development Summit

October 21 @ 8:00 am - October 23 @ 5:00 pm

The 7th Gene Therapy Analytical Development Summit is dedicated to advancing the analytical strategies required for next-generation gene therapies, which now extend beyond AAV to include mRNA, CRISPR-based platforms, and novel capsids. Given the increasing complexity of these evolving treatments and heightened regulatory demands, there is an urgent need for robust, forward-thinking solutions. The summit will directly address the rising pressure for analytical rigor, potency relevance, and product consistency, all of which are crucial for minimizing risk and maximizing product quality during development.

This year’s meeting, featuring expert insights from industry leaders, is designed to deliver practical, data-driven methods for validating critical assays, including those for potency and genome integrity analytics across diverse delivery platforms. Attendees will explore solutions for persistent challenges such as full/empty capsid quantification, aggregation profiling, and stability assay design. The summit will highlight strategies for aligning assays with regulatory requirements (IND, BLA, and RMAT), integrating advanced technologies like long-read sequencing and digital PCR into GMP-ready workflows, and overcoming the limitations of under-validated techniques that often slow down next-generation programs.

Details

Start:
October 21 @ 8:00 am
End:
October 23 @ 5:00 pm
Event Category:
Website:
https://www.genetherapy-analytical-cmc.com/

Organiser

Hanson Wade
Go to Top