Analytical Technology in Cell and Gene Therapy

Overview

The persistent analytical technology gap in cell and gene therapy — where product characterization tools lag far behind the biologics space — drives regulatory delays via complete response letters, perpetuates the process-freeze problem, and must be resolved alongside automation for the field to achieve commercial viability. At Prime Medicine, the analytical group was at one point larger than the biomanufacturing group — reflecting that analytical capability, not bioprocessing throughput, is frequently the binding constraint in advanced therapy development — and many complete response letters and regulatory delays trace back to analytics deficiencies rather than bioprocessing failures. The biologics space has in vitro developability assays that prospectively predict manufacturability and potentially potency, a capability cell and gene therapy is described as far from having — meaning the industry cannot yet characterize which candidates will be manufacturable at scale before committing to expensive clinical investment. (Segment 3 (10:00-15:00))