Inside the IDMO model: Analytical comparability, regulatory readiness and operational excellence

More ex vivo cell therapy programs are expanding beyond rare diseases into autoimmune indications, bringing larger patient populations that demand commercial-scale manufacturing. That shift is pushing sponsors to face three converging risks: proving manufacturing comparability, navigating regulatory expectations, and scaling operations across global sites. This session brings together experts from Cellares to explore how automated platforms support analytical comparability, how early FDA engagement through the Manufacturing PreCheck Pilot Program reduces late-stage regulatory risk, and what it takes to operationalize consistent manufacturing standards across a global IDMO network.