Developability

Overview

Drug design philosophy that evaluates manufacturability and scale-up potential from the earliest stage through iterative design-make-test-redesign cycles, treating process feasibility as a priority design criterion. Developability is an approach where manufacturability and scale-up potential are treated as priority design constraints from the earliest stage of drug development, addressing the vulnerability that occurs when molecules work brilliantly at bench scale but cannot be manufactured at the scale needed for the target patient population. Iterative design-make-test-redesign cycles applied during developability assessment generate early data on molecular variations that can be transferred to process development teams and then to manufacturing, enabling scale-up failure to be caught before it becomes a clinical program blocker. (Segment 3-4 (10:00-20:00))