Revisiting CGT Manufacturing Strategy and De-Risking Tech Transfer

This segment of Cell & Gene Live, How CGT Developers Can Choose the Right Manufacturing Model for Their Pipeline, features Omkar Kawalekar, Ph.D., Manufacturing & Supply Chain Lead, Deloitte Consulting and Zoe Zheng, Executive Director, Pipeline Technical and Strategic Lead, Legend Biotech focusing on when CGT developers should start stress-testing manufacturing strategy, emphasizing that planning should begin as early as phase one and be revisited as clinical data, demand forecasts, and process knowledge evolve. The panelists then shift to tech transfer, where success depends on upfront alignment, comparability planning, risk assessment, and strong cross-functional ownership. The discussion also highlights warning signs of a weak process, including excessive manual work, operator dependence, and inconsistent batch performance across sites.