CMC challenges in cell and gene therapy manufacturing

Michael Lehmicke, Senior Director of Science & Industry Affairs, Alliance for Regenerative Medicine, Washington, D.C., comments on some of the key chemistry, manufacturing and controls (CMC) obstacles in cell and gene therapy (CGT) manufacturing. The development process of CGT products from early-phase clinical trials to commercialization is complex and can lead to major regulatory delay, if it is not addressed early on. Although there have been improvements in the regulation of cell and gene therapies, guidance is still lacking in the late-stage development of CGT products.. This interview took place at Advanced Therapies Week 2022.