Understanding The CMC Regulatory Landscape For Cell And Gene Therapy Products

By Monica M. Commerford, Ph.D., Manager, Regulatory Affairs, Thermo Fisher Scientific

Cell and gene therapies can dramatically impact patients’ lives by providing a cure for a disease rather than a long-term treatment. In addition, many of these products are targeting rare diseases, leading to an increase in molecules following expedited approval pathways. These factors are driving the industry’s passion and motivation to gain a better understanding of the evolving regulatory guidelines for cell and gene therapies, in order to bring them to market faster. However, collaboration and communication between the industry and regulators is needed to commercialize these products without sacrificing quality.