Automating Cell and Gene Therapy Manufacturing for Scale

Cell and gene therapies (CGTs) have demonstrated transformative clinical potential, but manufacturing remains a major barrier to broader patient access. Highly manual, labor-intensive production processes limit throughput, introduce variability, and drive up costs, making it difficult to scale these therapies to meet growing demand. As the industry looks to expand access, there is increasing focus on how automation, robotics, and digitalization can enable more consistent, efficient, and scalable manufacturing without compromising the underlying biology. In this episode of Off Script, we spoke with Edwin Stone, PhD, CEO of Cellular Origins, about the core bottlenecks constraining CGT manufacturing and how automation is beginning to address them. The conversation explores why labor remains a dominant cost driver, how process variability extends beyond patient starting material into everyday manual operations, and what it takes to transition from fragmented workflows to fully integrated, robotic production environments. Stone also discusses the importance of preserving biological integrity during automation, the role of digital data capture in improving consistency and regulatory confidence, and more.