Autologous and personalized cell and gene therapies (CGTs) are at the frontier of modern medicine, offering potential cures for previously untreatable conditions. However, scaling these therapies presents complex challenges distinct from traditional pharmaceuticals. Manufacturing requires managing multiple small, patient-specific batches, leading to issues such as high costs, time-sensitive processes, and regulatory scrutiny, alongside demands for precise data management and traceability. To address these challenges, organizations are adopting digital strategies that include intelligent automation, real-time monitoring, and AI-driven process optimization. Emerson’s white paper, “Digital Excellence for Advanced Therapies,” provides valuable insights into digital transformation, showcasing methods to build scalable and compliant CGT manufacturing environments, reduce batch variability, and accelerate delivery to patients, ensuring effective regulatory compliance.