Democratizing Cellular and Gene Therapies: Global Experiences in Point-of-Care Manufacturing

Chimeric antigen receptor T-cell (CAR-T) therapy represents a major advance in hematologic oncology, demonstrating high response rates and durable remissions in patients with relapsed or refractory malignancies, particularly B-cell leukemias and lymphomas and multiple myeloma. More broadly, cellular and gene therapies, including other engineered immune-cell platforms and gene-modified hematopoietic stem and progenitor cells, are expanding therapeutic possibilities across malignant and non-malignant diseases. To date, many of these therapies rely on centralized manufacturing models, in which patient cells are collected, shipped to specialized facilities for genetic modification and expansion, and then returned for infusion. While effective, this approach is resource-intensive, time-consuming, and vulnerable to logistical disruptions. These limitations have prompted growing interest in decentralized or point-of-care (POC) manufacturing, whereby cellular and gene-modified products are generated within or near the treating institution. Advances in automation, closed-system technologies, gene editing, and viral and non-viral gene transfer methods have made such models increasingly feasible. Early clinical experiences suggest that POC manufacturing can shorten turnaround times and improve flexibility, while maintaining product quality and clinical efficacy. As efforts expand globally, institutions across a range of healthcare systems are exploring POC approaches to address shared challenges in access, cost, and scalability. This evolving landscape provides a critical opportunity to evaluate diverse models, identify best practices, and inform future strategies for broader implementation of cellular and gene therapies.This Research Topic aims to address the persistent gap between innovation and access by exploring how point-of-care (POC) manufacturing of cellular and gene therapies can overcome these shared barriers in both high- and low-resource settings. Recent advances in cellular engineering, gene modification, manufacturing technologies, and evolving regulatory frameworks have made decentralized manufacturing increasingly feasible. Early clinical experiences suggest that POC approaches can reduce manufacturing and treatment timelines, improve treatment accessibility, and maintain high standards of safety and efficacy. By consolidating global experiences, this collection seeks to identify practical, scalable strategies for implementing POC cellular and gene therapy programs, fostering collaboration, and informing policy. Ultimately, the goal is to define pathways toward a more efficient, resilient, and equitable model for delivering cellular and gene therapies worldwide.Submissions may include original research, brief reports, reviews, and perspectives addressing, but not limited to:• Development and optimization of POC manufacturing workflows and platforms for cellular and gene therapies• Clinical outcomes and safety of POC-manufactured cellular and gene therapy products• POC manufacturing of CAR-T and other engineered immune-cell therapies, as well as gene-modified hematopoietic stem and progenitor cells• Comparisons between decentralized and centralized manufacturing models• Quality control, standardization, and regulatory considerations across jurisdictions• Cost analyses, reimbursement models, and health system integration• Operational challenges, including infrastructure, workforce, and supply chain• Technological innovations, including automation, closed and open systems, gene editing, and viral and non-viral gene transfer approaches• Multi-center collaborations and network-based manufacturing models• Ethical and policy considerations related to equitable accessBy bringing together experiences from around the world, including both high-income and resource-constrained settings, this collection aims to identify shared barriers, context-specific adaptations, and scalable solutions. Ultimately, it seeks to inform a more resilient and accessible model for cellular and gene therapy delivery, advancing the broader goal of democratizing these therapies on a global scale. Topic editors: Zaid Abdel Rahman, Fabio Giglio, Marcos De Lima, Vikram Mathews, Chuck Bailey Source: https://www.frontiersin.org/research-topics/80972/democratizing-cellular-and-gene-therapies-global-experiences-in-point-of-care-manufacturing