On May 7, 2025, rising Duke senior Deven Gupta presented data from a study he led in partnership with Clinical Pathology Chief Beth Shaz, MD, MBA, at the International Society for Cell Therapy (ISCT). The study is now published in the Journal of Translational Medicine.
Titled “Surveying Local CAR T-Cell Manufacturing Processes to Facilitate Standardization and Expand Accessibility,” the study focused on chimeric antigen receptor T-cell (CAR T-cell) therapies ̶ potentially curative therapies, which have shown significant promise in treating cancers and other diseases. They have traditionally been used to treat heme malignancies and are now being studied in solid tumor and autoimmune diseases. The study aimed to evaluate the landscape of CAR T-cell manufacturing at academic institutions globally.
Gupta’s study goal was to understand the current and near future landscape of local manufacturing of CAR T-cells. Existing manufacturing processes exhibit considerable variability, potentially affecting treatment consistency and patient outcomes. Currently, the FDA-approved CAR T-cells are centrally manufactured, have limited accessibility, and are expensive. He and Shaz surveyed national and international organizations and identified challenges with local CAR T-cell manufacturing. While centralized manufacturing models dominate, local decentralized approaches, including point-of-care production, are being explored to address logistical and access challenges.
The study findings revealed the importance of establishing quality control benchmarks and data reporting frameworks to improve product consistency and access to CAR T-cell therapies. Addressing barriers such as cost, infrastructure, and regulatory challenges through standardization efforts and international collaboration could significantly enhance the reproducibility, scalability, and accessibility of CAR T-cell therapies globally. Read the study in the Journal of Translational Medicine.
Gupta is pursuing a BS in biophysics, a BA in classical civilizations, and a health policy certificate. He began working with Shaz in the summer of 2024 through the Duke-Margolis Summer Experience Internship Program as part of the Margolis Institute for Health Policy.
In addition to serving as chief of Clinical Pathology, Shaz is a professor of pathology and deputy director of the Marcus Center for Cellular Cures at Duke University. She’s a member of the Duke Cancer Institute and Margolis Institute for Health Policy, past president of the Association for the Advancement of Blood & Biotherapies (AABB) Board of Directors, and a scientific member of Biomedical Excellence for Safer Transfusion (BEST Collaborative).