Management of externally manufactured cell therapy products: the Mayo Clinic approach

Background: The rise of investigative and commercially available cell therapy products adds a new dynamic to academic medical centers; that is, the management of patient-specific cell products. The scope of cell ther-apy has rapidly expanded beyond in-house collection and infusion of cell products such as bone marrow and peripheral blood transplant. The complexities and volumes of cell therapies are likely to continue to become more demanding. As patient-specific "living drugs," cell therapy products typically require material collec-tion, product provenance, transportation and maintenance of critical quality attributes, including tempera-ture and expiration dates. These requirements are complicated by variations in product-specific attributes, reporting requirements and interactions with industry not required of typical pharmaceuticals. Methods: To manage these requirements, the authors set out to establish a framework within the Immune, Progenitor and Cell Therapeutics Lab, the Current Good Manufacturing Practice facility responsible for cell manufacturing at Mayo Clinic Rochester housed within the Division of Transfusion Medicine. The authors created a work unit (biopharmaceutical unit) dedicated to addressing the specialized procedures required to properly handle these living drugs from collection to delivery and housing the necessary processes to more easily integrate externally manufactured cell therapies into clinical practice. Results: The result is a clear set of expectations defined for each step of the process, with logical documenta-tion of critical steps that are concise and easy to follow. Conclusions: The authors believe this system is scalable for addressing the promised growth of cell therapy products well into the future. Here the authors describe this system and provide a framework that could be used by other centers to manage these important new therapies. (c) 2021 International Society for Cell & Gene Therapy. Published by Elsevier Inc. All rights reserved.