Challenges and advantages of cell therapy manufacturing under Good Manufacturing Practices within the hospital setting
Emanuela M. Iancu, Lana E. Kandalaft
Abstract
Academic medicine serves to advance the scientific field and provide the highest quality of clinical care. This applies to cancer where there is a continuous unmet need for innovation. In the last decade, we have observed a significant development of commercial cell and gene-therapy products with a rapid growth of the industry. Hospital-based Good Manufacturing Practice (GMP) facilities which support primarily investigator-initiated clinical trials, are increasingly involved in interactions with industry. Although the missions of academic and commercial GMP facilities are different, both are bound by industry standards and often engage in technology transfer with industry partners. The successful set-up of an academic GMP facility requires striking a unique balance between commercial and academic priorities. Here we review the role of academic facilities in the development of cellular therapies with a focus on cancer immunotherapy and we highlight some of the most challenging operational aspects and point to potential solutions.