Place of Academic GMP Facilities in Modern Cell Therapy

Academic medicine, in general, serves a dual role in advancing the scientific field as well as providing the highest quality clinical care. In the last decade we have observed significant development of commercial cell and gene therapy products with rapid growth of the industry. Currently, hospital-based Good Manufacturing Practice (GMP) facilities, which are used to support primarily academic investigator-initiated clinical trials, are increasingly involved in interactions with industry.The purpose of this piece is to review the role of academic GMP facilities in development of cellular therapies. For the purpose of this review we will discuss manufacturing facilities located in hospitals or academic medical centers and compare them with commercial GMP facilities. 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. Therefore, successful operation of an academic GMP facility requires striking a unique balance between commercial and academic priorities. Finally, we highlight some of the most challenging aspects of academic GMP facility operation and point to potential solutions.