Proceedings of the first academic symposium on developing, qualifying and operating a cell and gene therapy manufacturing facility

Abstract

A significant portion of the more than 1000 candidate cell and gene therapy products currently under clinical investigation (clinicaltrials.gov) are born out of academic research centers affiliated with universities, hospitals and non-profit research institutions. Supporting these efforts are myriad academic clinical materials production facilities with more than 40 such facilities currently operational in the United States alone. In March 2018, Stanford University's Laboratory for Cell and Gene Therapy held a symposium with the leaders and staff of more than 25 similar facilities to discuss the collective experience in developing, qualifying and operating cell and gene therapy manufacturing facilities according to current Good Manufacturing Practices. Topics included facility design, construction, staffing and operations and compliance. Leaders from several institutions gave overviews of the history of development of the facilities and discussed challenges and opportunities they had experienced over the past 10-20 years of operations. Working sessions were also held to discuss specific aspects of Process Development, Manufacturing, Quality Systems, Regulatory Affairs and Business Development with all participants contributing to the discussions. We summarize here the findings of this inaugural meeting with an emphasis on best practices and suggested guidelines for operations.