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.
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Article info
Publication history
Published online: October 27, 2018
Accepted:
July 26,
2018
Received:
July 2,
2018
Identification
Copyright
© 2018 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.
