Challenges and advantages of cell therapy manufacturing under Good Manufacturing Practices within the hospital setting.

Details

Serval ID
serval:BIB_B35118F36861
Type
Article: article from journal or magazin.
Publication sub-type
Review (review): journal as complete as possible of one specific subject, written based on exhaustive analyses from published work.
Collection
Publications
Institution
Title
Challenges and advantages of cell therapy manufacturing under Good Manufacturing Practices within the hospital setting.
Journal
Current opinion in biotechnology
Author(s)
Iancu E.M., Kandalaft L.E.
ISSN
1879-0429 (Electronic)
ISSN-L
0958-1669
Publication state
Published
Issued date
10/2020
Peer-reviewed
Oui
Volume
65
Pages
233-241
Language
english
Notes
Publication types: Journal Article ; Review
Publication Status: ppublish
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.
Pubmed
Web of science
Open Access
Yes
Create date
24/07/2020 10:45
Last modification date
06/01/2021 6:25
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