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

Détails

ID Serval
serval:BIB_B35118F36861
Type
Article: article d'un périodique ou d'un magazine.
Sous-type
Synthèse (review): revue aussi complète que possible des connaissances sur un sujet, rédigée à partir de l'analyse exhaustive des travaux publiés.
Collection
Publications
Institution
Titre
Challenges and advantages of cell therapy manufacturing under Good Manufacturing Practices within the hospital setting.
Périodique
Current opinion in biotechnology
Auteur(s)
Iancu E.M., Kandalaft L.E.
ISSN
1879-0429 (Electronic)
ISSN-L
0958-1669
Statut éditorial
Publié
Date de publication
10/2020
Peer-reviewed
Oui
Volume
65
Pages
233-241
Langue
anglais
Notes
Publication types: Journal Article ; Review
Publication Status: ppublish
Résumé
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
Oui
Création de la notice
24/07/2020 10:45
Dernière modification de la notice
06/01/2021 6:25
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