Selecting a Cell Engineering Methodology During Cell Therapy Product Development.
cell therapy
gene therapy
genetic engineering
manufacturing
product development
viral vector
Journal
Cell transplantation
ISSN: 1555-3892
Titre abrégé: Cell Transplant
Pays: United States
ID NLM: 9208854
Informations de publication
Date de publication:
Historique:
entrez:
20
5
2021
pubmed:
21
5
2021
medline:
15
12
2021
Statut:
ppublish
Résumé
When considering the development pathway for a genetically modified cell therapy product, it is critically important that the product is engineered consistent with its intended human use. For scientists looking to develop and commercialize a new technology, the decision to select a genetic modification method depends on several practical considerations. Whichever path is chosen, the developer must understand the key risks and potential mitigations of the cell engineering approach. The developer should also understand the clinical implications: permanent/memory establishment versus transient expression, and clinical manufacturing considerations when dealing with transplantation of genetically engineered cells. This review covers important topics for mapping out a strategy for developers of new cell-based therapeutics. Biological, technological, manufacturing, and clinical considerations are all presented to map out development lanes for the initiation and risk management of new gene-based cell therapeutic products for human use.
Identifiants
pubmed: 34013781
doi: 10.1177/09636897211003022
pmc: PMC8145581
doi:
Types de publication
Journal Article
Research Support, N.I.H., Extramural
Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
9636897211003022Subventions
Organisme : NIGMS NIH HHS
ID : T32 GM135141
Pays : United States
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