Bioprocess decision support tool for scalable manufacture of extracellular vesicles.
costs
economics
exosomes
extracellular vesicles
manufacturing
scale-up
Journal
Biotechnology and bioengineering
ISSN: 1097-0290
Titre abrégé: Biotechnol Bioeng
Pays: United States
ID NLM: 7502021
Informations de publication
Date de publication:
02 2019
02 2019
Historique:
received:
15
02
2018
revised:
22
07
2018
accepted:
26
07
2018
pubmed:
1
8
2018
medline:
18
12
2019
entrez:
1
8
2018
Statut:
ppublish
Résumé
Newly recognized as natural nanocarriers that deliver biological information between cells, extracellular vesicles (EVs), including exosomes and microvesicles, provide unprecedented therapeutic opportunities. Large-scale and cost-effective manufacturing is imperative for EV products to meet commercial and clinical demands; successful translation requires careful decisions that minimize financial and technological risks. Here, we develop a decision support tool (DST) that computes the most cost-effective technologies for manufacturing EVs at different scales, by examining the costs of goods associated with using published protocols. The DST identifies costs of labor and consumables during EV harvest as key cost drivers, substantiating a need for larger-scale, higher-throughput, and automated technologies for harvesting EVs. Importantly, we highlight a lack of appropriate technologies for meeting clinical demands, and propose a potentially cost-effective solution. This DST can facilitate decision-making very early on in development and be used to predict, and better manage, the risk of process changes when commercializing EV products.
Identifiants
pubmed: 30063243
doi: 10.1002/bit.26809
pmc: PMC6322973
mid: NIHMS984196
doi:
Types de publication
Journal Article
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
307-319Subventions
Organisme : NHLBI NIH HHS
ID : R01 HL095722
Pays : United States
Organisme : Medical Research Council UK
ID : MR/K501256/
Pays : International
Informations de copyright
© 2018 The Authors. Biotechnology and Bioengineering Published by Wiley Periodicals, Inc.
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