Premium
Bioprocess decision support tool for scalable manufacture of extracellular vesicles
Author(s) -
Ng Kelvin S.,
Smith James A.,
McAteer Matthew P.,
Mead Benjamin E.,
Ware Jamie,
Jackson Felix O.,
Carter Alison,
Ferreira Lino,
Bure Kim,
Rowley Jon A.,
Reeve Brock,
Brindley David A.,
Karp Jeffrey M.
Publication year - 2019
Publication title -
biotechnology and bioengineering
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.136
H-Index - 189
eISSN - 1097-0290
pISSN - 0006-3592
DOI - 10.1002/bit.26809
Subject(s) - consumables , risk analysis (engineering) , microvesicles , bioprocess , extracellular vesicles , scalability , computer science , scale (ratio) , biochemical engineering , process (computing) , business , engineering , chemistry , marketing , microrna , biochemistry , physics , database , chemical engineering , quantum mechanics , biology , gene , microbiology and biotechnology , operating system
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.