A bioprocess decision support tool for scalable manufacture of extracellular vesicles

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, researchers from Harvard-MIT Health Sciences and Technology developed a decision support tool (DST) that computes the most cost-effective technologies for manufacturing EVs at different scales, by examining 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, they 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.

Technologies (e.g. L-10) currently preferred by cell therapy industry may not be the most economical to meet market demands (2500 doses/year)


Plots displaying the annual Cost of Goods (COG) for a range of different cell expansion technologies, showing the contributing different cost categories (Equipment, Consumables, Labor, and Quality Control) that lead to the overall COG. Different lot sizes (# doses/lot) were assessed with a fixed overall demand (2500 lots/year) to show it affects technology selection based on cost efficiency. Use of larger-scale planar vessels (e.g. L-40, cL-120) or SUBs (e.g. 20L, 200L) may further reduce cost of cell expansion when compared to the industry standard L-10.

Ng KS, Smith JA, McAteer MP, Mead BE, Ware J, Jackson FO, Ferreira L, Bure K, Rowley JA, Reeve B, Brindley DA, Karp JM. (2018) Bioprocess Decision Support Tool For Scalable Manufacture of Extracellular Vesicles. Biotechnol Bioeng [Epub ahead of print]. [abstract]

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