Manufacturing Exosomes – A Promising Therapeutic Platform

Extracellular vesicles, in particular the subclass exosomes, are rapidly emerging as a novel therapeutic platform. However, currently very few clinical validation studies and no clearly defined manufacturing process exist. As exosomes progress towards the clinic for treatment of a vast array of diseases, it is important to define the engineering basis for their manufacture early in the development cycle to ensure they can be produced cost-effectively at the appropriate scale. University College London researchers hypothesize that transitioning to defined manufacturing platforms will increase consistency of the exosome product and improve their clinical advancement as a new therapeutic tool. They present manufacturing technologies and strategies that are being implemented and consider their application for the transition from bench-scale to clinical production of exosomes.

Downstream Processing of Stem Cells


Diagrammatic representation of the current laboratory-scale methods used for downstream processing of stem cell-derived exosomes (A). Crude conditioned media is concentrated using filtration and then ultracentrifugation methods are used to isolate exosomes on the basis of size and density. Future processing needs to be scalable and so tangential flow filtration (TFF), followed by affinity capture and final polishing steps, are most promising approaches for the delivery of high-purity exosome therapies (B).

Colao IL, Corteling R, Bracewell D, Wall I. (2018) Manufacturing Exosomes: A Promising Therapeutic Platform. Trends Mol Med [Epub ahead of print]. [abstract]

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