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Background: Production and scale up of therapeutic extracellular vesicles (EVs) is currently limited by a lack of validated, reproducible and good manufacturing practice (GMP) compliant manufacturing processes. Culturing EV producing cells on plastic and EV purification using ultracentrifugation are inefficient processes that are not scalable.
Methods: We propose EVs production in stirred tank bioreactor pursued by the tangential flow filtration (TFF) method (100 KDa cut-off cassette membranes) to purify the EVs. Wild type EVs produced by HEK293T cells were cultured in suspension and on...