Development of downstream processing options for the commercial scale purification of stem cell derived exosomes

Exosomes (or extracellular vesicles) are rapidly gaining momentum as a novel type of regenerative medicine. Exosomes are nano-vesicles in the size range of 20-150nm that are secreted by mammalian cell types (including stem cells). They can induce potent biological functions in surrounding target cells to induce effects that mimic those of the producing cell. These functions can be regenerative, immunomodulatory, anti-scarring and even anti-cancer depending on the state of the producer cell. Consequently, there is enormous potential to develop a range of function-specific products across a wide variety of indications similar to macromolecular blockbusters, but which extend beyond symptom management to produce curative outcomes. However, current methods for purifying exosomes have been based on technologies grandfathered in from the viral industry which are not suitable for large scale, high purity production but are robust enough to perform preliminary characterisation of the exosome population composition.Please click Additional Files below to see the full abstract.