Extracellular vesicles (EVs)-based therapeutics are based on the premise that EVs shed by stem cells exert similar therapeutic effects and these have been proposed as an alternative to cell therapies. EV-mediated delivery is an effective and efficient system of cell-to-cell communication which can confer therapeutic benefits to their target cells. EVs have been shown to promote tissue repair and regeneration in various animal models such as, wound healing, cardiac ischemia, diabetes, lung fibrosis, kidney injury, and many others. Given the unique attributes of EVs, considerable thought must be given to the preservation, formulation and cold chain strategies in order to effectively translate exciting preclinical observations to clinical and commercial success. Researchers from the Hudson Institute of Medical Research summarize current understanding around EV preservation, challenges in maintaining EV quality, and also bioengineering advances aimed at enhancing the long-term stability of EVs.
Workflow summary of EVs production for clinical use
Schematic of the development of EV therapeutics from preclinical testing to scalable bioprocesses including (A) development of large scale manufacturing of clinical grade EVs through various types of bioreactors, (B) characterization, quality analysis and content screening including factors involved in immunomodulation, angiogenesis, regeneration, tumor antigen presentation, (C) preservation in appropriate storage conditions to maintain the stability and integrity of these factors to meet clinical-scale demands.