Extracellular Vesicles (EVs) as innovative drugs: large scale GMP manufacturing

Cardiac progenitor cells secrete exosomes, nanosized extracellular vesicles (EV) with anti-apoptotic and pro-angiogenic biological activities. These exosomes have been shown to prevent the chronic decline in cardiac function after myocardial infarction in preclinical rat models. The recognition of exosome-mediated effects has moved attempts at developing cell-free approaches for cardiac repair. Such approaches offer major advantages, including the fact that exosomes can be stored as ready-to-use agents and delivered to ischemic patients shortly after reperfusion of closed vessel. In a union of efforts of the Laboratory for Cardiovascular Theranostic and the Lugano Cell Factory of the Institute Cardiocentro Ticino, a GMP-grade method for the large-scale preparation of exosomes from cardiac progenitor cells as a medicinal product has been developed. The two groups brought their long-stand experience in EV large scale production and characterization into Marvel project.

During the first phases, Cardiocentro contributed to the definition of parameters for clinical performance, target marker candidates, auxiliary diagnostic criteria and potency tests, and supplied model EV samples to the partners.

In the next year, Cardiocentr Ticino will lead the validation of the process in the Lugano Cell Factory, the GMP certified facility for the development of Advanced Therapy Medicinal Products. The optimal system/support for affinity capture and release of EVs will be selected and a full GMP-grade manufacturing protocol will be validated.