Abstract

Large Scale Manufacturing and Functional Assessment of Extracellular Vesicles

Heather Branscome, Post-Doctoral Scientist, George Mason University

The interest in extracellular vesicles (EVs) underlies a significant need for both the isolation of high quality EVs from large-scale batches and the development of industry standards for the characterization and quality control testing of EVs. While traditional methods, which include the use of ultracentrifugation and density gradients, are suitable for small-scale studies, the development of scalable and robust processes for the isolation of EVs is essential to meet the growing needs of the scientific community. Here, we report the large-scale isolation and characterization of functional EVs from both cancer cell lines and stem cells.  Collectively, we demonstrate our ability to reproducibly manufacture production-scale batches of high quality EVs from multiple different cell types.  Our EVs are of high yield, meet well-established quality control specifications, and are robust in maintaining size distribution, surface marker expression, and functionality in vitro.  Therefore, they can serve as ideal reference materials that can support a wide range of different EV-based research applications.