Oral Presentation Australia and New Zealand Society for Extracellular Vesicles Conference 2023

Exosomes Purification - An integrated scalable solution to meet current and future manufacturing demands. (#37)

Jagan Billakanti 1
  1. Cytiva, Brisbane, QLD, Australia

A scalable workflow for purification of exosomes, a type of extracellular vesicles (EVs), is a major challenge for exosome manufacture. Exosomes are between 40-150 nanometre (nm) in diameter and downstream processing of exosomes includes removal of host cell proteins and DNA. At small scale, for R&D and diagnostic purposes, ultracentrifugation and density gradient separation are established technologies to enrich exosomes that are suitable. These technologies can however damage the exosome structure and hence reduce their biological function. As a result, these methods are unsuitable for the manufacture of therapeutic exosomes. The workflow described here is suitable for scale-up. It includes tangential flow filtration for concentration of exosomes followed by gentle size-exclusion chromatography (SEC) with a new SEC resin that is suitable for scale up and packing in large scale columns. In this presentation/poster we will demonstrate a start-to-finish exosome production process suitable for large scale production of exosomes harvested from three different cell lines. The data in this presentation/poster has been generated in collaboration with VivaZome Therapeutics Pty Ltd in Australia and at Cytiva R&D in Uppsala with exosome feed generated internally and kindly provided by Evox Therapeutics Ltd in the UK