Abstract

Production of Extracellular Vesicle Reference Materials

William G Whitford, Strategic Solutions Leader, GE Healthcare Life Sciences

Applications for extracellular vesicles range from disease prognosis, to vectors of therapeutic cargo, to use as biomarkers for health and disease, to the support of clinical or companion diagnostics. There are ongoing efforts to standardize clinically applied vesicle assays. Reference materials, controls, and performance standards need to be defined for quality assurance in such assays. Certified reference materials (such as from the NIST or ATCC) and secondary materials will need to be generated for CLEA regulated diagnostic activities. Sponsors often have their choice of cell platforms, production formats and culture modes for vesicle product and process development. However, commercial success can be dependent upon the discovery of scalable technologies that can produce very large amounts of sufficiently pure and stable vesicles in a robust, compliant and cost-effective manner in a cGMP environment. The value of single-use manufacturing and continuous processing with chemically defined animal product-free materials will be reviewed.