Abstract

Single-use Biomanufacturing of Extracellular Vesicle Reference Materials

William Whitford, Strategic Solutions Leader, GE Healthcare

Interest in microvesicles, exosomes and oncosomes is growing. Applications include 1) vectors of research or therapeutic cargo, 2) agents of intercellular communication from stems cells to terminally differentiated tissue  to the entire microbiome and 3) support of clinical diagnostics.  There are ongoing efforts to standardize clinically applied vesicle assays and therapeutic cargo vehicles.  Reference materials, controls, and performance standards need to be defined for quality assurance in such applications.  Certified reference materials (such as from the NIST or ATCC) and secondary materials may need to be generated for CLEA regulated diagnostic or therapeutic 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 vesicles in a robust, compliant and cost-effective manner in a cGMP environment.  In biopharmaceuticals, single-use processing  is demonstrating heightened process efficiency and flexibility, reduced contamination risks, lower initial facility investment costs and operating costs, educed classifications and utilities.  Continuous biomanufacturing additionally promises a reduction in product microheterogeneity;  construction costs and schedule extent; manufacturing suite area and  classification.  The value of single-use implemented continuous biomanufacturing with chemically defined animal product-free materials will be reviewed.