Scalable Biomanufacturing Workflow to Produce and Isolate Natural Killer Cell-derived Extracellular Vesicle-based Cancer BiotherapeuticsFrederic St-Denis-Bissonnette *1,2, Melanie Kirkby *1,2, Lisheng Wang 2,3,4, Jessie R. Lavoie 1,2
1Biologic and Radiopharmaceutical Drugs Directorate, 2Department of Biochemistry, Microbiology and Immunology Institute, University of Ottawa, 3Centre for Infection, Immunity and Inflammation Institute, University of Ottawa, 4Regenerative Medicine Program, Ottawa Hospital Research Institute
Natural killer cell-derived extracellular vesicles (NK-EVs) hold promising potential as cancer biotherapeutics. This methodology-based study presents a scalable closed-loop biomanufacturing workflow designed to continuously produce and isolate large quantities of high-purity NK-EVs. In-process control testing is performed throughout the biomanufacturing workflow, ensuring the EVs meet quality standards for product release.
