HEK-293 cell lines have been widely used for over 35 years by the scientific community. Currently HEK-293 cells are the most efficient system for the improved production of ribosomal proteins and viral vectors by large-scale transfection of suspension-growing cells in serum-free medium. Also, it is the most established cell line for the production of adeno- and adeno-associated viruses, retro- and lentiviruses for gene therapy applications. Additionally HEK-293 cells sustain replication of many viruses that are evaluated as vaccines or viro-therapeutic agents. Consequently numerous viral vectors produced in HEK-293 cells have been approved for phase II and phase III clinical trials. In this presentation, major achievements in process developments completed at NRC to support the large scale manufacturing of viral vectors and vaccines using HEK-293 technology platform will be reviewed. In particular, we will discuss the development of REOLYSIN®, an oncolytic reovirus type 3 Dearing based therapeutic that is currently evaluated in phase III. The REOLYSIN® manufacturing process was scaled-up to a 100 L operation volume to support multicenter clinical evaluation. Advanced online monitoring tools allowed a very precise characterisation of viral infection and production kinetics to demonstrate process robustness, define critical process parameters and establish the process operating space according to the Quality-by-Design guidelines. Through different examples, the presentation will also discuss practises and experiences at NRC in supporting translational research and technology transfer.


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