Atherly Pennybaker, Sofia A Pezoa and Randall Alfano*
A vital step in the manufacturing of vaccines and viral vector-based cell and gene therapies is virus production. Historically, virus production relies heavily on undefined and highly variable raw material for cell-based platforms to be successful. Yet due to supply chain constraints, poor reproducibility, and safety concerns attributed to potential adventitious agents present in serum and serum-derived proteins, regulatory agencies have encouraged replacement of these components. Recombinant serum proteins, specifically albumin and transferrin, can successfully replace serum-derived proteins in the expansion of VERO cells and subsequent production of multiple virus types. Furthermore, recent successes have demonstrated that recombinant human serum albumin can serve as an effective excipient in final formulations for the stabilization of virus in vaccines. Collectively, chemical definition of both upstream and downstream processes provides numerous advantages and is essential given the importance of virus and viral vector production for clinical applications.
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