How Can the Manufacturing of Viral Vectors for Gene Therapy Benefit from Continuous Processing?

Continuous bioprocessing is facing an increasing interest in the production of glycoproteins by mammalian cells due to the possibilities of intensification leading to favorable capital expenditure and the control of the quality of the product of interest, among other things. The manufacturing of viral vectors for gene therapy by transient transfection is challenging and represents a bottleneck to deliver these therapies to the patients. We will recapitulate learnings from continuous processing for the production of glycoprotein and analyze how these could be applied for the production of viral vectors. We have explored how the benefit of operating the transient transfection with adherent HEK293 cells could be exploited and showed a proof-of-concept of a microcarrier-based continuous process in stirred tank bioreactors. In parallel, we have also developed a process based on high cell density suspension cells using an alternating tangential flow filtration device, ATF. We will discuss these approaches.