Can novel bioreactors improve the cost of goods of viral vectors?

Lentiviral and adeno-associated viral vectors make up the vast majority of gene therapy candidates for in-vivo and in-vitro applications. While effective for treating a range of debilitating diseases, they are also currently very expensive to produce, which hampers patient accessibility. While other biologics have been studied and optimized for several decades, viral vectors still suffer from relatively low titers, difficulty in scaling up and poor downstream recovery. A review of available technologies focusing on upstream solutions highlights that despite the development of randomly packed bed bioreactors for adherent cells and the move to suspension cell cultures in stirred tank bioreactors, technology design flaws hamper efforts to cost-effectively bring new therapies to the market. In this paper, the scale-X™ and NevoLine™ technologies are shown to provide conditions that support two to ten-fold increase in cell specific productivity for AAV and LVV relative to alternative technologies, which results in drug substance cost of goods reduction between −18% and −61%. Furthermore, increased titers, smaller footprint and reduced complexity could improve the efficacy of facility utilization.