Viral vector manufacturing: how to address current and future demands?
Cell & Gene Therapy Insights 2019; 5(S5), 949-970.
Viral vectors are required as gene delivery vehicles for cell and gene therapies that provide transformative options for previously intractable human diseases, including diverse genetic, immunologic, neurodegenerative, ocular, cardiovascular diseases, as well as cancer with notable commercial progress in the latter. Robust and cost-effective viral vector manufacturing presents a core challenge in commercialization of cell and gene therapies. In this article, we assess the suitability of current viral vector manufacturing technologies for upstream processing to respond to the anticipated surge in demand. Our focus is on adeno-associated virus (AAV) and lentiviral vectors (LV) and the dominant cell type used for manufacturing, human embryonic kidney (HEK) 293 cell lines. We leverage the outcomes of a conference workshop, literature and expert opinions to conclude that, although we expect to see a mix of production technologies in viral vector manufacturing: i) suspension-based upstream processes will become the industry standard; ii) a trend towards continuous bioprocessing approaches will transform the field in the next years as these production modes hold the promise of significantly reducing manufacturing costs.