Allogeneic cell therapy bioprocess economics and optimization: downstream processing decisions.

AIM To develop a decisional tool to identify the most cost effective process flowsheets for allogeneic cell therapies across a range of production scales. MATERIALS & METHODS A bioprocess economics and optimization tool was built to assess competing cell expansion and downstream processing (DSP) technologies. RESULTS Tangential flow filtration was generally more cost-effective for the lower cells/lot achieved in planar technologies and fluidized bed centrifugation became the only feasible option for handling large bioreactor outputs. DSP bottlenecks were observed at large commercial lot sizes requiring multiple large bioreactors. The DSP contribution to the cost of goods/dose ranged between 20-55%, and 50-80% for planar and bioreactor flowsheets, respectively. CONCLUSION This analysis can facilitate early decision-making during process development.