Perfusion processes enable continuous operation over extended periods of time by constantly providing fresh nutrients for the cells and simultaneously removing spent media and waste products, as compared to batch and fed-batch processes. The key benefits of perfusion processes are compact process design, flexibility, increased productivity, increased yield, and consistent product quality.
The purpose of the described study is to demonstrate a connected mAb perfusion cell culture process using Xcellerex XDR 50 integrated with the Xcellerex Automated Perfusion System (APS). The process target was to achieve a cell concentration of 70 MVC/mL and a cell viability of greater than 90% for 10 days in a closed and connected process. In addition, the stretch goal was for the cell harvest to deliver a daily average IgG titer of 0.72 g/L to the harvest hold bag and maintain a Cell Specific Perfusion Rate (CSPR) of 20 pL/cell/day.