Scaling A mAb Production Process To A Single-Use Platform

The transfer of a monoclonal antibody production process between scales, often referred to as scale-up or scale-down, is a difficult task. Multiple scaling criteria exist to accomplish the necessary modifications, and intensive knowledge of physical characterization parameters for the bioreactors is required.

In this study, we have leveraged existing physical characterization data and scaled a process from microbioreactor scale to production scale in an Xcellerex XDR-1000 bioreactor. We show the physical operating parameters and present both cell culture and product quality data across all scales. The presented data sets demonstrate the scalability from microbioreactors to Xcellerex single-use bioreactors and across the XDR platform.