A Rapid, Low-risk Approach for Process Transfer of Biologics from Development to Manufacturing Scale

Manufacturing of biologics commonly focuses on an upstream process with Chinese Hamster Ovary (CHO) cells in a production bioreactor. Before this can begin, scientists have to find the best culture parameters using shake flasks or mini bioreactors. They then transfer these parameters from the laboratory through different scales of bioreactor.

Typically, process transfer during scale-up involves transferring through several different pilot and manufacturing scale bioreactors and doing multiple iterations to optimize process parameters at each scale, all of which is expensive and can take many months. BioPAT^® Process Insights is a software tool that can be used to minimize the risks associated with conventional bioreactor scaling and design space exploration. The software combines scaling functionality with characterized bioreactor data to support consistent scale up between Sartorius bioreactors. This study shows it is possible to scale up a cell culture process from 15 mL through pilot scale and up to 2,000 L without affecting the process or product quality.