A Quality-by-Design Approach to Upstream Bioprocess Interrogation and Intensification

Efficient biopharmaceutical process development relies on the Quality-by-Design (QbD) paradigm. QbD is a scientific, risk-based proactive approach to drug development that aims to have a full understanding of how the process and product are related. This knowledge is gained by process analytical technology (PAT). This application note describes the successful integration of external PAT with an Eppendorf DASGIP Parallel Bioreactor System using Eppendorf’s software DASware analyze. The aim was to optimize the performance of a Chinese hamster ovary (CHO) mammalian cell bioprocess.