Advances in process monitoring tools for cell culture bioprocesses

Abstract

The productivity of cell culture manufacturing for biologics has increased momentously in the past decades. Increasingly, the process research efforts are devoted into improving product quality and consistency. Consistent process performance and successful implementation of quality by design practice requires well‐utilized process analytical technology. This review summarizes recent progress and current status of bioprocess monitoring. Many sensors for bioprocess monitoring have been available for decades while new ones, especially spectrometric sensors, are making their way into cell culture bioprocesses. On‐line sampling devices have grown mature in the past decade thus making many instruments traditionally used for off‐line analysis available for at‐line use. With a general trend of using better defined medium for cell cultivation and increasing emphasis of process analytical tools, the spectrometric methods are also making headway in cell culture process monitoring. The integration of those sensing technologies will be important to advance the real‐time monitoring of the state of cellular physiology for the control for process consistency and product quality.