Bioreactor for Scale-Up: Process Control

Abstract As human mesenchymal stromal cell (MSC) therapies move into late-phase clinical trials and commercial manufacturing for large indications such as stroke, acute myocardial infraction, etc., the need to manufacture large quantities of cells at a high quality and acceptable cost becomes critical. To date, the use of bioreactor culture—which combines process control, up-scalability, and automation, and which reduces deviations and cost—is the primary solution to these needs. In this chapter, various considerations and guidelines regarding the use of bioreactors for MSC culture are discussed, including scale-up considerations, process control, and comparability considerations.