Mesenchymal stem cells (MSCs) have been used extensively in cell therapy applications. In order to generate sufficient quantities of cells for clinical applications, MSCs must be transitioned from static 2D cultures to scalable suspension cultures grown in bioreactors. This transfer has traditionally represented a bottleneck.

This App Note demonstrates establishment of process control early in process development to overcome this bottleneck to help decrease development times and reduce COGs. Combined with automation, this approach facilitates transfer and scale-up in later stages of development by enabling the development of process insight and rapid identification and optimization of critical process parameters (CPPs).