Diversifying Single-Use Technology With Cytiva XDR Bioreactors

AGC Biologics is a global leader in the use of single-use bioreactor systems, boasting the second-largest disposable bioreactor capacity in the industry. These bioreactors enable high-volume, rapid production of biopharmaceuticals, offering flexible configurations that allow developers to scale up production efficiently, from 2,000 L to 12,000 L, depending on the product stage and specific needs.

A key objective was to demonstrate that Cytiva's Xcellerex Disposable Reactors (XDR) could be integrated seamlessly into AGC's production process, performing just as effectively as the Thermo Fisher Single-Use Bioreactors (SUBs). This strategic move was critical in diversifying the supplier pipeline and addressing the increasing production demands, all while maintaining process integrity and product quality.

The challenge involved navigating both scale-independent and scale-dependent parameters. Scale-independent factors such as pH, temperature, dissolved oxygen, and viable cell density (VCD) needed to remain consistent across varying bioreactor scales to ensure process continuity. In contrast, scale-dependent factors, including volumetric mass transfer coefficient (kLa), tip speed, and power per unit volume, required careful calibration and monitoring. Moreover, transitioning to a new bioreactor brand introduced additional variables, such as differences in film composition, bag properties, and process regulation capabilities, which needed to be managed to ensure optimal outcomes.