Successful bioprocessing relies on the ability to accurately and effectively monitor and control critical process parameters. The Mobius® CellReady 200 L single-use bioreactor is uniquely designed with the novel Mobius® Mobius® SensorReady technology, an external loop that enables configurable, flexible and functional monitoring and control. Bioreactor characterization properties such as mixing time, volumetric mass transfer capabilities, temperature mapping and power input define the process design space wherein accurate and effective monitoring and control can occur. Each of the aforementioned characterization properties were explored and evaluated for the Mobius® CellReady 200 L single-use bioreactor system.
Mixing studies were performed using conductivity probe response curves and comparing samples drawn from the Mobius® SensorReady module compared to samples drawn from the bulk liquid. Mass transfer capabilities were studied using the static gassing out method for determining the volumetric mass transfer coefficient (kLa) for oxygen and by the demonstration of CO2 stripping in live cell culture material using the microsparger and open pipe sparger, respectively. Heating and cooling capabilities were measured during ramp up and ramp down cycles, and power input was determined based on the wattages measured within the agitator motor box over varying agitation rates. In addition to physical characterization, cell culture capabilities were demonstrated with the execution of multiple cell culture process achieving peak cell densities > 20e6 cells/mL, with growth and metabolic behavior comparable to 3 L scale down controls. The results of these studies confirm that the Mobius® CellReady 200 L single-use bioreactor system is capable of supporting a wide range of biomanufacturing processes.