Cell culture process transfer requires a good understanding of the physicochemical conditions within a bioreactor. This includes the hydrodynamic environment induced by the agitator and the mass transfer capability of the spargers at different gas flow rates. Cell culture processes need to operate in a design space where the oxygen supply and carbon dioxide removal can match cellular metabolism. In addition, prohibitive high shear stress and high gas flow rates can create bubble damage or foaming issues and should be avoided. Identifying the boundaries of a design space for a robust process is difficult due to the extensive characterization data needed and the diversity of single use bioreactor design.
