Characterization Data for the Establishment of Scale-Up and Process Transfer Strategies between Stainless Steel and Single-Use Bioreactors

Abstract

The reliable transfer of bioprocesses from single-use bioreactors (SUBs) of different scales to conventional stainless steel stirred-tank bioreactors is of steadily growing interest. In this publication, a scale-up study for SUBs with volumes of 200 L and 2000 L and the transfer to an industrial-scale conventional stainless steel stirred-tank bioreactor with a volume of 15,000 L is presented. The scale-up and transfer are based on a comparison of mixing times and the modeling of volumetric mass transfer coefficients kLa, measured in all three reactors in aqueous PBS/Kolliphor solution. The mass transfer coefficients are compared with the widely used correlation of van’t Riet at constant stirrer tip speeds. It can be shown that a van’t Riet correlation enables a robust and reliable prediction of mass transfer coefficients on each scale for a wide range of stirrer tip speeds and aeration rates. The process transfer from single-use bioreactors to conventional stainless steel stirred-tank bioreactors is proven to be uncritical concerning mass transfer performance. This provides higher flexibility with respect to bioreactor equipment considered for specific processes.