By Franziska Janke, Lars Kober and Robert Glaser
Scaling up bioprocesses, from small scale development to pilot and production scale, is a fundamental part of process development in the biopharmaceutical industry. To replicate process performance while increasing workload, the optimal cellular environment must be replicated.
Scale-up is often accompanied by process transfer to bioprocess systems with other properties, such as different geometries and engineering parameters. Depending on the scaling strategy, parameters such as mixing time, oxygen transfer and power input must be taken into account. Since it is usually not possible to retain all parameters when scaling up, bioengineers must evaluate which are the most critical. Among the most important aspects of scaling are oxygen mass transfer and dissolved oxygen (DO) concentration in the culture medium. Oxygen mass transfer depends primarily on the air sparge system, gassing rate, oxygen concentration, impellers selected, their settings, power input, and gas dispersal properties.
In this study, we scaled a CHO cell culture bioprocess from 1 L using a DASGIP® parallel bioreactor system to 5 L using a BioFlo bioprocess control station. ® 320. To develop a scaling strategy, we partly compared the power number and the volumetric mass transfer coefficient (kLa) of the bioreactors. The results show that the kLa value can be used as a suitable scaling criterion from small to laboratory scale.
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