Standardized Qualification of Stirred Bioreactors for Microbial Biopharmaceutical Production Processes

An in 2016 published DECHEMA guideline concerning process engineering characterization and a new Escherichia coli model process were utilized for the qualification of two geometrically similar stirred stainless steel bioreactors (30 L and 100 L working volume). The achieved results demonstrate that performing an additional biological model process is a valuable complement to the process engineering characterization. Optical densities of 27 (100 L) and 39 (30 L) were reached in the batch cultivation process. Reaching desired product quantity and quality in fermentation processes is often dependent on the bioreactor performance. Therefore, standardized methods for a qualification procedure are needed. Beside the general process engineering characterization a new Escherichia coli model process is introduced.