Conventional stirred bioreactor systems are widely used in biopharmaceutical production due to their efficiency and early standardization. The development and evaluation of new bioreactor systems require a standardized workflow consisting of construction recommendations, process engineering characterization, and subsequent biological evaluation. Although process engineering parameters like mixing time, volumetric mass transfer coefficient, and specific power input are important for comparison, they provide limited information about the actual suitability of a system. In a case study, a novel bearing-free, magnetically driven 0.6 L benchtop bioreactor was developed and evaluated using this workflow. Biological evaluation with the model organism Escherichia coli in batch and fed-batch modes demonstrated the system’s suitability for microbial cultivations up to high cell densities. The results underscore the necessity of a multidisciplinary approach that considers both process engineering and biological aspects to determine the actual performance limits of bioreactor systems. The bioreactor concept developed with its bottom-mounted magnetic drive proved suitable for microbial applications.

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Standardized Process Engineering Characterization and Biological Evaluation of Stirred Bioreactors for Microbial Processes

  • Cedric Schirmer

摘要

Conventional stirred bioreactor systems are widely used in biopharmaceutical production due to their efficiency and early standardization. The development and evaluation of new bioreactor systems require a standardized workflow consisting of construction recommendations, process engineering characterization, and subsequent biological evaluation. Although process engineering parameters like mixing time, volumetric mass transfer coefficient, and specific power input are important for comparison, they provide limited information about the actual suitability of a system. In a case study, a novel bearing-free, magnetically driven 0.6 L benchtop bioreactor was developed and evaluated using this workflow. Biological evaluation with the model organism Escherichia coli in batch and fed-batch modes demonstrated the system’s suitability for microbial cultivations up to high cell densities. The results underscore the necessity of a multidisciplinary approach that considers both process engineering and biological aspects to determine the actual performance limits of bioreactor systems. The bioreactor concept developed with its bottom-mounted magnetic drive proved suitable for microbial applications.