Process development in biomanufacturing is costly and time consuming. Bioreactor scale-down models can enable process development to be conducted across multiple conditions at a practical and economical scale as small-scale vessels are amenable to automation and permit high-throughput experimentation. However, they typically have alternative geometries to the large-scale vessels used for manufacture, resulting in different fluid behaviour, mixing and gas transfer - all critical to bioprocessing.
Whilst it is intuitive to appreciate these changes, they're often difficult to predict. Consequently the use of scale-down models as accurate, robust, reproducible process development tools can be very challenging.
In this paper we explore how a systematic, robust approach can address the challenges of accuracy and reproducibility within scale-down models.
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