Scale-up is the process of transferring a biological manufacturing process from a smaller laboratory or pilot scale to a progressively larger production scale — such as from shake flasks to benchtop bioreactors and ultimately to commercial-scale bioreactors — while maintaining equivalent product quality, yield, and process performance. Successful scale-up requires careful engineering characterization of hydrodynamic parameters, mass transfer, dissolved oxygen, pH control, and agitation, and is a critical milestone in the process development and technology transfer workflow of any CDMO. It must be supported by comparability studies to demonstrate that critical quality attributes (CQAs) are preserved across scales.
