(511c) Evaluation of a Centrifugation Scale-Down System for Bench-Scale Process Development

Centrifuge process development and characterization require a vast amount of time and resources to adequately satisfy the requirements of today's Quality by Design driven process regulatory requirements. Currently, process characterization must be performed at pilot scale utilizing many bioreactors and multiple FTE's to produce the data to model manufacturing harvest processes. To reduce resources, it is desirable to perform development at bench-scale, however, a bench-scale batch centrifuge cannot model large-scale processes because of its inability to generate shear rates experienced in the feed zone of larger disc stack centrifuges. A shear device was developed and evaluated which can produce equivalent shear rates to the feed zones of large scale manufacturing centrifuges. When coupled to a bench scale centrifuge, large scale centrate streams can be mimicked, thus enabling small-scale process modeling and reducing the resources required for centrifuge development and characterization.