We will present a framework for describing the performance of disc-stack centrifugation in conjunction with depth filtration and capture column chromatography for cell and impurity removal using controlled harvest conditions. In combination, data from bench/pilot-scale to large-scale operations will be presented evaluating the impact of controlled parameters on downstream performance.
Pilot-scale centrifugation and depth filtration studies were then performed at a wide-range of centrifuge flowrates and RPMs using optimized harvest from various clinical products producing IgGs. The data shows a significant reduction in centrate clarity compared to clarifying with unadjusted harvest streams at all scales, with improved post-centrifuge filtration capacity and capture column eluate purity and clarity. Overall, this analysis allows for improved future design and optimization of large-scale centrifugal operations for processing mammalian cell culture broths.