Ficolin-MASPs in complement and coagulation pathways

Abstract

Technologies suitable for the harvest clarification of cell cultures have experienced significant advancements in recent years. These advancements are motivated in part by increased cell densities and impurity levels, widespread industry adoption of single-use technologies, evolving regulatory landscapes, and a resurgence of perfusion cell cultures for continuous processing. This chapter details the major recent developments in the field of harvest clarification and includes discussions of core methods as well as emerging technologies. Core solid/liquid separation technologies such as centrifugation and depth filtration remain as cornerstones for the clarification of batch and fed-batch processes while microfiltration processes are being adopted for perfusion processes. Legacy methods, such as centrifugation have also advanced to incorporate new bowl designs for high density cell cultures, and process modifications have been made to improve product quality. Scale-down models for replicating shear and separation efficiencies have been reported. Recent developments for depth filters include new encapsulated devices, multistage depth filtration, and all-synthetic depth media grades. Tangential flow filtration and alternating tangential flow microfiltration methods are being adopted for high cell density perfusion processes. Recent developments in the areas of cell culture pretreatment and flocculation technologies, particle size characterization, and indirect analytical methods will also be discussed.