New Synthetic Adsorptive Depth Filtration Media for the Primary and Secondary Clarification of Mab from CHO-S Harvests

We report the design and performance characteristics of a synthetic depth filtration media that demonstrates a greatly improved filtration capacity and decreased effluent turbidity for the clarification of mAb from CHO-S harvests.  This new depth filtration media is constructed entirely from synthetic components, which include a silica-based filter aid, acrylic fibers, and a charged polymeric binder resin.  When compared to commercial depth filtration media comprising mixtures of diatomaceous earth and cellulose, the synthetic depth filter media is shown to have greatly decreased organic extractibles and reduced WFI flushing requirements by TOC analysis.  The synthetic depth filter media also presents a significantly increased filtration capacity versus the commercial benchmark due to the incorporation of a pre-filtration layer.  As an added benefit, the silica filter aid is shown to impart a modest HCP clearance capability through an adsorption mechanism.  The impact of HCP clearance on downstream process purification steps is briefly explored.