Studies were conducted to evaluate a new, all-synthetic depth filtration media comprised of silica and a charged polymeric component. The evaluation sought to demonstrate the enhanced ability of the new media to clarify post-Protein A, post low pH viral inactivation precipitate and soluble impurities (e.g. aggregate, host cell proteins (HCPs), residual Protein A) compared to benchmark cellulosic media. Representative proteins derived from mammalian cell culture were tested at two pH conditions. The studies additionally investigated the effects of clarification and soluble impurity clearance when specific depth filter characteristics were varied across their manufacturing specification ranges (e.g. %Silica, Layer Thickness, Water Permeability). In general, the new media was superior in performance to the existing benchmarks, specifically in reducing soluble impurities such as HCPs and aggregate, however in some cases reduced filter loads (g/m<sup>2</sup>) were observed. No discernable differences in impurity clearance or filter loads were observed when filter specifications were varied. However, increased silica leaching in certain filtrate samples was observed for the new filters, but forward processing that material through downstream polishing chromatography columns demonstrated adequate silica clearance.

Evaluation of a new all-synthetic depth filter media demonstrates improved clarification and soluble impurity clearance post-protein A and low pH viral inactivation

253rd National Meeting (2017)

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