Chromatography is ubiquitous to therapeutic protein purification. When the protein is a monoclonal antibody (mAb), Protein A chromatography is used in the capture step to separate the product selectively from process impurities such as host cell proteins (HCPs), host cell DNA, viruses, charged variants, fragments, endotoxins and aggregates. Among the issues in resin-based Protein A chromatography is the low throughput associated with flowrate-dependent performance. In particular, diffusion limitations require resin columns to be operated with long residence times to achieve satisfactory binding capacities. Protein A membrane chromatography is a solution. Recent innovations in Protein A membrane chromatography have led to products with binding capacities on par with resin chromatography using residence times that are shorter by an order of magnitude or more. The objective of this study was to provide the first preliminary comparison of all commercial Protein A membranes in terms of dynamic binding capacity, regeneration-reuse performance, pressure-flow rate dependence, HCP clearance and elution peak volumes. We will also present models to elucidate the differences in elution peak volumes for membrane columns versus resin columns. This presentation will report findings from a comparison of Purilogics PurexaTM-A, Gore® Protein Capture Device, Cytiva HiTrapTM Fibro Prism A, and Sartorius Sartobind® A chromatography columns.

Comparative study of protein A membranes for the rapid purification of monoclonal antibodies

ACS Spring 2022

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