With an increasing number of antibody therapeutics in development and higher cell culture titers from intensified upstream processes, manufacturing batch sizes are smaller and more diverse. As a result, single-use multi-product manufacturing facilities provide flexibility necessary to meet the changing demands. Implementing a fully single-use manufacturing platform can be challenging as bead-based ProteinA resin chromatography affinity has anchored industrial production of antibody therapeutics. Similar to ProteinA resin chromatography, a single-use alternative must consistently deliver products of high quality with low impurity content across a wide variety of antibody therapeutics. These driving forces motivated us to evaluate PrtoeinA-derivatized Fibro, a single-use chromatography technology, to advance our manufacturing platform.<br/><br/>Bench scale purification studies performed across a range of monoclonal antibodies demonstrate simple adaptation of the current resin ProteinA process to the ProteinA Fibro chromatography. Current process steps, buffers, and chromatography skids are directly transferable. ProteinA Fibro chromatography, however, enables rapid purification of monoclonal antibodies by offering faster mass transfer, shorter cycle times, and longer utilization within a single batch. Higher binding capacity and longer lifetimes are critical to take advantage of the productivity benefits. At bench scale, we find these two metrics are consistent across various antibodies evaluated without comprising product quality or impurity clearance. There are some nuances when developing the bench-scale Fibro chromatography due to inherent faster flow rates, higher operating pressures, broader eluate peaks, and system hold-up volumes. Characterization of these differences across multiple antibodies led to small modifications in process parameters and methods to develop a platform FibroA chromatography process at bench-scale. While experience is limited to one antibody, we experienced a similar need to make small modifications of our process as we up-scaled to pilot scale. We expect the scale-up of a Protein A Fibro chromatography process to be slightly more challenging than that of a resin process, but it is feasible as a platform process since performance is predictable.

Bench-scale evaluations of ProteinA Fibro, a single-use affinity capture platform of the next-generation manufacturing process of antibody therapeutics

Macromolecular Chemistry: The Second Century

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ACS Spring 2020 National Meeting & Expo

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.