Protein A chromatography is very effective in separating impurities from monoclonal Antibodies (mAbs) and continues to be used as the capture step in majority of mAb purification process. However, the high cost of Protein A resins requires better utilization of its capacity or use of cheaper and comparable alternatives. In this work, Puridify’s platform FibroSelect material, which was functionalized with Protein A ligand, was evaluated. The FibroSelect material exhibits a structure that overcomes the diffusional and flow limitations of packed bed chromatography purification systems and the capacity issues of chromatography membranes.  The binding capacities of FibroSelect Protein A was found to be comparable to that of conventional Protein A resins, and these capacities were achievable even at very high flow rates, thereby increasing productivity by 10-20 fold. An extremely short residence time (sub-second) allowed multiple cycles (up to 60 cycles) to be performed on FibroSelect in the timeframe equivalent to one cycle on the conventional Protein A column. This enables the technology to be applied in a single column multi-cycle mode, whereby the lifetime of the unit is exhausted over a single batch process, thereby, improving the resin utilization significantly compared to a conventional single column process. The reusability of FibroSelect Protein A was evaluated, and it was found to have consistent product quality, impurity profiles, and run chromatograms over 200 cycles. In addition, the polishing step performed using anion functionalized FibroSelect units in the flow through mode, resulted in at least 2 log clearance of host cell protein while maintaining high recovery at significantly higher loading. The disposable format of this technology and the ability to perform 200 cycles in a very short time makes the FibroSelect membranes a highly economical, and a productive alternative to the conventional packed resin format, including the more expensive Protein A resins as well as other resin functionalities.<br/>

Evaluation of single-use FibroSelect technology for monoclonal antibody purification

253rd National Meeting (2017)

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