(493i) Development of Simulated Moving Bed (SMB) for Continuous Capture Chromatography of Monoclonal Antibodies (mAbs) and Mab-Derived Proteins

Capture chromatography of monoclonal antibodies (mAbs) and mAb-derived proteins using Protein A is an expensive unit operation due to the high material cost of Protein A resin. Traditional batch mode processes the material using a large, single column. Simulated Moving Bed (SMB) is an alternative continuous chromatography method that can reduce resin volume and processing time through the use of smaller columns placed in series, maximizing resin utilization. Due to the SMB’s complexity, process optimization can be challenging when compared to traditional chromatography methods. In this study, we present the process development work in designing an optimized SMB operation for protein purification (breakthrough quantification using in-line PAT, binding capacity determination, flow rate optimization, etc.). An optimized process minimizing the number of columns and processing time was achieved, leading to increased productivity and similar or better product quality (PQ) when compared to batch mode. The result is a cost-effective affinity capture step that significantly improves one of the most critical steps in pharmaceutical manufacturing.