2025 AIChE Annual Meeting

(362f) A Novel Modeling-Based Approach for Simulating Binding Capacity with a Single Breakthrough Curve for Continuous Capture Chromatography of Monoclonal Antibodies

Authors

James Hilton, Takeda Pharmaceuticals
The use of continuous chromatography for Protein A capture of mAbs and mAb-derived biotherapeutics is becoming more common to accommodate demands for higher throughput and cost of goods (COGs) reduction. 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. In-silico tools may offer a short cut for simplifying and accelerating SMB development. Here, we introduce an innovative experimental modeling approach for predicting the maximum binding capacity (MBC) and operating binding capacity (OBC) for continuous SMB chromatography. By utilizing a single breakthrough curve (BTC) per loading condition, this method offers a more efficient and cost-effective alternative approach compared to traditional models which require multiple BTCs. The model’s predictions were validated through experimental runs monitored using in-line PAT, reinforcing its potential for improving the efficiency of downstream processing in the biopharmaceutical industry.