Commercial scale monoclonal antibody (mAb) purification schemes usually employ rProtein A for capture, followed by one or two polishing steps for the clearance of impurities. However, the product quality highly relies on process robustness and performance of the polishing step designed to remove product-related low and high molecular weight (LMW and HMW) species. Therefore, the development of highly efficient polishing chromatography is of utmost importance in overall process development, especially for commercial manufacturing scheme. In this presentation, rapid development of a CEX chromatography procedure will be discussed. Tools such as high-throughput screening (HTS) and Design of Experiments (DOE) were leveraged, which enabled a deeper understanding of molecule stability for the presence of LMWs and HMWs and suitability of CEX operations. The separation behavior of target molecule from LMWs and HMWs as well as other process-related impurities, and their effective clearance from the feed stream will be discussed.

Development of efficient cation exchange (CEX) chromatography to remove low and high molecular weight species for commercial manufacturing of a mAb

251st National Meeting (2016)

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