The therapeutic monoclonal antibody (mAb) processing is evolving toward process intensification that can offer increased productivity and improved economics without sacrificing process robustness. A semi-continuous downstream process linking purification / polishing unit operations in series can reduce or eliminate intermediate holding tanks and reduce overall processing time. Accordingly, we have developed a mAb  connected flow-through polishing template that include activated carbon, cation exchange, and anion-exchange chromatography.<br/>In this study, A fully-connected pool-less polishing with three flow-through technologies was evaluated, operating as a single skid to streamline and improve a mAb purification platform. Laboratory-scale pool-less processing was achieved without utilizing in-line pH adjustment and conductivity dilution based on the optimized single process parameter by 96-well plate screening. Two connected flow-through configurations of polishing steps were compared: a two-step process using anion exchange and cation exchange and a three step process using activated carbon, anion exchange and cation exchange chromatography. Laboratory-scale proof of concept studies showed comparable performance between the batch purification process and the pool-less process configuration. Three step polishing highly intensified the processes and provided higher process loading and achieved bulk drug specification with higher impurity clearance (&gt;95 %) and high overall mAb yield (&gt;95 %).<br/>

Fully connected flow-through polishing for monoclonal antibody purification

2019 Spring National Meeting

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