Multicolumn chromatography offers several advantages over conventional batch chromatography, which includes improved productivity, resin and buffer utilization. The presentation describes a quick work flow for evaluation and optimization of multicolumn protein-A capture chromatography for clinical/commercial manufacturing process. The protocol was evaluated on three different antibody capture application. ‘Multicolumn protein A chromatography operation’ is compared with ‘conventional batch protein A chromatography operation’ for 2kL manufacturing scale-up requirements. Additionally, all key performance/quality attribute trend (e.g. yield, elution CV, elution pool pH, HMWP, HCP, HCDNA, LPA content etc.) were monitored during evalaution and compared with batch process.<br/>Continuous capture was observed to yield ~1.9-fold improvement in productivity when compared with batch chromatography; resulting in 35% to 39% commercial media savings and 43% to 48% clinical media savings across three different Mab’s. Implementation of ILC along and/or new generation protein A media along with multicolumn protein A chromatography can further improve the productivity by ~2-4fold.<br/>

Manufacturing strategies for Biosimilars: A case of continuous capture

2019 Spring National Meeting

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