Abstract
In recent years, due to significant improvements achieved in upstream processing of monoclonal antibody (mAb) manufacturing, the focus on productivity and cost-effectiveness has shifted towards downstream processing. Protein A affinity chromatography has been widely employed as the capture step for mAb purification and serves as a key driver of economic efficiency on downstream operations. To enhance the purification process and alleviate manufacturing constraints while reducing costs, continuous processing, such as multi-column capture (MCC), has gained attention. This study aimed to establish and optimize the protein A MCC process and to evaluate it with traditional single-column capture mode. Through a series of verification runs, it was determined that there was no significant difference in yield and quality attributes across different loops. Furthermore, annual cost of goods (COGs) was evaluated with the conventional single-column batch process. The results showed that MCC process reduced operation cost by 18 % and almost doubled productivity in the specific scenario.
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