(184t) Unlock Bioprocessing Capacity: A Comparative Study Focused on Intensified Downstream Processes

In response to the swiftly evolving biologics landscape marked by a rapid development cycle and expansive market, the biopharmaceutical industry faces an imperative need to optimize manufacturing process for faster, cost-effective production. This study presents a comparative analysis investigating the downstream processing capability for higher-productivity cell culture harvest by assessing three distinctive purification trains. Among these, two adhered to widely-adopted approaches combining bind-and-elute chromatography with a flowthrough polishing step, while the third employed an intensified process with two flowthrough columns. All three processes effectively purified the product of interest from feed material, even in the presence of elevated aggregation. While subtle differences were observed for impurity removal, the attributes monitored during in-process steps remained consistent across the three processes. In addition, the study evaluated process modeling to further compare process performance. Notably, the intensified process outperforms the other two in terms of throughput and operational efficiency. These results underscore the need to integrate intensified downstream processing technologies in antibody production. These results offer a comprehensive comparative analysis shedding light on opportunities and challenges in contemporary intensified bioprocessing