Simplifying Downstream Processing: Innovative Solutions for Filtration and Chromatography

Downstream processing comprises critical unit operations for harvesting, purifying, and recovering target biomolecules for use as biopharmaceuticals. Tangential-flow filtration (TFF) has been a cornerstone technology in biomanufacturing, enabling precise, efficient separation and concentration of protein products. Capture and polishing chromatography steps ensure the safety of such products by separating target molecules from impurities and contaminants. Though important, such operations are known to be time and resource-intensive. To minimize production costs and enhance process economics, biopharmaceutical manufacturers must investigate novel solutions. In this special report, Mark Perreault and Adam Nelson of Repligen explore two solutions designed to simplify downstream processes: TangenX SC TFF devices and OPUS prepacked chromatography columns. 

First, Perreault highlights how TangenX SC technology minimizes setup and decommission times, improving the productivity of ultrafiltration and diafiltration (UF/DF) operations. In a brief case study on monoclonal antibody (mAb) concentration, TangenX SC devices also are shown to be cross-scalable with TangenX SIUS single-use TFF devices. Nelson then presents a case study in which downstream teams from Sanofi applied OPUS prepacked columns to enable continuous downstream purification of a mAb solution at pilot scale. Together, the chapters of this special report show how such technologies optimize process performance, increase ease of use, and ensure reliable scalability throughout downstream manufacturing.

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