The downstream harvest, clarification, and purification operations of biologics are essential steps to ensure drug product safety. However, these process steps can be problematic for complex biologics. Compared with processes for traditional small-molecule pharmaceuticals, downstream methods for monoclonal antibodies (MAbs) have higher risks of contamination. Thus, different centrifugation, filtration, chromatography technology and viral clearance/inactivation strategies must be applied to remove dead cells, host-cell proteins, viruses, and other contaminants. Several factors must be considered to determine which methods and technologies are best for each downstream process. In this eBook, Shada Warreth, an author from Ireland’s National Institute for Bioprocessing Research and Training (NIBRT), reviews essential MAb purification methods and explores key considerations for harvest/clarification, ultrafiltration/diafiltration (UF/DF), and viral clearance steps. The primary challenge, Warreth shows, is to select downstream equipment and methods that work together, offer the best-fit option, and keep up with rising product titers and increasing complexities of cell-culture process fluids to be clarified, purified, and filled into final containers.
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