The harvest step in a monoclonal antibody downstream purification process removes biomass, particulates, and other material from the cell culture to generate a product stream suitable for purification by liquid chromatography. In a widely employed, two-step harvest process, coarse solids and intact cells are first removed using a centrifuge, and the resulting centrate is further clarified by depth and membrane filtration in series. Conversely, direct depth filtration has the potential to greatly simplify the overall harvest process by directly loading the cell culture broth on high-capacity depth filters and consequently removing the need for centrifugation. We evaluated this potential of direct filtration for multiple biopharmaceutical assets to understand the underlying mechanisms that define fouling and the resulting capacity limitations in these filters. In this presentation, we show how each of the individual filters contributes to the overall capacity of the direct filtration train, and how the capacity is affected by characteristics of the cell culture broth and process parameters, including enhanced upstream processes such as high cell density perfusion. Our findings highlight the limitations of direct filtration when implemented in large-scale, high cell density facilities. Ultimately, this increased understanding of the fundamental principles that govern depth and membrane filtration can aid in moving from a trial-and-error to a more predictive and methodology-based approach for harvest development.

Understanding fouling mechanisms of filters during the harvest of monoclonal antibody therapeutics

Macromolecular Chemistry: The Second Century

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ACS Spring 2020 National Meeting & Expo

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.