<br/><br/> With more than a thousand antibody therapeutics currently in clinical development, the demand for improved production and purification of this class of proteins has become evident. Over the past several years, significant progress has been made to increase upstream process titers, thus creating a strain on existing downstream purification technologies. Although implementation of continuous unit operations has provided some relief, downstream processing still presents a major bottleneck in the production of therapeutic antibodies. In this presentation, we will demonstrate an integrated downstream purification process to enable significant removal of critical impurities. Through use of these affinity resins that possess high dynamic binding capacities of greater than 60 g/L, we have obtained antibodies with increased purity while reducing overall process time. Furthermore, by using select additives during process chromatography, we demonstrate this process can be fine-tuned to enhance target antibody selectivity by removing host cell protein impurities and aggregates. When used in conjunction these technologies represent a highly efficient process to obtain monoclonal antibodies for use as therapeutics.

Downstream process intensification with novel chromatography resins for enhanced monoclonal antibody purification

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.