Monoclonal antibody (mAb) aggregation is one of the most critical risk factors for safety and efficacy of the therapeutics. However, aggregates are generated easily during manufacturing and storage steps and continue to be a major problem in downstream process development. Separation of soluble aggregates is most challenging when the aggregates have surface chemical properties similar to the monomer that can interact with resin including affinity chromatographic resin. In this presentation, we will show the impact of aggregate on the capacity and efficiency of chromatography steps such as protein A, ion exchange or HIC (hydrophobic interaction chromatography) columns. As titer from upstream increases, capacity of the resins is more of importance and impurities such as aggregate reduces the binding capacity of monomer significantly. We will also demonstrate efficient removal of mAb aggregates by utilizing additives and highly selective chromatography media which results in increase in process throughput and product purity.

Impact of mAb aggregate on the capacity and efficiency of chromatography process

ACS Fall 2021

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