Novel Purification Technologies and Approaches to Maximize Speed, Efficiency and Process Optimization
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 an affinity chromatography that possesses 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.