An optimized downstream process is needed to efficiently manufacture and support the more than one thousand antibody therapeutics currently in clinical development. Although technological advancements such as chromatography resins with higher binding capacities, in-line process monitoring, and digitization has improved antibody manufacturing, downstream processing is still a major bottleneck. Herein, we will present an optimized downstream purification process that utilizes a novel approach to connect unit operations such as affinity chromatography resin, viral inactivation and cation exchange polishing steps.
Additionally, we demonstrate the use of novel buffers and additives for column washing and generation to increase impurity clearance in a single step to meet quality requirements while simultaneously reducing overall process time. We have screened various buffer additives and identified few for use in affinity chromatography step that can remove at least 50% more host cell protein impurities and antibody aggregates in a single step as compared to traditional approaches. In totality, these additives utilized in conjunction with optimized purification process represents a highly efficient and advantageous approach to obtaining purified monoclonal antibodies.ter experts on the topic of optimizing downstream processes.
Jungmin Oh, Manager - New Product Development, Avantor
