High throughput process development has become a standard practice in the biopharmaceutical industry. This highly efficient format can reduce material consumption, time, and other resources, enabling process understanding and optimization early on during a protein therapeutics development. In this presentation, we will show three case studies using high throughput methods to facilitate antibody purification process development and characterization. 96-well filter plates with small volumes of resin were used to define a design space for optimal performance and garner a better understanding of the impact of operating parameters in a multimodal flow-through step. Similarly, filter plates were used to screen multiple wash conditions for optimized impurity clearance in a Protein A step. Lastly, the combined technologies of a robotic liquid handler and miniaturized pre-packed columns were used to characterize a cation exchange chromatography process. In all three cases, the results of the high throughput studies were compared to typical bench scale chromatography results, and the findings will be illustrated and discussed.

Enabling high-throughput downstream process development: From method screening to process characterization

251st National Meeting (2016)

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