The commercial purification process for an FDA approved insect cell-derived Cellular Immunotherapy was re-developed. The goal of the second generation process was to reduce the number of chromatographic steps, improve process robustness and get a 100% improvement in overall yield. High Throughput Process Development (HTPD) with a Tecan automated liquid handling system was used in conjunction with high throughput analytical tools. These techniques were applied to rapidly screen binding conditions, capacities and resolution on various resin modalities in 96-well filter plates. Once the optimal operating windows were determined, the resins and processing conditions were scaled up into RoboColumns, run eight at a time on the Tecan, for optimization of each unit operation. The optimized process was then further scaled up to allow a comparability assessment with the existing product.

High throughput process development of a commercial second generation antigen purification process

243rd National Meeting (2012)

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