(204f) Prediction and Optimization of Chromatographic Performance Using High Throughput 96-Well Plates

Traditional purification process development involves screening of adsorbents and operating conditions using packed chromatography columns. The increasing need for rapid, low cost process development for biopharmaceutical proteins would benefit from the implementation of high throughput development methodologies. Furthermore, the potential for using high throughput techniques to screen a wide variety of conditions early in development could better provide an early glimpse into the manufacturing design space. The studies described here, for example, explore the utilization of chromatography resin in a 96 well plate format to accelerate purification process development. More specifically, the 96 well plate methodologies are used to rapidly screen factors that significantly impact chromatographic performance. These data, in turn, can be used to predict the performance of packed chromatography columns. The application of the rapid screening techniques will be described for the separation of monomer and aggregate species on anion exchange chromatography. The resulting predictions will be compared with experimental results obtained with packed chromatography columns.