282733 Optimization of High Throughput Process Development Methodologies for Chromatographic Process Development

Wednesday, October 31, 2012
Hall B (Convention Center )
Jessica Lewis, Downstream Process Development, Biopharmaceutical Process Development, GlaxoSmithKline, King of Prussia, PA

The desire to be ‘first to market’ combined with the need to reduce production costs drives the need for novel and improved high throughput methods that yield rapid and predictive process development. To this end, much effort in recent years and across the industry has been placed into adapting robotic liquid handling and high throughput methods to streamline chromatographic process development. Here, we demonstrate an optimized protocol using  miniaturized “resin plates” (96-well plates containing defined volumes of chromatography media) that reduces error and helps to better characterize adsorption isotherms and binding trends as a function of solution conditions (binding maps). We focus primarily on static binding experiments over dynamic experiments because the latter can be measured directly on ÄKTA FPLC systems using mini-columns if automation approaches are fully exploited. We propose standard methodologies with respect to high throughput chromatographic process development on robot liquid handlers for both monoclonal antibodies and domain antibody fragment process development. By using high throughput techniques in this focused manner, we have been able to increase overall process understanding, reduce the duration of downstream development time, and minimize the amount of manual labor required for understanding the binding behavior of proteins of interest.

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