High throughput screening has become a powerful tool for purification process development. Plate based screens can identify target operating conditions but require lab scale runs for confirmation and testing at target load challenges. RoboColumns offer the ability to test small chromatography columns at conditions more similar to lab scale and manufacturing scale operations. Development efforts can be expedited when 8 RoboColumns are run in parallel and each run generally uses at least 10-fold less material. As many as 16-24 RoboColumn experiments can often be run in a single day compared to 2-3 using lab scale columns.<br/><br/>We have integrated RoboColumns into early and late stage antibody process development. As opposed to the traditional paradigm of moving from HTS to lab scale to pilot scale, we leverage RoboColumn experiments in parallel with lab and pilot runs to build process understanding. RoboColumns have been used to test high load challenge flow through steps, optimize wash and elution buffers for bind and elute steps, and further purify lab scale samples to determine the impact of upstream development on final pool purity. In these cases we increased the number of experiments we were able to perform with limited material and time resources. RoboColumn utilization has consistently provided increased process knowledge and robustness at all stages of process development.

Increasing process knowledge using high throughput RoboColumns

255th National Meeting (2018)

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