High-throughput screening was employed to investigate the performance of an ELP-Z affinity precipitation system. The effects of a range of operating conditions on antibody precipitation, elution, product purity and quality were examined. Conditions providing high levels of recovery with low levels of aggregation were initially identified for the pure antibody. A set of these conditions were further employed to determine performance using harvested cell culture fluid. The clearance of impurities such as HCP, DNA etc. during the process was determined. A set of conditions providing high levels of product recovery and low levels of impurity were identified and selected for scale-up studies. Process scale-up was carried out and the performance at each scale was determined. Finally, various strategies for precipitate recovery such as filtration and centrifugation were examined during scale-up. This work sheds light on the industrial applicability of the process.

Purification of monoclonal antibodies using ELP smart biopolymer based affinity precipitation system: HTS and scale-up studies

245th National Meeting (2013)

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