Evaluation of several protein a resins for application to multicolumn chromatography for the rapid purification of fed-batch bioreactors.

Most of the existing production capacity is based on fed-batch bioreactors. Thanks to the development of more efficient cell lines and the development of high-performance culture media, cell productivity dramatically increased. In a manufacturing perspective, it is necessary to clear as quickly as possible the protein A capture step to respect the manufacturing agenda.

Large-scale monoclonal antibody purification by continuous chromatography, from process design to scale-up.

The development and optimization of a purification process of monoclonal antibodies based on two continuous chromatography steps for capture and intermediate purification are presented. The two chromatography steps were individually optimized using either batch chromatography or sequential multicolumn chromatography (SMCC). Proprietary simulation software was used to optimize SMCC and to evaluate the potential gains compared with batch chromatography.