Antibody capture with twin-column continuous chromatography: Effects of residence time, protein concentration and resin

摘要

The rapid development of the biopharmaceutical industry has gradually shifted the focus of R&D to integrated continuous manufacturing. In this study, the effects of residence time and protein concentration on the performance of twin-column periodic counter-current chromatography for continuous antibody capture with new affinity resin Praesto Jetted A50 were evaluated. The results showed that the continuous process exhibited better performance with higher productivity, higher capacity utilization and lower buffer consumption when compared with the batch process. Meanwhile, the increase of protein concentration could increase productivity, while it showed minor impact on capacity utilization and buffer consumption. Furthermore, monoclonal antibody (mAb) continuous capture from clarified cell culture supernatant was investigated. The results showed that the qualities of the products obtained from the continuous and batch processes were similar. The performance of the continuous capture process at 1 min residence time was significantly better than the batch process with the improvements in productivity (37.5 g/L/h) and capacity utilization (77.8%) as well as reducing buffer consumption by 60%. Finally, effects of Protein A resins on the continuous process were discussed, and the results indicated that the Protein A resins with higher dynamic binding capacity at low residence time would be more suitable for continuous processes. In general, continuous capture under the suitable operation conditions shows good performance and has great potential for mAb production.