Twin-column CaptureSMB: a novel cyclic process for protein A affinity chromatography

Area of Science:

• Biopharmaceutical Manufacturing
• Chromatographic Separation Science
• Protein Purification

Background:

• Protein A affinity chromatography is crucial for monoclonal antibody (mAb) purification.
• Traditional batch chromatography often underutilizes the stationary phase capacity.
• Optimizing resin utilization is key to reducing manufacturing costs.

Purpose of the Study:

• To evaluate the performance and product quality of CaptureSMB compared to batch chromatography for mAb capture.
• To assess the impact of key process parameters (flow rate, column length, titer) on CaptureSMB.
• To determine the economic benefits of implementing CaptureSMB.

Main Methods:

• Utilized a twin-column counter-current chromatography system (CaptureSMB) for protein A affinity capture.
• Performed a mAb capture case study comparing CaptureSMB with conventional batch chromatography.
• Investigated the effects of varying flow rate, column length, and initial mAb concentration (titer).

Main Results:

• CaptureSMB demonstrated significantly higher productivity and capacity utilization than batch processes.
• Improved product concentration and reduced buffer consumption were observed with CaptureSMB.
• Economic analysis indicated potential resin cost reductions of 10-30%.

Conclusions:

• CaptureSMB offers a superior alternative to batch chromatography for mAb protein A capture.
• The process enhances efficiency, reduces waste, and provides substantial economic advantages.
• CaptureSMB is a scalable and cost-effective solution for biopharmaceutical purification.