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Achieving high load and high throughput with CaptureSMB column format
CaptureSMB is a twin column periodic countercurrent (PCC) process for continuous affinity purification of therapeutic proteins such as monoclonal antibodies (mAbs). CaptureSMB has been implemented at lab and GMP production scale with significant benefits over single-column batch chromatography.
The main benefits include automated and continuous capture of mAbs, typically 40-60% reduction in affinity resin costs and in buffer requirement, a 2- to 3- fold increase in productivity compared to batch chromatography and reduction in equipment footprint.
This article describes the development of lab-scale mAb capture purification step employing the CaptureSMB process using columns of only 5cm bed height. Due to the CaptureSMB process principle, high load and high throughput could be achieved simultaneously with this column format, exceeding 70 G/L/H.
Increasing productivity (throughput) and column load at the affinity capture step is the main driver for implementing continuous processing. Both aims can be achieved using CaptureSMB. In batch chromatography, an affinity column is loaded up to the point of breakthrough of the product and then loading is stopped to prevent product loss. Usually, a safety margin is applied. As the shape of the breakthrough curve is sigmoidal, a significant portion of the expensive affinity resin is not utilized. With CaptureSMB, a second identical column is connected to the outlet of the first column, allowing it to continue loading beyond breakthrough of mAb from the first column, thereby almost fully saturating the first column. This overloading principle is explained in figure 1 (figure available in full article
) that schematically shows a breakthrough curve and the degree of loading that can be achieved with single column capture chromatography and with CaptureSMB. Due to the loading beyond breakthrough that can be carried out at low residence time, resin utilization is maximized, and productivity greatly increases compared to a single column batch method...
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Reducing the Costs of Biopharmaceutical Separations and Purifications with Novel Resins in partnership with BioPharm International. Alongside Purolite, YMC America, Process Technologies Group have contributed in sharing their expertise, research and insights in relation to biopharmaceutical separations & purification with novel resins.