Use of multi-column capture chromatography has been demonstrated to offer significant advantages over traditional batch chromatography in regards to improvement in productivity and capacity utilization of the resin. However, it is not clear how many columns makes the format most effective and the pros and cons with each approach. In this study, we compared single column batch chromatography against continuous chromatography using 2-Column, 3-Column and 6-Column formats. Specifically, we studied the effects of feed titer, feed flow rates, CIP hold times and product break through on the productivity and capacity utilization in each of these formats. In addition, effects of column format on product quality i.e. HCP clearance, DNA clearance and residual protein-a clearance will be discussed as well. At feed titers in the range of 2 - 20 g/L, our results show that all formats of multi-column chromatography offers significant improvement in both productivity as well as capacity utilization over batch chromatography. At titters beyond 20 g/L the advantage starts to diminish with respect to productivity but the difference in capacity utilization remains. Between the multi column formats, 6-column format offered noticeable improvement in productivity over others but capacity utilization was significantly higher in 2-column format. Results demonstrate that depending on the needs for short clinical campaigns versus longer commercial campaigns, one can choose the appropriate format the fits the need. Further, effects of media format (i.e. resin vs. membrane, bead size & ligand density) will be discussed as well along with integration of automated low pH viral inactivation post capture.

Optimization of multi-column format for continuous capture of monoclonal antibodies

253rd National Meeting (2017)

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