Abstracto

The impact of continuous multicolumn chromatography on biomanufacturing efficiency

Marc Bisschops* and Mark Brower

Over the past few years, the capacity bottleneck in biomanufacturing has shifted from the upstream process to the purification process. In particular, capture chromatography steps have become a limiting factor in facility throughput. This is a direct result of the discrepancy between expression levels, which have increased by a factor of ten, and the capacity of biochromatography media, which has at best doubled. Continuous countercurrent multicolumn chromatography is a promising approach to deal with the capacity bottleneck, particularly if designed in a single-use format. BioSMB™ technology is a disposable bioprocess technology that allows standard capture chromatography steps, such as Protein A capture, to be executed with much less installed chromatographic media using a multicolumn chromatography process. This allows an economically favorable, single-use option where none has previously been available. Various case studies have demonstrated the advantages of this technology for various separations. In this paper, we provide theoretical background on designing continuous multicolumn chromatography processes. With these models, the advantages of continuous processing will be illustrated.