Bioseparation using membrane chromatography: Innovations, and challenges.

The resin-based column continues to be the dominant incumbent in bioprocess chromatography. While alternative formats such as membrane-, monolith- and fiber-based chromatography are more visible than before, each still plays minor roles. The reasons for this are complex and some of these are explained in this paper. However, the fact remains that membrane chromatography has come a long way since its early days of development. The main advantage of membrane chromatography continues to be its convection dominant transport mechanism, the resultant benefit being fast and scalable separation. Also, resolution obtained with properly designed devices could be comparable or even better than resin-based chromatography. Significant progress has been made in new membrane development, membrane characterization, device design and novel applications development. A wider range of new membrane matrices, ligands, and ligand-matrix linking chemistries are now available. New membrane modules, formats, and process configurations have also helped improve membrane performance. However, some significant challenges still exist, and these need to be addressed if membrane chromatography is to become more mainstream in the field of bioprocessing. Also, membrane chromatography has significant potential for application in analytical separations and this space has hardly been explored. In this paper, the advances in the areas of membrane preparation, device design and process development are reviewed. A high-level cost analysis is presented and the role of process design in membrane chromatography is discussed.