The problems that arise in downstream processing of therapeutic proteins from complex mixtures are, above all, losses caused by the purification procedures, resulting in lower yield. The introduction of modern filtration and chromatographic techniques, especially the sterile filtration, ion-exchange chromatography and affinity chromatography allows the production of highly purified concentrates of therapeutic proteins and also of single plasma proteins. However, the chromatographic techniques in particular still suffer from serious flaws, especially in terms of speed and capacity. Therefore, the risk of unwelcome changes or loss of activity in the sensitive biopolymers can not be ruled out and is only prevented by careful investigation of the production process.
This work will present the application of CIM Convective Interaction Media®, novel polymeric monolithic columns, for in-process analyses and fast analytical and preparative separations of pharmaceutically relevant biopolymers. The questions like the optimisation of the chromatographic parameters for an efficient separation and the effect of the operational parameters on the binding capacity and yield will be addressed. Finally, real applications using ion-exchange purification of a clotting factor IX (FIX) will be discussed.