A reactive continuous chromatographic process for protein PEGylation

Abstract

In a previous work, a batch on-column PEGylation process was developed and thoroughly investigated (Pfister et al., Reaction Chemistry & Engineering, 2016). A mathematical model was derived and its predictions compared with experimental data were obtained under various conditions. As an alternative, a multicolumn counter-current chromatographic setup is considered to turn the batch on-column PEGylation process into a continuous one. Using the parameters previously estimated, the continuous chromatographic process in the form of a reactive multicolumn counter-current solvent gradient purification (rMCSGP) process was simulated and the performance of the process was assessed. Batch experiments were performed to show the feasibility of the method and to determine the parameters specific to the design of multicolumn processes. It is shown that the rMCSGP process can improve the throughput, purity and yield for the production of mono-PEGylated protein.