Development of an intermediate chromatography step in an insulin purification process. The use of a High Throughput Process Development approach based on selectivity parameters

Subsequent optimization was performed in small packed columns using a Design of Experiments (DoE) approach with statistical modeling before scaling up to a small pilot scale experiment. In this study insulin was effectively purified from the more tightly-binding C-peptide, and a reduction in insulin variants was also noted using the optimized conditions.