Fast and efficient process development and scale-up contributes to a shortened time to market. In this work, a multidimensional scale-up (change of both column diameter and bed height) of a mAb capture step, using the ÄKTA pilot 600 chromatography system, is demonstrated. Column volume per hour (CV/h) was utilized to enable maintaining residence time throughout the scaling process. The process, performed with MabSelect™ PrismA Protein A chromatography resin, was scaled up 20-fold from a 70 mL HiScale™ 26 column to a 1400 mL AxiChrom™ 100 column. Equivalent mAb recovery and purity was achieved between the larger and the smaller scales, showing a robust and scalable process.
December 14, 2017