Sanofi’s key driver for this study was to reduce the operating costs of existing purification steps with high resin costs. Regulatory concerns were to be tested by determining product quality consistency through process transfer and scale-up. The feasibility of extended purifications at production scale was also determined by evaluating BioSMB system robustness.
The aim of this study was to explore the benefits of multi-column chromatography and application to a perfusion based process. Resin savings and the capability of continuous chromatography to run for long process times were important decision factors in the selection of the technology.
This case study centred on transferring an existing batch chromatography process into a multi column format and then scaling up that process to an continuous perfusion run. The bioreactor was a 50 L single-use perfusion setup where the maintenance of aseptic conditions and flow path robustness were key to meet the target of a 10 day run time that ultimately processed a feedstock volume of approximately 800 L.