Developing A Closed Connected Single Use mAb Purification Process

Pharmaceutical manufacturers are striving for more diversified portfolios targeting a greater number of monoclonal antibodies (mAb), the key to driving down overall costs is to lower capital expenditure (CAPEX) investments by better utilization of equipment. This drives the need for flexible solutions that can reduce facility footprint and minimize changeover time between campaigns.

Strategies to address these demands include the use of variable degrees of continuous processes, which enables the use of smaller chromatography columns and bioreactors. This, in turn, allows for reduced buffer consumption and overall facility footprint. Complementary approaches also include designing closed and connected process steps using single-use equipment and consumables to enhance flexibility and minimize the need for expensive clean rooms and storage space.

The purpose of the described study was to develop a closed and physically connected downstream purification process for material from a perfusion cell culture. The equipment and consumables were primarily single-use and designed for a manufacturing process in a good manufacturing practices (GMP) environment. To compare the performance of resin based chromatography to fiber-based chromatography methods, the purification process was divided into two separate processing trains. One process used a prepacked ReadyToProcess MabSelect PrismA column for the capture step. The second process used a pilot-scale Fibro PrismA, a fiber-based technology that enables single-use, rapid cycling chromatography. The Fibro PrismA unit used in this study was a prototype 160 mL unit and is not yet commercially available.