Engin Ayturk, PhD Senior Manager at Biogen

Protein A chromatography, an affinity-based purification method that selectively binds antibodies, is generally considered as one of the most expensive steps in a downstream process due to the high cost of protein A resin.  Decreasing the effective cost of the protein A step can be accomplished by increasing the amount of antibody that is processed per column cycle, either by increasing resin capacity or enhancing resin utilization through processing strategies such as continuous chromatography. Additionally, increasing the number of times a column is cycled can drive down the protein A cost per batch.

Here, we discuss the evaluation of a next generation protein A resin (MabSelect PrismA) with increased capacity and base-stability relative to other commercially available resins.  Dynamic binding capacity and purification performance at different loads were determined for several monoclonal antibodies on both a current generation protein A resin (MabSelect SuRe LX) and MabSelect PrismA. The impact of increased column loading on elution peak width and eluate pool pH were further investigated.  Cycling studies with representative cell culture material were also planned to assess whether increased resin lifetime could be achieved with MabSelect PrismA by utilizing a more stringent cleaning approach. Finally, an evaluation of continuous processing productivity was performed to maximize productivity and yield, while maintaining comparable product quality to batch purification. The results from the aforementioned studies provide evidence for a benefit of implementing MabSelect PrismA, through cost and productivity analyses for different processing scenarios