Evaluation of ProSep Ultra PlusŪ Protein A affinity media for mAb downstream process

BIOT 50

Vincent Chai, vchai@amgen.com, Amgen Inc, Thousand Oaks, CA 91361, Tony Hong, thong@amgen.com, Process Development, Amgen Inc, Mail Stop 30W-2-A, One Amgen Center Drive, Thousand Oaks, CA 91320, and Joe Zhou, Purification Process Development, Amgen Inc, One Amgen Center Drive, MS 30W-2-A, Thousand Oaks, CA 91320.
Protein-A affinity chromatography is commonly used as an efficient capture and purification step in monoclonal antibody downstream processes. With its high specificity, this unit operation can routinely remove greater than 99% of non-product impurities. However, with rapidly increasing cell culture titers, Protein A chromatography may soon become the bottleneck and the step productivity of Protein-A resin forms a great challenge to increase process efficiency. Therefore, a full evaluation of a newly designed resin matrix is important to the mAb industry.

In this presentation, ProSep Ultra PlusŪ Protein A affinity resin from Millipore was fully evaluated for product throughput in comparison with agarose based resin. The high binding capacity with variable residence time, together with the effects of bed height on the packing profile and different wash solutions for the effective removal of process impurities are discussed.