Resin Replacement Study Using JSR Amsphere™ A3 And A Platform Resin To Reduce The Supply Risk Of Protein A Resin

Biopharmaceutical companies have long been concerned with preserving security of supply of both products and consumables, including chromatography resins. Amsphere A3 resin is currently involved in over 95 clinical phase trials. Independent studies have confirmed its productivity and competitiveness. Given the wide range of targets (such as mAb/Fc-fusion/Fab) and processing conditions for which it performs well, Amsphere A3 can be considered a “universal” affinity resin for the processing of antibody-based biopharmaceuticals. 

In this study, it was found that Amsphere A3 offered equivalent performance to SuRe LX throughout the process, including the protein A capture step and the follow on Anion exchange (AEX) and Cation exchange (CEX) polishing operations. In addition, detailed host cell protein (HCP) analysis of target elution pools by mass spectrometry further reinforced the similarity of performance offered by the two affinity resins.

These findings highlight how supply chain resiliency may be improved since purification performance of Amsphere A3 compared to other products can enable alternate and dual sourcing.