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Rapid process development for purification of a MAb using ÄKTA™ avant 25

 (28957347AB.pdf - 1349 Kb)


ÄKTA avant 25 system controlled by UNICORN™ 6 software was used to develop a two-step chromatography process for purification of a monoclonal antibody (MAb). MabSelect SuRe™, a protein A-based chromatography medium (resin) was used for the initial capture step while the multimodal anion exchanger Capto™ adhere was used for reduction of impurities in a second, polishing step. An experimental design was applied to the polishing step to screen loading conditions. Sample pH, conductivity, and load were varied. Using 1 ml prepacked HiTrap™ columns, the design was run in less than 24 h and a reduced design was performed to establish the robustness of the process conditions. Using the Design of Experiments (DoE) functionality incorporated in UNICORN 6 together with HiScreen™ prepacked columns, optimization of the overall process was achieved in approximately one week. Despite the challenging nature of the feed studied, high yield and purity of the target MAb was achieved.





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