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The role of more than 40 years of improvement in protein A chromatography in the growth of the therapeutic antibody industry.

Biotechnol Prog.. 2016-09; 
GR Bolton, KK Mehta.
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摘要

Protein A chromatography has been used as the mAb capture step in the majority of FDA submissions. In this study, the performance of protein A chromatography, as indicated by capacity, operational flow rate, and productivity (rate of mAb production per liter of resin) was examined over its full history to gain insights into the reasons for its consistent use. Protein A productivity and capacity have increased 4.3 and 5.5% a year, respectively, since 1978. In contrast, protein A operational flow rate increased between 1978 and 2001 and then remained constant or declined as further improvements provided only marginal benefits. The productivity of protein A resin and also the mAb bioreactor titer (14% growth) rapi... More

关键词

SpA; affinity chromatography; mAb; monoclonal antibody; protein A; purification
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