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Timothy Iskra, Glen R. Bolton, Jonathan L. Coffman and Ranga Godavarti The effect of protein a cycle number on the performance and lifetime of an anion exchange polishing step Biotechnology and Bioengineering 110

Version of Record online: 10 DEC 2012 | DOI: 10.1002/bit.24781

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An understanding of the performance linkages between the unit operations can lead to robust manufacturing processes. In this study, a unique linkage between two chromatography unit operations is described. When material from a Protein A column that had been cycled a few times (<10) was loaded on the anion-exchange chromatography resin, premature loss of capacity was observed. Depth filtration of the Protein A peak pool was found to reduce the level of the foulant and significantly improve the AEX resin capacity, robustness and lifetime.

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