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Coupled Affinity and Sizing Chromatography: A novel in-process analytical tool to measure titer and trend Fc-protein aggregation.

Lemmerer, Martin and London, Anne and Pannicucci, Alexandra and Gutierrez-Vargas, Cristina and Lihon, Michael (2013) Coupled Affinity and Sizing Chromatography: A novel in-process analytical tool to measure titer and trend Fc-protein aggregation. Journal of Immunological Methods, 393 (1/2). pp. 81-85. ISSN 0022-1759

Abstract

The expanding use of monoclonal antibodies in the biopharmaceuticals industry has brought the need for new analytical tools. We have developed a coupled affinity and gel-filtration high-performance liquid chromatography method to simultaneously analyze titer and quality of monoclonal antibodies. Before this assay, available analytical methods for protein aggregation required highly purified proteins. This assay can qualitatively describe a protein from a clarified cell culture solution by trending protein aggregation over time while measuring protein titer. It can be used to assess proteins in both early and late stage culture due to its dynamic range and sensitivity. This assay is a sensitive technique that overcomes the time limitations of previous approaches. It provides an essential tool to accomplish process optimization.

Item Type: Article
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Keywords: chromatography
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Date Deposited: 13 Oct 2015 13:14
Last Modified: 13 Oct 2015 13:14
URI: https://oak.novartis.com/id/eprint/8953

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