Quantitative analysis of monoclonal antibodies by cation-exchange chromatofocusing |
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Authors: | Anna Rozhkova |
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Affiliation: | Solvias AG, Analytics Klybeck, Klybeck Street 191, 4002 Basle, Switzerland |
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Abstract: | A robust cation-exchange chromatofocusing method was developed for the routine analysis of a recombinant humanized monoclonal IgG antibody. We compare the chromatofocusing method to the conventional cation-exchange chromatography (CEX) employing a salt gradient and show clear advantages of chromatofocusing over CEX. We demonstrate the suitability of the present chromatofocusing method for its intended purpose by testing the validation characteristics. To our knowledge, this is the first chromatofocusing method developed for the routine analysis of monoclonal antibody charge species. |
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Keywords: | Monoclonal antibody Cation-exchange chromatofocusing pH gradient Acidic species quantitation Isoform content determination Lot release analysis |
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