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Method Development for Ion Exchange Using Dynamic Buffer Generation

On-demand webcast: Aired November 16, 2017
Register for free at www.chromacademy.com/Method-Development-for-Ion-Exchange-Using-Dynamic-Buffer-Generation.html

KEY LEARNING OBJECTIVES

Charge Variants are a type of Critical Quality Attribute that are present in biotherapeutic proteins needing to be analyzed and quantified. Unlike small molecule synthetic compounds, large proteins produced using recombinant manufacturing techniques typically contain numerous minor heterogeneities. These can arise during manufacture, including through post-translational modifications, or through other means such as chemical degradation. A monoclonal antibody contains over 1,300 individual amino acids and may contain more than 100 acidic amino acids (aspartic and glutamic acid) and perhaps more than 150 basic amino acids (arginine, histidine and lysine). Some of the modifications that can occur, such as deamidation of asparagine or loss of C-terminal lysine, can lead to additional acidic side chains and a change in net charge. Cation exchange chromatography is a suitable technique for separating these charge variants, however optimizing the separation and demonstrating method robustness is a very time consuming chore. This webcast will teach you how systematic screening of multiple experimental conditions can be performed very efficiently for greatly improved productivity. 

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