Quality control during the manufacturing process of therapeutic glycoproteins requires suitable analytical methods to monitor consistency and stability of the critical quality attributes such as the glycome. HighPerformance Anion Exchange Chromatography (HPAEC) coupled to Pulsed Amperometric Detection (PAD) is a highly sensitive and selective technique for the analysis of intact glycans as well as the monosaccharides building blocks. Even minor variations in the carbohydrate structures can be detected quickly making the method an essential tool during early drug development, process monitoring and validation as well as batch release testing during routine analysis.

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