Sialic Acid Analysis
Sialic acid analysis is used in the analysis of glycoproteins and carbohydrates to determine the identities and quantities of the sialic acid species present. This information can be used at all stages of drug development. It can also be used to demonstrate consistency between batches for release during the manufacturing process.
Sialic acid analysis is a powerful technique in glycoprotein analysis. It can be used for:
An initial investigation prior to more detailed analysis of the glycosylation of the product.
Screening of glycoproteins manufactured using different cell lines.
Sialic acid analysis is performed using High Performance Anion Exchange Chromatography with Pulsed Amperometric Detection (HPAEC-PAD). This technique allows the separation and quantitation of, for example, N-Acetylneuraminic acid and N-Glycolylneuraminic acid.
Sialic acid analysis is a key part of the requirement laid out in the ICH Q6B guidelines for characterisation and confirmation of biopharmaceuticals in support of new marketing applications.