Andrew Coffey

Protein aggregation, where molecules assemble into dimers, trimers, tetramers or larger multimers, is a common occurrence that can have devastating consequences. Biotherapeutic proteins such as monoclonal antibodies can give rise to severe immunological events as a result of aggregation. Therefore, quantification and monitoring using size exclusion chromatography (SEC) are paramount during manufacture and lot-release QC. This application note considers some of the factors that can influence the degree of aggregation and the importance of optimizing methodology.