Characterizing SEC Columns for the Investigation of Higher-Order Monoclonal Antibody Aggregates.

With many new biopharmaceuticals now being developed, robust analytical methods are needed to ensure that these protein-based drugs are of high purity and safe with a minimum amount of side effects. Size-exclusion chromatography (SEC) is an important technique for investigating purity and is useful to identify and monitor protein aggregation, which can have economic and immunogenicity effects. This article discusses those column p; for SEC separations. [ABSTRACT FROM AUTHOR]