Non-Size-Based Membrane Chromatographic Separation and Analysis of Monoclonal Antibody Aggregates

Humanized monoclonal antibody produced by mammalian cell culture may contain significant amounts of antibody dimers and smaller amounts of higher order aggregates. These are undesirable in therapeutic formulations, and their content should be lower than specific allowable limits. Quantitative analysis of aggregate content is usually carried out by size exclusion chromatography (SEC), which is slow and often gives poorly resolved peaks. We …