The aggregation of biopharmaceuticals is a complex physical process. Its analysis requires the use of a selection of suitable methods to build up a comprehensive dataset that can then support appropriate interpretation and scientifically sound conclusions.
The orthogonal methods discussed in this white paper (SV-AUC, SEC, SEC-MALS, DLS, SDS-Page and FFF) provide ways of characterizing soluble aggregates but have a number of limitations in their abilities to provide quantitative information. Proper method selection ensures data is both orthogonal and valuable, and that none of the data collected is redundant.
