Aggregation of peptides, proteins and antibodies is a common phenomenon that may occur for various reasons, such as pH, temperature, freeze-thawing, shear or other factors. During development of pharmaceutical products it is strongly recommended to have control of the aggregation already in the early stages. During later stages regulatory agencies require such tests to be performed. Also in areas other than the pharmaceutical industry aggregation may have a significant effect on the properties of a product.
Screening of solutions to detect aggregation is often performed by DLS during early stages, while later SEC is a common methodology to obtain more quantitative data. During later stages regulatory agencies often require SEC analysis to be validated through the use of orthogonal techniques such as AF4-MALS and AUC. At SOLVE we have a long history of analyzing and characterizing aggregation both during early and later stages of product development. We can supply the full range of commonly required analytical techniques, such as SEC-MALS, AF4-MALS, and AUC, to supply aggregation data that is accurate and orthogonal during the entire project.