Aggregation of peptides, proteins, and antibodies is a common phenomenon that may occur for various reasons, such as pH, temperature, freeze-thawing, shear, among others. In pharmaceutical industry it is strongly recommended to have control of aggregation already at early stage of the development process of the drug product. During later stages regulatory agencies require such tests to be performed. Aggregation also has a significant effect on the properties of product in areas other than the pharmaceutical.
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 thorough the use of an orthogonal technique 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.