USP-compliant analysis of antibody drugs using size-exclusion chromatography

Proteins aggregate due to variances in temperature, pH, and concentration during manufacturing process and storage. Since aggregation of protein products such as monoclonal antibodies (mAbs) may affect safety and efficacy, the degree of aggregation of the products is confirmed by dedicated analytical procedures. Explore how Nexera™ lite inert, high-performance liquid chromatograph (HPLC) was used to perform USP-complied size exclusion chromatography (SEC) analysis of monoclonal IgG antibodies. It was able to provide good repeatability of analyses even employing mobile phase containing high concentrations of salt.