Generating Aggregation Rates to Determine Stability of Monoclonal Antibodies
Static light scattering is widely used to measure the molar masses of molecules, particles and their aggregates under various solution conditions and compositions. The ARGEN instrument has the capability to run 16 independent light scattering experiments simultaneously. It can monitor the change in both absolute Molecular Weight and Normalized Molecular Weight throughout aggregation or degradation processes. While this note exemplifies the use of ARGEN to characterize monoclonal antibodies, these methods and practices for monitoring and analysis are easily translatable to nearly all soluble synthetic and natural products. This technical note serves as a guide to conducting analysis using the ARGEN software to determine the Aggregation Rate of multiple samples as stressed under various thermal conditions. It is advantageous to make Arrhenius representations of Aggregation Rate for direct and vivid comparisons of stability for different formulations and under different stressors such as temperature and stirring. The Arrhenius Plot also yields Activation Energy over one or more thermal regimes.