In the high-stakes realm of biopharmaceutical research and development, understanding antibody stability is very important. Antibody stability is a multi-faceted concern that includes aspects of aggregation, degradation, and conformational integrity. Each of these potential problems can negatively impact antibody stability and the performance and manufacturability of biotherapeutics.Read More
Recent research on stress factors in monoclonal antibody development underscores the critical need for robust control strategies in monoclonal antibody drug substance production, focusing on the risks posed by various stress conditions during manufacturing. These stressors can lead to protein modifications, impacting both patient safety and product quality. ARGEN, by Yokogawa Fluence Analytics, is a...Read More
Colloidal stability is determined by the balance of repulsive and attractive intermolecular interactions between protein molecules, like a monoclonal antibody, to conserve the native folded state. Simply stated, the propensity for aggregation is reduced by less intermolecular interaction. Therefore, determination of the second virial coefficient (B22) is a valuable screening tool to predict aggregation propensity....Read More
In these experiments, ARGEN was used to characterize the thermal and chemical stability of a monoclonal antibody and subsequently establish quantitative and qualitative properties such as pH and temperature dependence on aggregation kinetics. Additionally, SEC elution profiles were superimposed onto Mw/Mo output, providing a robust comparison and identification of the stability landscape for the mAb....Read More
