Efficient method development of monoclonal antibody size variants by SEC

ICH Guideline Q6B requires the separation of impurities such as aggregates and fragments in antibody drugs and determines their content. Therefore, monitoring these impurities by size-exclusion chromatography (SEC) is one of the most important analyses during the production of monoclonal antibodies (mAbs).

Explore this example of efficient method optimization for providing enough separation and robustness for mAb size variants by using the corrosion-resistant Nexera™ XS inert system, pH monitor (pHM-40) and Shimadzu's LabSolutions™ MD software. The method achieves reliable separation while minimizing system damage from high-salt mobile phases.