Therapeutic monoclonal antibodies (mAbs) remain an important segment of the biopharmaceutical industry, delivering highly effective and targeted responses against human diseases. The immune complexes formed between a therapeutic mAb and its target antigens may affect efficacy, clearance (pharmacokinetics), and immunogenicity. As such, immune complexes represent an important biophysical property to characterize during drug product screening and development. In this study, we leverage asymmetric flow field‐flow fractionation coupled with multiangle light scattering (A4F‐MALS) to evaluate the size distribution of complexes formed between a panel of therapeutic mAbs directed against a common target antigen. The inclusion of this analysis enables important insights that can guide the screening of therapeutic candidates during lead candidate assessments, as well as risk mitigation to help better inform clinical design strategy.
Liu et al. (Thu,) studied this question.