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physiologically based modeling to predict monoclonal antibody pharmacokinetics in humans from in vitro physiochemical properties

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Based on in vitro measurements of the physiochemical characteristics of the antibody, a model-based approach is offered to forecast the pharmacokinetics (PK) of monoclonal antibodies (mAbs) in humans.

The predictive power of 14 in vitro assays created to measure different antibody physiochemical properties, such as nonspecific cell-surface interactions, FcRn binding, thermal stability, hydrophobicity, and self-association, is investigated using a physiologically based pharmacokinetic (PBPK) model. We discovered a significant positive correlation (R = 0.64, p =.0013) between the model parameter representing antibody-specific vascular to endothelial clearance and heparin relative retention time, an in vitro measure of nonspecific binding, based on the mean plasma PK time course data of 22 mAbs from humans reported in the literature.

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