Journal
ANTIBODIES
Volume 8, Issue 4, Pages -Publisher
MDPI
DOI: 10.3390/antib8040056
Keywords
inter-subject variability; pharmacokinetics; monoclonal antibodies; disease; co-administered drugs
Categories
Funding
- Center for Protein Therapeutics
- National Institute of Health/National Cancer Institute [NIH/NCI CA204192]
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Monoclonal antibodies (mAbs) are currently the largest and most dominant class of therapeutic proteins. Inter-individual variability has been observed for several mAbs; however, an understanding of the underlying mechanisms and factors contributing to inter-subject differences in mAb disposition is still lacking. In this review, we analyze the mechanisms of antibody disposition and the putative mechanistic determinants of inter-individual variability. Results from in vitro, preclinical, and clinical studies were reviewed evaluate the role of the neonatal Fc receptor and Fc gamma receptors (expression and polymorphism), target properties (expression, shedding, turnover, internalization, heterogeneity, polymorphism), and the influence of anti-drug antibodies. Particular attention is given to the influence of co-administered drugs and disease, and to the physiological relevance of covariates identified by population pharmacokinetic modeling, as determinants of variability in mAb pharmacokinetics.
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