Bispecific protein therapeutics present unique challenges for pharmacokinetic (PK) characterization because multiple functional domains must be evaluated, along with potential biotransformation and interference from anti-therapeutic antibodies. This review presents case studies and a regulatory perspective on developing PK assay strategies for bispecific molecules, emphasizing the need to consider each molecule’s structure, mechanism of action, target biology, and PK/PD data requirements. Because assay approaches must be tailored to each construct, a fit-for-purpose strategy is essential for developing reliable, robust, and reproducible measurements that support drug development and help characterize the in vivo structure-function relationship of these complex therapeutics.
Read the article featured in the January 2019 edition of Bioanalysis.
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