Application of multiplexed pharmacokinetic immunoassay to quantify drug forms and coadministered biologics.

Meso Scale Discovery U-PLEX provides an opportunity to develop multiplexed pharmacokinetic (PK) immunoassays. Two case studies demonstrate the utility of multiplexed PK methods. Development of PK ligand-binding assays quantify of nonclinical plasma concentrations of a biotherapeutic that has degraded due to biotransformation, and clinical serum concentrations from two biotherapeutics spiked into a single sample. Data from multiplexed U-PLEX PK methods are comparable to results from single-readout streptavidin Meso Scale Discovery gold PK methods. Multiplex measurement of a nonclinical study showed acceptable performance for accuracy, precision and dilutional linearity while a clinical study additionally passed selectivity, specificity and stability. Regulated, validation-ready multiplex PK methods for both nonclinical and clinical studies allow opportunities for high-throughput bioanalysis.