Immunocapture LC–MS Methods for Pharmacokinetics of Large Molecule Drugs

Implementation of immunocapture LC–MS methods to characterize the pharmacokinetic profile of large molecule drugs has become a widely used technique over the past decade. As the pharmaceutical industry strives for speediness into clinical development without jeopardizing quality, robust assays with generic application across the pipeline are becoming instrumental in bioanalysis, especially in early-stage development. This review highlights the capabilities and challenges involved in hybrid immunocapture LC–MS techniques and its continued applications in nonclinical and clinical pharmacokinetic assay design. This includes a comparison of LC–MS-based approaches to conventional ligand-binding assays and the driving demands in large molecule drug portfolios including growing sensitivity requirements and the unique challenges of new modalities requiring innovation in the bioanalytical laboratory.