Bioanalytical strategy for the characterization and bioanalysis of biologics: a global, nonregulated bioanalytical lab perspective

Sarvaiya H, Niu S, Ladror D T, et al. | Bioanalysis, 15(3), 133-148, (2023) Keywords: • antibody–drug conjugates • bioanalysis • biologics • biotransformation • cellular disposition • characterization • hybrid LC–MS • ligand-binding assay • pharmacokinetic • post-translational modifications • stability Over the past two decades, we have seen an increase in the complexity and diversity of biotherapeutic modalities pursued by biopharmaceutical companies. These biologics are multifaceted and susceptible to post-translational modifications and in vivo biotransformation that could impose challenges for bioanalysis. It is vital to characterize the functionality, stability and biotransformation products of these molecules to enable screening,...