A cell-based FcRn-dependent recycling assay for predictive pharmacokinetic assessment of therapeutic antibodies

C Liu , Y Kim, J Lowe & S Chung | Bioanalysis, 13(14), 1135-1144 (2021) Keywords: • biotherapeutics • cell-based assay • FcRn • pharmacokinetics • recycling Aim: Evaluation of suitable pharmacokinetic properties is critical for successful development of IgG-based biotherapeutics. The prolonged half-lives of IgGs depend on the intracellular trafficking function of neonatal Fc receptor, which rescues internalized IgGs from lysosomal degradation and recycles them back to circulation. Results: Here, we developed a novel cell-based assay to quantify recycling of monoclonal antibodies in a transwell culture system that uses a cell line that stably expresses human neonatal Fc receptor....