Exploitation of the size-exclusion effect of reversed-phase high performance liquid chromatography for the direct analysis of diethylene triamine pentaacetic acid in therapeutic monoclonal antibody formulations.

⿢RP-HPLC of ⿿size exclusion effect⿿ for early elution of monoclonal antibodies (mAb).⿢Direct analysis of DTPA without an antibody removal prior to HPLC injections.⿢Application of method to multiple formulated mAbs and ADCs.⿢Direct injections of 300 mAbs samples on a single narrow pore C18 column.⿢Size exclusion effect has potential for other formulation components in biologics.