Rapid Miniaturized Chromatography Procedures for Iodinated Monoclonal Antibodies: Comparison to Gel Exclusion Chromatography

Chromatographic quality control testing of radioiodinated monoclonal antibodies (WJ MOAB) is necessary to assess radiochemical purity prior to patient injection. Conventional gel exclusion chromatography column scanning (GCS) is time consuming and not practical. We investigated rapid miniaturized chromatographic procedures for evaluating the radiochemical purity of 1311 MOAB. Three systems were evaluated using Gelman JTLC-SG and three solvents: acetone, 85% methanol, and 0.9% NaCI. Radiochemical analysis was performed on Nai3IJ of high radiochemical purity and Nai3IJ containing radiochemical impurities, as well as three I3IJ MOAB preparations. Five separate measurements were obtained for each preparation and solvent, and the results were compared to GCS. The results demonstrated ITLC-SG and 0.9% NaCI was most accurate in assessing radiochemical purity when compared to GCS. With the ITLC-SG and acetone system, and to a lesser degree, the ITLC-SG and 85% methanol system, no separation between I3IJ iodate/ periodate and /3/f MOAB was achieved, resulting in some instances in the overestimation of the radiochemical purity of the I3IJ MOAB.