Radiolabeling kit and binding assay

摘要

A method for radiolabelling a chelator-conjugated antibody comprises (i) mixing chelator-conjugated antibody with a solution containing a therapeutic radiolabel and (ii) incubating the mixture for a relatively short amount of time at an appropriate temperature to produce radiolabelled antibody having greater than 95% radio incorporation, sufficient specific activity and at least 70% immunoreactivity such that it may be administered directly to a human patient with out further purification of the radiolabelled antibody from unincorporated radiolabel; and optionally (iii) diluting the labelled antibody to an appropriate concentration in formulation buffer for administration to a human patient without further purification of the radiolabelled antibody from unincorporated radiolabel, with the proviso that when the antibody is an anti-CD20 antibody the labeled antibody is not diluted. Preferably the chelator is selected from MX-DTPA, phenyl-DTPA, benzyl-DTPA, CHX-DTPA and DOTA and the radiolabel is Y90 chloride. (62) Divided out of 513788