Immunoreactivity assay for alpha-particle emitting monoclonal antibody constructs.

Clinical trials using alpha-particle radiolabeled antibodies require a rapid and reproducible assay of the immunoreactivity of drugs. While live cell assays are typically used to determine the immunoreactive drug fraction, a fixed cell assay may replace the traditional live cell assay and offer the advantages of rapidity, easy availability and consistency for qualifying drugs for preclinical or clinical studies. We have identified optimal cell fixation and immunoreactivity assay conditions and have validated them by performing the fixed-cell assay in clinical trials.