Monitor Your mAb with Selectivity and Specificity for Upstream Bioprocessing

Antibodies are very complex compared to small molecule drugs and winning regulatory approval for innovator and biosimilar monoclonal antibody products can be challenging. Combining CE-SDS/cIEF with antibody-based immunodetection using Simple Western™ is more sensitive than traditional CESDS/cIEF platforms with native fluorescence detection. Plus, Simple Western provides accurate, quantitative results you won’t get with ELISA or Western blot, and results are ready in just 3 hours.

Trastuzumab (tradename Herceptin^®) is one of the earliest antibody-based therapies available for cancer treatment, and companies worldwide develop trastuzumab biosimilars. In this App Note, we describe a fast and easy Simple Western assay to characterize trastuzumab with results that are rich in quantitative detail. We show how protein separation on Simple Western uncovers cross-reactivity of the detection antibody with other IgG1 drug products, which may not be easy to identify using ELISA, and could produce misleading results.