Sensitive Method for LC Analysis of Therapeutic Monoclonal Antibodies Using a Centrifugal Filtration Device with Adsorption Suppression Treatment

Abstract

Herein, we report an intact LC–native fluorescence analysis method for therapeutic monoclonal antibodies (mAbs) based on a centrifugal filtration device with adsorption suppression treatment. Coating the centrifugal filtration device with MPC monomer suppressed the non-specific adsorption of mAbs, especially in the low concentration range; trastuzumab could be quantitatively and sensitively analyzed in the 0.2–10 μg/mL range. In this analysis, the average concentration factor over the entire concentration range was approximately 25 times. The other mAbs (bevacizumab, rituximab, nivolumab) also showed good linearity with R² ≥ 0.996, and the average concentration factors were similar to that obtained for trastuzumab. This method can potentially be used in combination with affinity purification for simple and sensitive bioanalysis.