Titer and charge-based heterogeneity multiattribute monitoring of mAbs in cell culture harvest using 2D ProA CEX MS.

Abstract in brief

• The study introduces a new 2D liquid chromatography and mass spectrometry (2DLC-MS) method that combines Protein A chromatography for titer measurement with cation exchange chromatography for charge variant analysis, all in a single workflow, making the process quicker and more efficient than traditional methods.
• The new technique uses volatile salts compatible with MS, reducing analysis time from 60–90 minutes to about 15 minutes per sample, while providing detailed charge variant profiles similar to conventional methods.
• This method successfully quantified charge variants across a broad range of mAb concentrations and was effective in analyzing both the original mAb and its biosimilars, demonstrating its potential for rapid biosimilarity assessments in biopharmaceutical development.