High-Throughput Intact Mass Analysis Of mAb-Based Therapeutics

Intact mass analysis of biotherapeutic proteins using mass spectrometry is a key characterization technique performed from upstream drug development to downstream product analysis. It is routinely used for sequence confirmation, clone screening, glycoform quantification, and to assess purity and heterogeneity during product quality control screening.

ZipChip’s method for intact mAb analysis using denaturing conditions is the simplest and most universal method for intact protein analysis using the platform. The low pH of the BGE effectively mobilizes and ionizes intact proteins resulting in high-quality mass spectra with fast run times. Additionally, it is very tolerant of sample matrix components, such as salts and detergents, so there is generally little to no sample prep necessary.

In this work we demonstrate the high throughput analysis of monoclonal antibodies. Migration times on the order of 0.5 min are obtained and glycoforms of the mAbs are identified from concentrations ranging 1 mg/mL to 1 μg/mL. Overall, the ZipChip method for intact mass analysis is a simple, high-throughput approach that can facilitate rapid MS characterization of biotherapeutic proteins.