Charge heterogeneity profiling of monoclonal antibodies using low ionic strength ion-exchange chromatography and well-controlled pH gradients on monolithic columns.

@article{Talebi2013ChargeHP,
  title={Charge heterogeneity profiling of monoclonal antibodies using low ionic strength ion-exchange chromatography and well-controlled pH gradients on monolithic columns.},
  author={Mohammad Talebi and Anna Nordborg and Andr{\'a}s G{\'a}sp{\'a}r and Nathan A Lacher and Qian Wang and Xiaoping Z He and Paul R Haddad and Emily Frances Hilder},
  journal={Journal of chromatography. A},
  year={2013},
  volume={1317},
  pages={148-54}
}
In this work, the suitability of employing shallow pH gradients generated using single component buffer systems as eluents through cation-exchange (CEX) monolithic columns is demonstrated for the high-resolution separation of monoclonal antibody (mAb) charge variants in three different biopharmaceuticals. A useful selection of small molecule buffer species is described that can be used within very narrow pH ranges (typically 1 pH unit) defined by their buffer capacity for producing controlled… CONTINUE READING