Fragments of protein A eluted during protein A affinity chromatography

J Chromatogr A. 2007 Sep 7;1163(1-2):105-11. doi: 10.1016/j.chroma.2007.06.012. Epub 2007 Jun 12.

Abstract

Protein A affinity chromatography is a common method for process scale purification of monoclonal antibodies. During protein A affinity chromatography, protein A ligand co-elutes with the antibody (commonly called leaching), which is a potential disadvantage since the leached protein A may need to be cleared for pharmaceutical antibodies. To determine the mechanism of protein A leaching and characterize the leached protein A, we fluorescently labeled the protein A ligand in situ on protein A affinity chromatography media. We found that intact protein A leaches when loading either purified antibody or unpurified antibody in harvested cell culture fluid (HCCF), and that additionally fragments of protein A leach when loading HCCF. The leaching of protein A fragments can be reduced by EDTA, suggesting that proteinases contribute to the generation of protein A fragments. We found that protein A fragments larger than about 6000 Da can be measured by enzyme linked immunosorbent assay, and that they can be more difficult to clear than whole protein A by cation-exchange chromatography.

MeSH terms

  • Chromatography, Affinity / methods*
  • Chromatography, Ion Exchange
  • Enzyme-Linked Immunosorbent Assay
  • Peptide Fragments / chemistry
  • Staphylococcal Protein A / chemistry*

Substances

  • Peptide Fragments
  • Staphylococcal Protein A