Recombinant NY-ESO-1 cancer antigen: production and purification under cGMP conditions

Prep Biochem Biotechnol. 2005;35(2):119-34. doi: 10.1081/pb-200054732.


The cancer-testis antigen, NY-ESO-1, has been engineered into a bacterial expression plasmid which incorporates a His6-tag. The plasmid was transfected into E. coli strain BL21 and Master and Working cell banks generated from this expression system. Three 15-litre fermentations were performed under cGMP (code of Good Manufacturing Practice) conditions and the crude NY-ESO-1 tagged protein isolated as solubilised inclusion bodies. A three-step cGMP chromatography process (immobilised metal affinity, anion exchange, and hydrophobic interaction) was utilised to purify the protein. The purified NY-ESO-1 is being used in early stage human cancer vaccine trials in Australia and the U.S.A.

Publication types

  • Evaluation Study

MeSH terms

  • Antigens, Neoplasm / biosynthesis*
  • Antigens, Neoplasm / genetics
  • Antigens, Neoplasm / isolation & purification*
  • Antigens, Neoplasm / therapeutic use
  • Australia
  • Cancer Vaccines / biosynthesis*
  • Cancer Vaccines / genetics
  • Cancer Vaccines / isolation & purification*
  • Drug Industry / standards
  • Guidelines as Topic
  • Humans
  • Membrane Proteins / biosynthesis*
  • Membrane Proteins / genetics
  • Membrane Proteins / isolation & purification*
  • Membrane Proteins / therapeutic use
  • Protein Engineering / methods*
  • Protein Engineering / standards
  • Quality Assurance, Health Care / standards
  • Recombinant Proteins / biosynthesis
  • Recombinant Proteins / isolation & purification
  • Reference Standards


  • Antigens, Neoplasm
  • CTAG1B protein, human
  • Cancer Vaccines
  • Membrane Proteins
  • Recombinant Proteins