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Biopharmaceutical analyses

 

Basic protein characterization

According to the ICH-Q6B guidelines, proteins or peptides should be characterized in terms of their visual appearance, molecular weight, isoelectric point, pH in solution, amino acid content, primary structure, and the presence of disulfide bridges.

List of currently available analytical techniques

  • Molecular weight
    • 1D gel electrophoresis (both SDS and native)
    • ESI-MS
    • Size-exclusion chromatography
  • Isoelectric point
    • Isoelectric focusing
    • Capillary isoelectric focusing
  • Amino acid content
    • Amino acid analysis (UPLC-UV)
  • Primary structure
    • ESI-LC-MS/MS
  • Disulfide bridges
    • UPLC-UV, LC-MS/MS