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Ana. Characterization

We offer Protein/product characterization by various routine techniques as well as specialized tests for CMC dossier.

The various testing for protein characterization include but not limited to:

  • Electrophoresis: SDS PAGE, Isoelectric focusing, Western blot
  • Chromatography: RP-HPLC, SE-HPLC, IE-HPLC (Using multiple platforms like Agilent, Waters and others)
  • Peptide Mapping: RP-HPLC and UPLC
  • Host cell protein analysis
  • Residual DNA determination (qPCR, Fluorescence dye based techniques)
  • Protein Quantification
  • Protein A leachable quantitation
  • Specific method development for the impurity characterization of protein therapeutics