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Analytical solution

  Amino acid composition
  Peptide mapping for protein sequence identification
  N/C terminal sequence identification
  Molecular weight determination
  Capillary electrophoresis
  Isoelectric focusing
  Protein electrophoresis/2D electrophoresis
  Reversed phase/ size-exclusion chromatography/ ion exchange/ hydrophobic interaction chromatography
  Evaluation of the percentage of N- and O-link glycan site occupancy.
  Carbohydrate composition
  Glycosylation site determination
  Quantitation of all glycan variants
  Disulfide bond pattern
  Far/Near UV circular dichroism (CD)
  In vitro potency assay
  In vivo potency assay
  Surface plasmon resonance (SPR) analysis

  Physicochemical characterization
  Forced degradation study
  pH & buffer screening study
  Excipient screening study

  Optimization of formulation parameters
  Lyophilized formulations
  API/Finished product optimization


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