Analytical Chemistry

Synergy Bioscience has the expertise in developing analytical methods for a wide range of drug products, including small molecules and large protein molecules.

Services offered

  • Development of analytical methods for release testing.
  • Development and execution of characterization methods
  • Comparability studies
  • Purification and characterization of isomers, impurities, and degradants
  • In-process support during process development
Clinical Research

Analytical Methods

  • SDS-PAGE or capillary electrophoresis-SDS
  • Isoelectric focusing (gel-based cIEF or imaged cIEF)
  • Ion-exchange HPLC
  • Size-exclusion HPLC
  • Reversed-phase or hydrophobic interaction HPLC
  • Host cell protein (HCP) ELISA
  • Residual DNA
  • Endotoxin
Primary Structure
  • Western blot
  • N-terminal Amino Acids sequencing
  • Peptide mapping for detailed primary sequence analysis by LC-MS/MS
  • Characterization of post-translational modifications by LC-MS/MS
Carbohydrate Analysis
  • Monosaccharide composition analysis
  • Sialic acid quantitation
  • N-linked glycan profiling (fluorescent HPLC and CE-LIF
  • Detailed glycan structural analysis by MALDI-TOF-MS and ESI-MS/MS
Functional Assays
  • Cell-based bioassay
  • Binding ELISA
  • Surface plasmon resonance (BIAcore) and isothermal titration calorimetry (ITC)
Protein Mass
  • High-resolution intact protein mass measurement by LC-ESI-MS
  • Intact protein mass measurement by MALDI-TOF-MS
Conformational Analysis
  • Circular dichroism (CD)
  • Fluorescence
  • Fourier transform infrared spectroscopy (FTIR)
Aggregation Analysis
  • Dynamic light-scattering (DLS)
  • Size-exclusion chromatography with multiangle laser light scattering (SEC-MALLS)
  • HIAC liquid particle counting system
Physical Properties
  • PH
  • Osmolality
  • Residual moisture by Karl Fischer
Process Residuals
  • Process residual analysis by spectrophotometric assay
  • HPLC, ELISA, or LC-MS/MS, including surfactants, methotrexate
  • Host cell protein (HCP)
  • Residual DNA (qPCR)
  • Endotoxin

To discuss how Synergy Bioscience can help you, please contact us