Analytical Chemistry

At Synergy, our mission is to provide you with the analytical solutions you need to achieve your drug development goals quickly and easily. We have the expertise in developing analytical methods for a wide range of drug products, including chemical molecules and therapeutic protein molecules.

 

Services offered

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

Analytical Methods

Purity
  • 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
Primary Structure
  • Western blotting
  • 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 Orbitrap LC-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-MS/MS
  • Intact protein mass measurement by UHPLC
Conformational Analysis
  • Circular dichroism (CD)
  • Fluorescence
  • Fourier transform infrared spectroscopy (FTIR)
Aggregation Analysis
  • Size-exclusion chromatography with multiangle laser light scattering (SEC-MALLS)
  • HIAC liquid particle counting system
Physical Properties
  • Residual moisture percentage & water content by Karl Fischer measurement
Process Residuals
  • Process residual analysis by spectrophotometric assay
  • HPLC or LC-MS/MS
  • Host cell protein (HCP)
  • Residual DNA (qPCR)
  • Residual Solvents by Headspace GC-FID or GC-TCD