Product Quality

The cornerstone of any product development and manufacturing effort is the analytical characterization of the product and testing of all raw materials, bulk solutions, in-process materials, and finished product.

Our well-designed analytical programs satisfy regulatory requirements to assure the success of the clinical program. Our dedicated analytical scientists customize phase-appropriate analytical programs to the specific needs of your unique molecule, delivering a comprehensive understanding and characterization of the molecule for each stage of development and commercialization.

Analytical Capabilities

Our on-site laboratories are equipped with sophisticated analytical instrumentation, enabling scientists to employ a full range of methodologies and techniques to characterize your product and develop test methods that will validate your product’s integrity throughout its life cycle.

Primary Structure Analysis

  • Peptide mapping via UV-HPLC or LC/MS/MS (QTOF, Ion Trap)

Biophysical Characterization

  • Multi-angle light scattering (MALS)
  • Fourier-Transform infrared spectroscopy (FTIR)
  • Scanning calorimetry (DSC)
  • Dynamic light scattering (DLS)
  • UV/VIS spectroscopy
  • Electrophoretic mobility (Zeta-potential)

Glycan Analysis

  • Monosaccharide composition
  • Oligosaccharide mapping
  • Sialic acid quantitation


  • Size-exclusion chromatography
  • Ion-exchange chromatography
  • Affinity-based chromatography
  • Reversed-phase chromatography

Capillary and Conventional Gel Electrophoresis

  • Capillary isoelectric focusing (cIEF)
  • SDS-PAGE and AGE
  • Western blot
  • Dot blot

Process Residuals

  • qPCR
  • HPLC (antibiotics, IPTG, surfactants, etc.)

Potency Assays

  • Enzymatic activity assays

Particulate Analysis, Including Sub-10 Micron Particle Characterization

  • Asymmetric-flow field flow fractionation (A4F)
  • Sub-10 micron particle characterization

Mass Spectrometry (QTOF, ION TRAP)

  • Intact mass mapping
  • Disulfide mapping
  • PEGylation site identification
  • Peptide mapping with LC/MS or LC/MS/MS
  • Identify post translational modifications (oxidation, deamidation)
  • Glycan characterization & linkage-site identification