Analytical Testing

According to regulatory guidelines, extensive structural and functional analysis of a molecule is necessary to establish a well-characterized biologic or to demonstrate comparability between a biosimilar and reference product. Charles River has worked with a broad spectrum of molecules, including small molecules, peptides, lipids and glycoproteins. Our analytical testing laboratories provide both routine and custom analytical methods. These methods, conducted with state-of-the-art instrumentation, are available as a package or as individual services.

Chromatographic Services

  • N- & O-Linked Oligosaccharide Profiles
  • Sialic Acid Quantification
  • Monosaccharide Profile Analysis
  • SEC - Size / Aggregation Analysis
  • Purity, Identity, and/or Quantitation methods
  • Development of Stability-Indicating Methods
  • Residuals / Impurities / Degradants Analysis
  • Separation Technologies: RPC, SEC, HILIC, HIC, SAX, SCX, NP, WCX, WAX
  • Detectors: UV, VIS, DAD, CAD, ELSD, Fluorescence, Conductivity, PAD

Electrophoresis

  • Capillary Electrophoresis w/ LIF, UV/VIS
  • SDS-PAGE - Reducing / Non-Reducing
  • Isoelectric Focusing (IEF)
  • IPG Strips (immobilized pH gradient)
  • Densitometry
  • Immuno / Western Blotting

Spectroscopy

  • UV/VIS Absorbance
  • Fluorescence
  • Fourier-transformed Infrared
  • Circular dichroism

Activity / Potency Assays

  • Cell-based
  • Surface Plasmon Resonance - Biacore
  • ELISA with various modes of detection:
    • Colorimetric / Spectrophotometric
    • Fluorescence
    • Fluorescence Polarization
    • Time-resolved fluorescence (Delphia assay)
    • Luminescence
    • Chemiluminescence

Amino Acid Analysis (AAA)

  • Extinction Coefficient Determination
  • Mole Percent Amino Acid Analysis
  • Timed Hydrolysis Studies
  • Gamma Carboxyglutamic Acid (GLA)
  • Tryptophan Determination
  • Lysine Quantification for Polylysine Formulations
  • Collagen Hydroxyproline and Hydroxylysine Ratio Determinations

N-Terminal Sequencing

  • Automated Edman Degradation
  • De novo Sequencing
  • Pyroglu deblocking of N-Terminus
  • GMP Drug Substance ID Testing
  • Truncation / Multiple N-Termini Determination
  • SDS PAGE + PVDF Sample Prep for Multiple-Subunit Sequencing

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