Biophysical Characterization

Many of our biophysical characterization methodologies examine a product's higher-order structure (HOS), which may include secondary and tertiary structure, aggregation and oligomerization. Correct HOS configuration is critical to ensure proper functionality, activity and stability of a biopharmaceutical product. Secondary and HOS characterization capabilities are essential for a complete product characterization program.

Secondary and Higher-Order Structural Characterization Methods

  • Analytical Ultracentrifugation (AUC)
  • Circular Dichroism (CD)
  • Differential Scanning Calorimetry (DSC)
  • Size-Exclusion Chromatography (SEC) with Multi-Angle Laser Light (MALLS) Detection
  • Dynamic Light Scattering (DLS)
  • Intrinsic Tryptophan Fluorescence (ITF)
  • Extrinsic Fluorescence - Dye Binding (e.g., ANS)
  • Fourier Transform Infrared (FTIR) Spectroscopy
  • Surface Plasmon Resonance (SPR) via Biacore

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Biosimilar Development

Combining experience from across Charles River, we have developed a comprehensive program that can be used to support the development of many different biosimilars.