Analytical Method Capabilities

Formulation attributes can be achieved only when informative analytical methods are available. It is important to wisely select analytical methods that are both relevant and sensitive to the specific issues faced with your unique molecule. Listed below are examples of analytical methods that Integrity Bio utilizes to characterize formulations.

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Structural analyses

Measures the secondary, tertiary, and quaternary structure of biologically active proteins
  • Fourier Transformed Infrared Spectroscopy (FTIR)
  • Differential Scanning Calorimetry (DSC)
  • Fluorescence Spectroscopy

UPLC/HPLC methods

Monitors various degradation of biological therapeutics
  • Size-exclusion
  • Ion-exchange (cation-exchange, anion-exchange)
  • Reversed Phase
  • Hydrophobic Interaction
  • Various detectors: UV, Fluorescence, reflective index, evaporative light scattering

Electrophoresis

Separates impurities based on both charge and mass
  • Capillary Electrophoresis (CE)
  • Sodium dodecyl sulfate electrophoresis (SDS-PAGE)

Viscosity

Measurement for manufacturing process as well as injection through narrow bore needles
  • Rheometer
  • Instron
  • M-VROC

Subvisible Particle Analysis

The potential immunogenicity of particles ranging from nanometer to micron sizes in biotherapeutics has been a growing area of discussion between regulators and industry. Both the USP and Ph.Eur. currently require biopharmaceutical products to quantify subvisible particles larger than 10 µm and 25 µm, respectively.

Due to the complex milieu of subvisible particles, sample preparation and the method of analysis can affect the accuracy of:

  • Particle Sizing
  • Particle Counting
  • Particle Classification

Consequently, multiple orthogonal techniques are strongly recommended for subvisible particle analysis. Integrity Bio offers multiple orthogonal techniques for subvisible particle characterization:

  • Flow Imaging Microscopy (MFI and Flowcam)
  • Dynamic Light scattering (Zetasizer, Wyatt)
  • HIAC Liquid Particle Counter
  • Light Obscuration

Other Useful Analytical Methods

  • Subambient differential scanning calorimetry (characterization of frozen formulations)
  • Imaged capillary isoelectric focusing (iCIEF)
  • Karl Fisher
  • Osmometry
  • SoloVPE