Analytic Method Development

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 quaternarystructure of biologically active proteins
  • Fourier Transformed Infrared Spectroscopy (FTIR)
  • Fluorescence Spectroscopy
  • Differential Scanning Calorimetry (DSC)

UPLC/HPLC methods

Monitors various degradation of protein 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)

Particle analysis

Identification and quantification of particulates
  • Flow imaging microscopy (MFI and Flowcam): excellent for sub-visible particles
  • Dynamic light scattering (Zetasizer, Wyatt)
  • HIAC Liquid Particle Counter

Viscosity

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

Other useful analytical methods

  • Subambient differential scanning calorimetry (characterization of frozen formulations)
  • Imaged capillary isoelectric focusing (icIEF)
  • Karl Fisher moisture titrator
  • Osmometry, SoloVPE