Formulation Stability Assessment

Soluble Biotech provides comprehensive protein stability analysis via time-dependent shelf-life studies and forced degradation studies.

Long-term, intermediate and accelerated studies include:

  • Storage temperature and humidity conditions
  • Photostability (ultraviolet or visible light)
  • Transport stability (freeze and thaw, cycle test)
  • Customer-specific conditions

Assessments of physical and chemical degradation pathways:

  • Extreme pHs
  • Elevated temperatures
  • Photolysis
  • Mechanical-induced stress
  • Oxidizing agents

Methods of analysis including, but not limited to:

  • Size variants (e.g. aggregation, fragmentation): HPLC, SDS-PAGE, visible and sub-visible particles analyses
  • Charge variants: isoelectric focusing
  • Primary structure degradation products (e.g. deamidation, oxidation): LC-MS
  • Higher order structure: DSC, DLS, CD
  • Colorimetric changes: UV/Visible spectroscopy

To find out more about our stability testing services, contact us today.