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.

