Protein Stability/Degradation Studies
Soluble Biotech provides comprehensive protein stability analysis via time-dependent shelf-life studies and forced degradation studies.
Evaluation variables include pH, temperature, humidity, light, oxidizing agents and mechanical stress. Our programmable incubators can assess the effect of temperature changes from -20°C to is high as 90°C, changes in humidity from 20% to is high as 70%. We also assess:
- pH from 4.0-11.0
- Photo stability at 1.2 million lux hours and an integrated near ultraviolet energy of not less than 200 W hours per square meter (or milder conditions depending on the molecule)
- Oxidizing agents (i.e. H2O2)
- Mechanical stress via sample agitation (shaker or centrifugation from 700 to 1500 rpm)
Protein and peptide degradation products are identified using a variety of biophysical techniques including:
- Size Variants: size exclusion HPLC, SDS-PAGE, native SDS gels, isoelectric focusing
- Charge Variants: isoelectric focusing
- Primary Structure Degradation Products: Deamidation, Oxidation: LC mass spectrometry
- Higher Order Structure: differential scanning calorimetry, circular dichroism, dynamic light scattering
- Visual Analysis: appearance of visible and sub-visible particles, turbidity, color changes