Understanding the specific environmental conditions that destabilize your protein is the goal of pre-formulation studies. These studies are designed to learn about the protein's susceptibility to a variety of relevant stresses, determine potential degradation pathways of the product. Based on results, then develop a baseline biophysical profile.

Common environmental variations are

  • • pH
  • • Temperature
  • • Ionic strength
  • • Stress
  • • Freeze-thaw cycles