To meet the regulatory expectation of any biopharmaceutical development program you need to characterize the drug substance/drug product stability through forced degradation and exposure to severe conditions (i.e., stress testing). Studies may include the following:
- Thermal denaturation
- pH acid/base
- Ionic strength
- Mechanical shear
At Envigo, we can help you determine the intrinsic stability of your product and the degradation pathways. We also enable you to identify and elucidate the structures of degradative products and establish which analytical techniques are truly stability-indicating.