Stability and forced degradation studies
Understanding the stability of a drug product is crucial in all development phases
Stability testing and forced degradation studies (stress testing) play a central role in almost all development phases:
During preformulation studies and formulation development, forced degradation is essential to understand the criticality of certain types of stress for the drug substance and to identify the most robust and stable formulation during development. The presence of a stressed and (partially) degraded sample is also the basis of any comprehensive analytical method development that allows for the quantification of undesired by-products. For the development of biosimilar drug products, the physico-chemical comparability, including comparability of stability profiles, is required. Among other scenarios, such comparability studies can also be crucial when comparing samples from different production processes or manufacturing facilities. During developability and manufacturability assessment it is further crucial to simulate certain stress scenarios, including in-use stability. Finally, it is required to test the long-term stability of a drug product using the desired storage conditions, e.g. as defined by the ICH.
We at Coriolis have over 12 years of experience with stability and forced degradation studies and our scientists are eager to apply their knowledge to support your drug development program.