Implementing an Accelerated Stability Assessment Program: Case Study

The Accelerated Stability Assessment Program (ASAP)


  • Modeling tool used in development that improves product degradation understanding
  • Has been shown in the literature to provide credible predictions for shelf life/product expiry estimations
  • Faster than conventional stability and package screening studies

How Lilly is Currently Implementing the Program


  • Small group of scientists and statisticians assembled to assess ASAP and develop a pilot process/implementation plan
  • Information repository developed that included literature articles (or references) and presentations to help educate scientists/statisticians
  • A defined process and Excel based tools were developed to facilitate implementation
  • Integration with existing package modeling tools

How Lilly is Improving the Program


  • Seek interest and build expertise across specialty areas (cross-functional Subject Matter Experts)
  • Assess implementation and impact of using ASAP to portfolio
  • Share case studies and learning (results, predictions, etc.)
  • Improving processes, tools (including software purchase), and study execution
  • Can help leverage getting needed resources for studies to intentionally explore failure modes

ASAP approach


  • Scientifically selected accelerated conditions targeting the same amount of degradation for each condition (isoconversion)
  • Extrapolation to real time conditions is often very good
  • Package selection can be determined through the combination of the product degradation kinetics (ASAP) and package modeling, eliminating the need of package screening studies
  • Can help guide the control strategy (e.g. initial water activity limits, packaging configurations, Genotoxic Impurity Strategy)