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)

Did you know…?

Clinical use periods have been accepted by health authorities using just ASAPprime® modeling.

Learn more here.