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)