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A Next-Generation Stability Budget for Refrigerated Biologics Through Statistical Simulation and Visualizations (309881)

Keywords: Medicine, Biologics, Stability, Simulation, Visualization, R, Shiny

The manufacture and distribution of cold-chain (refrigerated) drug products require that some operations be performed outside of recommended storage conditions. The duration and temperature of exposures outside of refrigeration must be monitored and controlled so that there is no impact to product quality. This control strategy includes planned exposures outside of refrigeration (e.g., packaging, patient-use period) and unforeseen exposure events (e.g., refrigeration equipment failure, extreme weather). These temperature excursions, plus time at the registered storage condition, are contributing components to the total acceptable magnitude of degradation that a biologics drug product may experience through expiry while remaining acceptable for patients. A next-generation stability budget quantifies the contributions of these components via statistical modeling and statistical simulation techniques that can incorporate the impact of operational performance during manufacture and distribution through the supply chain. An interactive analytics tool, coded in R/Shiny, is used to run the simulation analysis, providing visualizations to identify the limiting analytical properties.