Accelerated Stability for Shelf Life of Small Molecules and Biologics

Accelerated stability modeling has advanced significantly in recent years for both small molecules and biological drugs; however, many pharmaceutical scientists are not aware or have not adopted such time-saving methods.

This talk will benefit most analytical scientists, formulators, packaging engineers and people involved in regulatory CMC processes.

ASAP, the Accelerated Stability Assessment Program, employs isoconversion (time to hit the specification limit at each condition) with designed open temperature/relative humidity/oxygen levels based on a humidity and oxygen-corrected Arrhenius equation to build a model for degradant formation, potency/activity loss or changes in physical properties for small and large molecule drug products and drug substances. Once the stability model is built, the shelf life inside packaging can be determined based on the calculated RH (for solids) and oxygen level inside the packaging using package permeability, moisture balance (isotherms) and oxygen consumption. These methodologies provide for accurate predictions of shelf life in short time frames (2-8-weeks) with error bars (probability of passing at a given condition and time point) propagated conservatively to take into account the uncertainty in the measured values, the corresponding isoconversion times and ultimately the fitted Arrhenius parameters. This approach has been successfully used in regulatory filings in many countries to bring new drugs to patients faster.