A biotech company was looking to advance its experimental drug candidate into clinical trials in the United States. They asked FreeThink to determine which of three formulations they should proceed with.
We conducted a three-week ASAPprime® study on their drug product, analyzing for growth of drug-related substances.
We determined that there were two degradation products that limit the shelf-life. Based on their specification limits (0.5%), the mean shelf-life at 25°C/60%RH was at best only 0.9 years, even when packaged in bottles with desiccant. Removal of oxygen did not impact the rate of degradant.
We suggested the following: Use 5°C storage for Phase I clinical trials (mean shelf-life >10 years), then work to qualify the degradant to 1.0% (mean shelf-life 3.2 years at 25°C/60%RH with the best of the three formulations). These suggestions were successfully implemented.