Breakthrough technology enables faster development of optimised freeze-drying cycles

SP Industries has announced that Genevac now provides European representation of its FTS SMART Freeze-Dryer™ Technology, a breakthrough development tool that enables development scientists to accelerate and streamline the arduous task of developing freeze-drying cycles for protein-based therapeutics. SMART Freeze-Dryer Technology is available exclusively on the FTS LyoStar II R&D and Process Development freeze-dryer.

SMART Freeze-Dryer technology uses control algorithms developed by leading experts in freeze-drying technology at the University of Connecticut and Purdue University (USA). According to Rob Darrington, Business Development Manager, "In effect, this system equips any development scientist with the collective knowledge of some of the world's leading lyophilisation experts."

SMART Freeze-Dryer Technology enhances freeze-dry cycle development is several important ways. Traditional cycle development relies on the experience and intuition of the development scientist, along with a trial and error approach. This often requires weeks of development time, and multiple test cycles can consume scarce and valuable active ingredients. SMART technology enables the developer to generate the right cycle on the first attempt. Due to the trial-and-error approach used in conventional freeze-dry cycle development, it is common practice for scientists to build-in "safety factors" in their cycles to ensure product integrity. By adding this safety margin, it is estimated that most production lyophilisation cycles are excessively long, often by several days. SMART Freeze-Dryer technology allows the development scientist to create a streamlined but safe cycle that can shave days off the production cycle. This efficiency gain can eliminate production bottlenecks, expand capacity and reduce production costs.

Data analysis on traditional freeze-drying cycles requires careful sampling and hours of detailed calculations by an experienced freeze-drying scientist. SMART technology features a unique feedback loop that provides detailed data on the pharmaceutical product and the freeze-drying process, including product resistance, heat flow and product thickness. Ready-access to such data can enhance scale-up efforts, provides a data trail for regulatory compliance, and frees-up valuable scientist time for other tasks.