FTS Systems announces the introduction of SMART Freeze-Dryer™ Technology, a breakthrough development tool that enables skilled 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 LyoStar II R&D and Process Development freeze-dryer from FTS.
Smart Freeze-Dryer technology utilizes control algorithms developed by leading experts in freeze-drying technology at the University of Connecticut and Purdue University. According to Joe Brendle, Director of Process and Business Development, "In effect, this system equips any development scientist with the collective knowledge of the world's leading lyophilization thinkers."
SMART Freeze-Dryer Technology is expected to enhance freeze-dry cycle development is several important ways:
Faster Cycle Development: Traditional cycle development relies on the experience and intuition of the development science, 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.
Optimized Cycles: 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 lyophilization 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.
Process Feedback Data: 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 endeavors.
Leslie Mather, Product Manager for Lyophilization Products, commented, "We have never seen a new freeze-drying development generate as much excitement as SMART technology has. Every customer who sees this finds a new way it can help. This technology is truly unleashing the power of the lyophilization professional."
SMART Freeze-Dryer Technology is the result of a development partnership and an exclusive licensing agreement with the University of Connecticut (UConn) and Purdue University.
The research that led to the technology was directed by Dr. Michael J. Pikal, (UConn School of Pharmacy) and Dr. Steven Nail (formerly at Purdue University, School of Pharmacy, currently with Eli-Lilly). Major contributors to the research also included Dr. Nathaniel Milton, (formerly at Purdue, currently with Eli-Lilly) and Dr. Charlie Tang (formerly at UConn). The research was funded by the Center for Pharmaceutical Processing Research (CPPR).