Stone Ridge, NY November, 2005
Contact: Leslie Mather
845.687.5315

FTS Systems announced today that it will officially introduce its breakthrough SMART Freeze-Dryer™ Technology at AAPS 2005 in Nashville.  FTS will be presenting the product at Booth 2605.

SMART Freeze-Dryer Technology is 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 immediately on all LyoStar II freeze-dryers from FTS, or as a retrofit to installed LyoStar II systems.

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 Leslie Mather, Product Manager for Lyophilization Products, “In effect, this system equips any development scientist with the collective knowledge of the world’s leading lyophilization thinkers.”

SMART Freeze-Dryer Technology enhances freeze-dry cycle development in several important ways:

Faster Cycle Development:  Traditional cycle development relies on the experience and in-depth knowledge of the development scientist, along with a trial and error approach. This often requires months of development time, and multiple test cycles can consume scarce and valuable active ingredients. According to Mather, “Customers are reporting that the normal cycle optimization which takes up to 3-4 months and 6-8 cycles can be brought down to a week or two with SMART.”

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. Mather reports that “beta test sites have reported cycle time reductions of nearly 50% in some of their more difficult products.”

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 ice thickness. Ready-access to such data can enhance cycle robustness, facilitate scale-up efforts, provide a data trail for regulatory compliance, and free-up valuable scientist time for other endeavors. Users expect SMART to be an invaluable PAT tool.

Dr. Henning Gieseler of the Department of Pharmaceutics at the University of Erlangen-Nuremberg in Germany, worked closely with FTS during the development and testing of the SMART system.  Dr. Gieseler commented, “I have never seen a new freeze-drying development generate as much excitement as SMART technology has.  During our extensive testing, every customer who participated discovered 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. Xiaolin (Charlie) Tang (formerly at UConn). The research was funded by the Center for Pharmaceutical Processing Research (CPPR). 

Additional Background

Freeze-drying (also referred to as lyophilization) is an important process step in the production of a number of important pharmaceutical products.  The continuing discovery and development of protein based therapeutics is increasing the need for methods that help improve freeze-drying and freeze-drying process development.

About FTS Systems: For more than 30 years, FTS Systems has been a leading maker of innovative R&D, process development and pilot scale freeze-dryers, and other thermal management systems.  Based in Stone Ridge, NY, FTS is a Celerity, Inc. company.

About LyoStar II Freeze-Dryers:   The LyoStar II is an R&D and process development freeze-dryer that provides unmatched process accuracy, reliability and unique ease-of-use features.  The LyoStar II features RTD-controlled shelf temperature accuracy of +/- 0.5°C or better and vacuum control within  0.1% of set-point.  Its robust 5.5 hp cascade refrigeration system enables shelf pull down from ambient to –40°C in less than 25 minutes, and the ultra-reliable scroll compressors feature just 3 moving parts .  LyoStar II’s unique integrated arm-mounted touchscreen controls enable the operator to manage and monitor operations at the unit.