Scientists in the r&d divisions of a large pharmaceutical company and a blue-chip biotech firm have piloted a breakthrough tool that enables development scientists to accelerate and streamline the arduous task of developing freeze-drying cycles for protein-based therapeutics.
The r&d labs spent several months using SMART Freeze-Drier Technology for freeze-drying cycle development work. Each lab used the system to develop an optimised cycle for a single formulation and then compared the SMART approach with their traditional cycle development protocol. Their work was studied to identify the gains achieved using the new technology.
According to the developer all three labs reported breaking even on their investment in the new technology in less than three months. The primary savings were achieved through the technology's ability to deliver optimised freeze-dry cycles after just a few experimental runs. The average reduction in experimental cycles at the three labs was 78%.
Average savings per development programme were US$40,000 (Euro 25,743), consisting primarily of labour savings and active ingredient materials savings. Average annual savings were $320,232 ( €206,075) based on an average of eight development programmes per year.
In addition, because scientists were often able to produce a cycle optimised to their specifications after a single experimental run, the technology enabled them to conduct additional experiments to test for process limits while still shaving months off the development programme.
It is important to note that two other important economic considerations were not quantified in this study. These are:
- The value of advancing a formulation to pilot production months faster.
- The production savings available by developing a more efficient, more robust freeze-drying cycle. These savings would be considerable for any formulation that advances into pilot or commercial production.
SMART Freeze-Drier Technology packages control algorithms developed by leading experts at the University of Connecticut and Purdue University into an easy-to-use cycle development tool. The user enters basic data, and SMART returns a safe, optimised drying cycle after just one or two development runs.
It also generates process data - such as product resistance and heat flow - not previously available from a freeze-drying system.
The technology takes the guesswork out of freeze-drying cycle development and thus saves development time, eliminates product waste, and gets products to market faster, the company says. It also safely produces streamlined cycles that shave days off the typical freeze-drying process.
SMART is available on LyoStar II R&D and Process Development Freeze-Driers from FTS Systems.