Pharmaceutical freeze drying has a reputation of being an expensive and time-consuming process, but the latest freeze drying innovations are saving money and time, as well as changing the face of freeze drying forever. At Millrock, we are committed to developing these innovations, and pleased to announce a new partnership with researchers at Purdue University who are working toward more cost-efficient manufacturing through automated lyophilization.
Purdue’s School of Aeronautics and Astronautics recently received a National Science Foundation grant of $750,000 to develop real-time sensor technologies, computational modeling, and bioanalytical tools for closed-loop lyophilization. Millrock provided the freeze drying technology researchers are using for the NSF project at LyoHub in Purdue’s Discovery Park.
“Millrock Technology is excited to work with Purdue on this project,” says Millrock president T.N. Thompson. “The sensors and concepts proposed by Purdue in combination with the techniques and technologies developed by Millrock throughout the years is promising to produce major improvements in the freeze drying process. Better process control through continuous measurement of critical process parameters will enable maximum throughput while keeping the pharmaceutical product safely below its critical temperature.”
Co-PIs on the project include Timothy Peoples, the managing director of Purdue Foundry; Dimitrios Peroulis, the Michael and Katherine Birck Head of the School of Electrical and Computer Engineering; and Elizabeth Topp, founding co-director of LyoHub and professor in industrial and physical pharmacy. Research will also involve AAE graduate students Gayathri Shivkumar and Andrew Strongrich, whose models and sensor designs are elemental to the project.
Current freeze drying methods lack real time control or measurements, and inputs are fixed at a constant value. A typical production lyophilization cycle can take up to two weeks, because without in-process product monitoring and closed-loop control, the cycles are overly conservative and lengthy.
With sensors delivering real-time measurements, the use of heat transfer models, and the ability to constantly change the conditions inside the freeze dryer, the cycle can be optimized. The result: significant time and cost savings. Purdue’s project aims to create and implement a closed-loop “autopilot” system in which product state measurements are taken during drying and fed back into a controller. Purdue’s team believes this type of system could cut freeze drying cycle time by as much as 50 percent.
The battery-powered sensors, which are inserted into vials among the batches, measure pressure in order to determine the sublimation rate, then broadcast results wirelessly in real time into a model that inputs into the code.
“It can determine then how to adjust the dryer such that we’re right on the brink of that collapse temperature but never exceeding it. Because the warmer we go, the faster we dry. That’s what it comes down to,” Andrew Strongrich says. “Nothing like this sensor exists out there for this.”
Millrock Technology looks forward to sharing future updates about this innovative freeze drying project as it unfolds.
Quotes and initial reporting courtesy of the Purdue University School of Aeronautics and Astronautics.
See full article from Purdue University School of Aeronautics and Astronautics at https://engineering.purdue.edu/AAE/spotlights/2019/2019-0429NSFGrant