2/18/18 LyoHub

Evan Liechty, a senior in the College of Engineering who is in professor Alina Alexeenko’s research group, prepares samples to run in a lyophilizer. Liechty is running the samples for Baxter, a corporate member of LyoHub.

“This whole industry is very much stuck in the ‘60s and ‘70s,” said Drew Strongrich, a Ph.D. student in aeronautical and astronautical engineering.

Strongrich spoke eagerly about his work as he walked around the room, pointing out various sensors and instruments.

He is working on improving a technology known as “lyophilization.” It refers to a freeze-drying process that is important for many pharmaceutical and food manufacturing applications. Removing water from various products can improve their shelf life. Water is traditionally removed from products by heating the product and evaporating water vapor. However, many products, including certain drugs and foods, cannot withstand the required heat, so another method is required.

Under low pressure and temperature conditions, ice can directly convert to water vapor in a process called sublimation. Lyophilization uses sublimation to remove water from drugs and foods in machines known as lyophilizers. Drug companies especially rely on lyophilization to stabilize many drugs. However, there have been few advances in the technology in the past several decades.

“In my view, lyophilization is one of the least-known, most important technologies of the 20th century,” said Alina Alexeenko, a professor in the School of Aeronautics and Astronautics and Strongrich’s research advisor.

Alexeenko and Elizabeth Topp, a professor in the College of Pharmacy, are co-directors of LyoHub, a consortium of academic, private and public sector partners working to improve the technology and policy behind lyophilization.

One of the current issues with lyophilization technology is that lyophilizers tend not to have adequate sensors to measure parameters such as temperature and pressure. This makes it difficult to gather information about the vials in the lyophilizer during the process of lyophilization and determine when the process is done.

“It’s a little bit like you’re baking cookies at home,” Topp said. “You put the cookies in the oven, you close the door, and you bake them for 20 minutes because that’s what the recipe says you’re supposed to do. But you never open the door to see if they’re done.”

LyoHub has been working with engineers who have been developing sensors to measure various parameters within a lyophilizer. Strongrich works on developing sensors like this. He is currently working on developing a pressure sensor that is the size of a vial in a lyophilizer and broadcasts data over Bluetooth.

LyoHub has also developed a technology road map to guide innovation over the next several years. Other than research to improve lyophilization, LyoHub is also working on education and policy aspects of lyophilization.

Topp explains that regulations from the Food and Drug Administration on lyophilization technology make companies reluctant to innovate due to the time and effort to get innovations approved. Thus, academic and corporate members of LyoHub are working on developing standards that the FDA can use to streamline the process for approving innovations.

Topp’s research group is working on developing analytical methods that allow one to determine long-term stability of molecules more quickly so that stability studies won’t require several months to complete.

Corporate members of LyoHub have also expressed a desire for education on lyophilization. In 2016, LyoHub opened a demo facility in the Birck Nanotechnology Center that corporate members of LyoHub can use to learn about lyophilization and how to use it. Furthermore, LyoHub has developed a course, LYO 101, to teach people from corporate partners of LyoHub about lyophilization.

Although Strongrich’s background is in engineering, he appreciates how other individuals can bring a biochemical or pharmaceutical perspective to LyoHub.

“It’s cool to come together and cross-collaborate,” Strongrich said. “We all have different expertise. It makes it a very multidisciplinary problem, which is a lot of fun.”

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