Purdue forms consortium to advance freeze-drying technology

September 30, 2015

Purdue University has created a new lyophilization consortium, LyoHUB, to improve freeze-drying technology to make food, pharmaceuticals, and biotech products safer and more affordable. The center is funded by the National Institute of Standards and Technology through a $453,623 planning grant from its Advanced Manufacturing Technology Consortia, or AMTech, program.

Lyophilization, the process by which water is gently removed from materials to make them more stable and lengthen their shelf life, is a high-priority technology challenge, said Elizabeth Topp, head of Purdue’s Dept. of Industrial and Physical Pharmacy who co-leads the center with Alina Alexeenko, an associate professor of aeronautics and astronautics.

“You don’t think of it when enjoying the dried strawberries in your morning cereal, but lyophilization is a $30 billion piece of the U.S. food and pharmaceutical manufacturing industry,” said Topp. “Many protein-based drugs, certain vaccines, probiotics, and the dried fruit used in many products would not be available without it. However, the current lyophilization process hasn’t changed in 50 years, and it is very expensive.”

The lyophilization process requires big pieces of equipment that create a low temperature and pressure environment to push water into the vapor phase, so that it leaves the material and collects on condenser coils. Since the equipment is sealed, and it is impossible to check on a process while it is occurring, except through information from one or two sensors. Processing one batch of material can take a few days, which means time is lost if something goes wrong.

The development of new sensors that are less bulky and better distributed within the system is one approach to help control the processing. Advancing process analytical technologies and sensors for process development, monitoring, and control are one of the initial focuses of the consortium, as well as developing standards for lyophilization equipment performance, testing, and validation.

“Consortium members from industry will frame the problems they face, and members from the academic and research side will help work on solutions, while regulators are kept in the loop to ensure the safety and standards so that changes can be quickly approved,” said Topp. “We want to entirely rethink and redesign how the processing is done, which will have the ripple effect of improving pharmaceutical manufacturing in general. We can apply what we learn to make other manufacturing processes better, faster, and more efficient. This will mean safer and more affordable products.”

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