In April 2022, Purdue University/LyoHUB received a NIST Advanced Manufacturing Technology Roadmap Program (MFGTech) award to develop Lyophilization, Freeze-Thaw and Aseptic Drying Technology Roadmap for Pharma/Biotech Manufacturing. The roadmap will expand the 2017 LyoHUB technology roadmap  to include novel freeze-drying, aseptic drying and freeze-thaw technologies and address new product modalities including cell and gene therapies, nucleotides (DNA, RNA) vaccines and therapeutics.

“The new project will build on LyoHUB’s successes and position the consortium for ongoing impact,” said Alina Alexeenko, founding co-director of LyoHUB, and professor of aeronautics and astronautics and chemical engineering. “In this next phase, we will expand our roadmap to include novel technologies and applications for emerging classes of therapeutics and vaccines, allowing the pharmaceutical industry to deploy effective medicines and vaccines more efficiently and rapidly.”

Lyophilization is used in manufacturing almost half of new biopharmaceuticals. Providing a sterile, vacuum environment to remove water from drug products after they are frozen, it converts the frozen moisture to a vapor, eliminating the liquid phase. This process increases the stability and shelf life of medications and eases their long-term storage and shipping.

“However, the process is highly complex and not time- or energy-efficient, with few fundamental changes since it was introduced for medical applications in the 1940s,” Alexeenko said. “We’re working to improve processes, products and equipment, for example, by using advanced computational simulations, analytical methods and new technologies such as radio frequency (RF)-assisted heating. Moving from batch processing to continuous freeze drying is one goal. Also, in the new project, we’ll be exploring other kinds of drying technologies to save time and money while preserving product integrity.”

Alexeenko leads LyoHUB with co-founder and co-director Elizabeth Topp, a Purdue professor of industrial and physical pharmacy.

In addition to collaborating with prominent industry members, LyoHUB roadmap development will include researchers with Purdue’s Department of Industrial and Physical Pharmacy, University of Connecticut, and University of Minnesota.

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