Experts Set a 10-Year Roadmap for Optimizing Lyophilization

The Advanced Lyophilization Technology Hub (LyoHUB), a consortium of experts at Purdue University, has published a 10-year road map to identify improvements that are needed to freeze drying, or lyophilization, a mainstay of drug manufacturing that has seen little fundamental change since it was introduced to the pharmaceutical industry in the 1940s. The roadmap represents the collective knowledge of more than 100 individuals from industry, academia, and government laboratories who focus on lyophilization, including Michael Pikal, professor of pharmaceutics at the University of Connecticut, and Steve Nail, senior research scientist at Baxter Biopharma Solutions.

“Ultimately, we’d like to help bring about high-quality, lower cost, more readily available pharmaceuticals and food products that are made with lyophilization or related new technologies,” said Elizabeth Top, a professor at Purdue’s Department of Industrial and Physical Pharmacy.

Introduced at the International Society of Lyophilization conference in Cambridge, Mass, on Sep. 12, 2017, the road map identifies the key factors driving change, gaps in technology that require research solutions, industry needs, educational roles and regulatory issues that will help shape the field over the next decade.

Improvement is most urgently needed in products, process, and equipment, said Professor Pikal.  Energy efficiency, well under 5% in the typical production-scale lyophilizer, could also be improved, noted Alina Alexeenko, professor at Purdue’s School of Aeronautics and Astronautics.

One of the goals of new research is developing a continuous lyophilizer, which would lead to dramatic improvements in efficiency. “At the same time, we want to explore other kinds of drying technologies that might be quicker, less expensive, and still preserve the integrity of the products,” Topp said.

LyoHUB members plan to publish best lyophilization practices regularly and to conduct research and training programs, tailored to staffers who range from plant operators to scientists with PhDs. The group also plans to develop biotech processing education programs at universities to help industry fill a need for skilled workers.

LyoHUB was formed in 2014. The center has been funded by the National Institute of Standards and Technology through a $453,623 planning grant from its Advanced Manufacturing Technology Consortia, or AMTech, program.

In 2016, Purdue launched the LyoHUB Lyophilization Technology Demonstration Facility for research and development and pilot demonstration projects. Because companies have access to this facility they can develop technological innovations in lyophilization faster and more cooperatively. The facility has already brought together researchers from fields as distinct as pharmaceutical science, electrical engineering, materials science and engineering, and biomedical engineering, said Topp.

LyoHUB is also supported by industrial membership fees and a grant from Indiana’s Next Generation Manufacturing Competitiveness Center.

Source: Purdue University