Experts Partner to Optimize Lyophilization

Purdue University researchers and industry experts have partnered to update the freeze-drying process known as lyophilization, according to a Jan. 18, 2018 university press release.

A consortium of researchers and members of various industries, including the pharmaceutical, food-processing, and equipment sectors, will join forces at the university’s Advanced Lyophilization Technology Hub (LyoHub) to modernize the freeze-drying process, which has not changed fundamentally in 70 years.

Lyophilization is used to stabilize products susceptible to physical and chemical degradation, and is often time-consuming, expensive, and has an energy efficiency of less than 5 percent, according to the university. The rise of biologics, which are heavily reliant on the lyophilization process, drives the need for an upgraded preservation approach.

“Our ultimate goal is to develop a new type of process that will make lyophilization obsolete,” said Elizabeth Topp, a professor at Purdue’s Department of Industrial and Physical Pharmacy who co-leads LyoHub with Alina Alexeenko, a professor of aeronautics and astronautics at the university, in the release. “I hope the conventional inefficient process will be supplanted by something that can be better controlled and is much more efficient in terms of time and energy.”

LyoHub is also working to improve each step in the lyophilization process, with researchers focusing on the development of sensors that are less bulky and to advance process analytical technology, according to Perdue.

In September 2017, LyoHub announced the publishing of a 10-year roadmap identifying crucial improvements to lyophilization. The group is also working to publish a set of best practices to promote scientifically-sound and industry-standard approaches for issues including equipment qualification, batch acceptance, process validation, and cleaning validation.

Additionally, the consortium aims to improve communication with regulatory agencies while developing industry standards.

“We have very high-tech products that depend on this very old-fashioned process. The question before LyoHub is: How do we advance this technology so we have a faster, more efficient way of getting stable, dried products on the pharmacy side?” Topp said in the release.

University researchers have filed patent applications related to lyophilization through the Purdue Office of Technology Commercialization.

Source: Purdue University