The goal of Advanced Lyophilization Technology Hub (LyoHUB) is to advance the science and technology of freeze-drying/lyophilization. LyoHUB’s members include companies in the pharmaceutical and food processing sectors, equipment manufacturers and university researchers, who combine their expertise and resources to accomplish the goal. Immediate objectives are: (i) to identify and disseminate Best Practices for lyophilization equipment performance, testing and validation and (ii) to conduct applied research to advance lyophilization processes and products.
Purdue University is scheduled to break ground for the William D. and Sherry L. Young Institute for Advanced Manufacturing of Pharmaceuticals “racetrack” facility and unveil a related technology roadmap Oct. 4. The event will be held from 3 to 6 p.m. at the Indiana Manufacturing Institute, 1105 Endeavour Drive, West Lafayette, Indiana. It will include remarks at 4 p.m., facility tours, and refreshments.
Remarks at 4:00 pm provided by:
When completed, the 10,000-square-foot, high-bay manufacturing space in the Indiana Manufacturing Institute research and training facility will contain four manufacturing areas, a shared analytical space, and loading/receiving and common area. Completion is expected in mid-2025. The Indiana Manufacturing Institute, in the Purdue Research Park, was part of a $250 million U.S. Department of Energy initiative to support President Barack Obama’s National Network for Manufacturing Innovation.
A “racetrack” facility, in this context, connotes features associated with racing, such as speed, steering and teamwork. Racing is a composite of speed and control, getting somewhere as fast as you can on a twisting and turning course in a tightly controlled manner — with a little bit of edginess and innovation. Via the facility’s research pace, the goal is to speed and optimize the pharmaceutical manufacturing process and make it more cost-effective, and the necessary corollary: deepen and accelerate development of a highly skilled next-generation workforce in biotechnology processing.
The event will feature the launch of the Lyo2040: Lyophilization and Freeze-Thaw Technology Roadmap for Pharma/Biotech Manufacturing. In April 2022, the National Institute for Standards and Technology (NIST) selected LyoHUB to expand on its 2017 technology roadmap to include novel freeze-drying, aseptic drying, freeze-thaw technologies, new product modalities like cell and gene therapies, nucleotides (building blocks of RNA), vaccines, therapeutics, and education/workforce development. In the past two years, LyoHUB has developed the new roadmap with a network of more than 100 industry, academic and government experts.
LyoHUB will be the first tenant of the racetrack facility, which will respond to needs identified. The strong presence in the racetrack facility will pave the way for adoption of new lyophilization technologies and provide valuable training in the lyophilization specialty. Lyophilization is a worthy manufacturing technology for the dynamic and innovative manufacturing domain, particularly with the surging demand for such lyophilized injectable products as mRNA vaccines – perishable products that must be preserved and rendered convenient for transport.
It’s fitting that the new facility groundbreaking and roadmap launch take place this year, as Purdue Engineering is celebrating its 150th anniversary, commemorating a century and a half of breakthrough achievements and educational excellence. The sesquicentennial honors Purdue’s profound impact on engineering research, innovation, and industry leadership.
Oct. 4 also is National Manufacturing Day, which aims to inspire the next generation of manufacturers and highlight the importance of the manufacturing sector in the U.S. economy. National Manufacturing Day features activities including plant tours, educational workshops, and presentations to showcase modern manufacturing technology and career opportunities. By connecting manufacturers with students, educators and community, National Manufacturing Day is designed to dispel common misconceptions about the industry and demonstrate its dynamic and innovative nature.
“We are excited to launch our new racetrack facility and technology roadmap,” said Elizabeth Topp, director of the Young Institute and professor in Purdue’s Department of Industrial and Molecular Pharmaceutics and the Davidson School of Chemical Engineering. “The route from molecule discovery to drug delivery is an arduous one, and our aim is to optimize one of the most critical processes along the way — lyophilization — to support the value chain of advanced pharmaceutical and biotechnology manufacturing in its mission to rapidly deliver life-changing therapeutics to the widest population in need.”
July 19, 2024
Residual gas analysis (RGA) can be used in pharmaceutical manufacturing to achieve a more comprehensive understanding of the freeze-drying process. RGA provides real-time insights into key variables, including leak detection and monitoring contaminants. For more on RGA in pharmaceutical lyophilization and experimental data from the LyoHUB demonstration facility, download the App Note prepared in partnership with innovative instrument provider, INFICON
https://lnkd.in/giy4KuVU
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