Lilly donates mobile lab for making sterile injectable drugs to Purdue’s Young Institute
WEST LAFAYETTE, Ind. — A mobile laboratory that Eli Lilly and Company used to compound the first FDA-authorized COVID vaccine will now offer students at Purdue University a valuable experience in compounding sterile injectable drugs. Lilly donated the lab, which is built into a 53-foot semitractor-trailer, to the William D. and Sherry L. Young Institute for the Advanced Manufacturing of Pharmaceuticals. It has been installed adjacent to the Young Institute’s 10,000-square-foot manufacturing facility, currently under construction in the Indiana Manufacturing Institute.
“The sterile mobile unit offers our students hands-on experience in the manufacture of sterile injectable drugs, which is a focus of the Young Institute,” said Elizabeth Topp, director of the Young Institute and a professor of industrial and molecular pharmaceutics in the College of Pharmacy and chemical engineering in the College of Engineering. “It’s an excellent complement to the manufacturing pipelines students will access in the larger racetrack facility, and we are grateful to Lilly for a donation that augments the opportunities we are able to offer our students.”
The Young Institute, part of Purdue’s Institutes and Centers at Discovery Park District, is in the process of renovating the high-bay manufacturing space in the Indiana Manufacturing Institute, with occupancy expected this winter. The renovation will create four manufacturing bays supported by an analytical laboratory and meeting and storage areas. Together with the mobile lab, commonly known as a sterile mobile unit (SMU), the new facility provides a home for the Young Institute’s pilot-scale manufacturing activities and will be used for training students and industry on biopharmaceutical manufacturing as part of Heartland Bioworks tech hub’s BioTrain program.
“The SMU will help us jump-start hands-on training on the fundamentals of aseptic manufacturing as part of the BioTrain program,” said Alina Alexeenko, co-director of the Young Institute and the principal investigator for the BioTrain program at Purdue.
Nathaniel Milton, a professor of practice in the Department of Industrial and Molecular Pharmaceutics, who aided in securing the donation, said the SMU is configured and equipped in a way that makes it possible to demonstrate aseptic processing of drug products that meet required standards of sterility and safety. As a cleanroom, the SMU is designed and equipped in a way that illustrates how personnel enter manufacturing process areas without contaminating the environment, reducing risk to the product.
“It has many of the environmental controls that you would have in a very large, traditional manufacturing facility, but as opposed to preparing tens of thousands of vials, the SMU can be used to prepare batches as small as 100 to 500 vials,” said Milton, who served with Lilly for nearly three decades. The SMU will provide hands-on teaching opportunities with equipment, process controls, material flow and aspects of sterile manufacturing like aseptic filling and sterile filtration. In a lab tour of the SMU, several of Milton’s undergraduate students recently aseptically manufactured lipid nanoparticles, building on their lab experience.
“The SMU mimics the manufacturing environment much more than our lab. In many ways, it is a scaled-down version of a commercial facility in terms of environmental controls, the flow of materials and how sterile solutions are prepared for drug products,” Milton said. “Students can learn proper gowning and gloving techniques, how people interact with the laminar flow hood, sterile filling of vials — the entire aseptic process simulation, which demonstrates how all your actions ensure a sterile drug product in a vial.”
The SMU was built by Germ Free and is described as a self-contained mobile cleanroom facility for clinical phase manufacturing, meeting Biosafety Level 3 standards established by the U.S. Department of Health and Human Services, and Current Good Manufacturing Practice regulations established by the U.S. Food and Drug Administration. Lilly deployed the SMU in May 2020 for clinical manufacturing of the first FDA-authorized monoclonal treatment to combat the COVID-19 virus.
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Writer/Media contact: Mary Martialay, mmartial@purdue.edu