Josh Wilhelm, MS

Cellular Manufacturing Core/R&D, Schulze Diabetes Institute

Josh Wilhelm

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Cellular Manufacturing Core/R&D, Schulze Diabetes Institute

Biomedical Engineering - University of Minnesota


Josh Wilhelm is an Associate Program Director in the Department of Surgery at the University of Minnesota. He is the Director of Islet Manufacturing and R&D at the Schulze Diabetes Institute, coordinating the islet isolation and research activities of the "Isolation Core". The Core processes pancreases from human, porcine, and primate donors to produce islet cell therapies for clinical and pre-clinical studies, and is one of the most experienced such groups in the world having completed 1000+ human, 1000+ porcine, and 100+ primate isolations. With an interest in the convergence of engineering and medicine, Josh obtained his M.S. in Biomedical Engineering from the University of Minnesota in 2004 and entered industry to explore the real-world application of biomaterials and cell, tissue, and gene therapies for Medtronic, Inc and several local medical device and biotechnology start-ups. Josh brought industry experience in cGMP manufacturing, process engineering, and quality systems to his role at SDI in 2008 as the lead supervisor for human clinical islet manufacturing. This work culminated in quality system improvements and the subsequent first product manufacturing and transplants for a Phase III clinical trial under IND with the FDA in the history of the University. After supervising and participating in nearly 500 islet isolations, Josh assumed the role of Director of the Isolation Core in 2014, where he manages both clinical and pre-clinical activities of the team and pursues research related to understanding and improving islet isolation yields and islet function. His particular research interest is in the application of commercial process engineering techniques like Design of Experiments (DOE), Statistical Process Control (SPC), and Quality by Design (QBD) to islet manufacturing, and use of high-throughput or multiplex technologies and equipment for islet functional characterization.