The Medical Center has opened the doors on a new facility that will enable researchers to create, study, and, ultimately, use stem cells and their offspring in early phase experimental human therapies. The Upstate Stem Cell cGMP Facility—which will be used by academic and private-sector scientists from across the state—was created with $3.5 million in support from the Empire State Stem Cell Board.
“One of the critical barriers to moving cell-based therapies into clinical trials is the requirement that these cells be manufactured in a facility that meets strict federal requirements,” says Steve Dewhurst, Dean’s Professor and chair of the Department of Microbiology and Immunology and principal investigator for the state grant. “Without this resource, much of this science remains stuck in the lab.”
The facility is located in the DelMonte Neuromedicine Research Institute. cGMP stands for “current good manufacturing practice,” a term that means that the facility, its operation, and the people that work in it meet federal manufacturing guidelines necessary to ensure that biological materials produced there are suitable for human clinical trials.
“Our scientists have made tremendous progress over the last several years unlocking the potential of stem cells to treat a long list of diseases,” says Bradford Berk, Medical Center CEO and a member of the Empire State Stem Cell Board. “I anticipa te that this new facility will accelerate research across that state and make Rochester a center for the development of new cell-based therapies.”
Projects under way at the 3,600-square-foot facility include: