Welcome to the Upstate Stem Cell cGMP Facility

With support funding from the Empire State Stem Cell Board, the University of Rochester Medical Center has recently constructed and opened the Upstate Stem Cell cGMP Facility (USCGF) for the manufacture of stem cells and monoclonal antibody products for early-phase clinical trials. The USCGF is a key component of the University’s Stem Cell and Regenerative Medicine Institute and only one of a handful of academic cell-based cGMP (current Good Manufacturing Practice) facilities in the country It is a regional resource available to scientists in academia and industry throughout the country.

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The USCGF is designed as a multi-use cGMP manufacturing and testing facility with the goal of accelerating “first-in-man” early-phase clinical studies with the following capabilities:

  • Development of clinical-scale manufacturing
    processes
  • Development of analytical methods for
    product characterization and release
  • GMP manufacturing and in-process testing of
    clinical-grade materials
  • Quality control release of final product

The facility is open and available for contract manufacturing and testing services.

 

For more information, or to inquire about the availability of the GMP facility for research, please contact Michael J. Fiske