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), a fully validated facility designed for the manufacture of stem cells for early-phase clinical trials as well as research grade monoclonal antibody products. The USCGF is a key component of the University’s Stem Cell and Regenerative Medicine Institute and aims to serve as a regional resource for both academic and industrial scientists.
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
cGMP or Current Good Manufacturing Practices refers to the FDA Code of Federal Regulations which requires that products intended for human use are safe, pure, and effective.
GMP regulations and guidance provide for a “Quality Approach” to manufacturing and testing with the goal of eliminating or minimizing contamination, cross-contamination, mix-ups, and errors in order to protect human patients.
The FDA reviews submitted Investigative New Drug (IND) applications in order to determine whether the product to be used in the investigation has the identity, quality, purity, strength, and potency necessary to ensure the safety of the subjects in proposed Phase I studies.
For more information, or to inquire about the availability of the GMP facility for research, please contact Michael J. Fiske.