Upstate Stem Cell cGMP Facility With funding support from the Empire State Stem Cell Board (NYSTEM) the University of Rochester Medical Center has constructed the Upstate Stem Cell cGMP Facility (USCGF), a fully validated facility designed for the manufacture of cell therapy products for early-phase clinical trials. 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 testing of final product Management of external CRO’s providing additional testing and services Quality control release of final product Our facility will provide training / educational opportunities Internships “Man-in-the-plant” opportunities Gmp process development & manufacturing Analytical methods development & qualification Quality Assurance / Quality Control Validation & environmental control Regulatory guidance Why cGMP? 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. View our brochure For more information, or to inquire about the availability of the GMP facility for research, please contact Michael J. Fiske.