University of Rochester Stem Cell cGMP Core Facility

Our mission is to help researchers from our Institution, outside academic institutions or companies to develop and produce cell based therapeutic products to be tested in Phase1 or Phase 2 clinical trials.

Our facility has extensive experience working with stem cells (adult, ESC, iPSC, MSC) and differentiation protocols, as well as production capabilities for immune cells (T-cells, Dendritic and Lymphocytes) for autologous or allogeneic transplants. We are versatile in cell culture, expansion and scale-up (adherent and/or suspension) either using cell factories or wave bioreactors. We can also produce gene therapy vectors in an FDA compliant negative pressure ISO Class 6 environment. In each program that we have worked so far, either in process development or GMP production, we have generated Master and Working cell banks. We can also offer Monoclonal antibody and recombinant protein production, using either bacterial or mammalian cells as overexpression systems. Please check our website to learn more about us:

Sharyl Zaccaglino
Director, Research Quality and Compliance