Overview

The Cincinnati Children’s Hospital Translational Core Laboratory (TCL) has been assisting investigators in translating innovative processes from bench to bedside since 2003 with a focus on manufacturing and testing for cell and gene therapy clinical trials.  The TCL is operated under controls that ensure compliance with current Good Manufacturing Practices (cGMP) and Good Tissue Practice (GTP) in support of early phase INDs.  Clinical manufacturing is done in state-of-the-art ISO Class 5, 7, and 8 clean environments in accordance with aseptic processing guidance and located on the 11th floor of CCHMC Research Building S.  Specifically we offer:
  • GMP Viral Vector Manufacturing (lentiviral and retroviral vectors)   
  • GMP/GTP Cell Processing (HSC and T-Cell)
  • GMP and CAP/CLIA Testing (Product Release and Patient follow-up)
  • Normal Donor Products
  • Research Viral Vectors (Lenti, Retro, AAV, and FV)

We recognize that every project is unique and our scientists and regulatory professional work closely with sponsors to identify and address technical and regulatory issues in a time and cost effective manner and expedite moving the project into active clinical trials.