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The Cincinnati Children’s Hospital Translational Core Laboratory is a set of premier academic, non-profit core laboratories established in 2003 to ensure that innovations are efficiently translated from bench to bedside in a cost effective manner that meets quality assurance requirements. The Translational Core offers a one-stop shop to support gene and cell therapy clinical trials and includes laboratories for basic research, testing, scale-up, and clinical work. These core laboratories serve as a resource to investigators on and off campus.
The core has produced clinical products services in compliance with current Good Manufacturing Practices (cGMP) and Good Tissue Practice (GTP) in a state-of-the-art ISO Class 7 cleanrooms designed for aseptic processing. The cleanrooms provide a safe method for production of pharmaceutical grade biologics and innovative cellular based therapies suitable for use in Phase 1 and Phase 2 Clinical Trials. A new cleanroom facility was opened in 2009 to specifically meet the demanding needs of the scientific community.
The testing laboratory has been certified by the American College of Pathology and Clinical Laboratory Improvement Amendments (CAP/CLIA) and specializes in developing and conducting unique esoteric laboratory procedures for use in support of clinical trials as well as routine diagnostics.
We recognize that every project is unique and we work closely with Sponsors to transition non-clinical bench top protocol to a fully scalable reproducible GMP/GTP or CAP/CLIA compliant process. Our solution-oriented strategy enables our scientific team to identify and address technical issues in a time and cost effective manner. This approach expedites the translation of your process technology streamlining the move of your project from bench to clinic.
The Translational Core was founded with generous support from the Cincinnati Children's Research Foundation and the Charles H Dater Foundation. The Translational Core Laboratory is an active member of the Association of Academic Biologics Manufacturers (AABM) and provides leadership in education and regulatory compliance.