Overview
This Aseptic Processing Laboratory is a fully compliant GMP facility used to develop, produce, and characterize sterile viral vector products and cell therapy products aseptically manufactured supporting Phase I and Phase II clinical trials. The Vector Production Facility is part of the Aseptic Processing Laboratory located within the Translational Cores Laboratories on the 11th floor of location S, Suite 400.
The facility consists of approximately 10,000 ft2 of controlled-access space. Facility design, process design, construction and operations have been set up to be compliant with current Good Manufacturing Practices (cGMP) for manufacture of aseptic clinical materials in support of early phase clinical trials. A Type V Drug Master File (DMF) has been submitted with the FDA/CBER that describes the details of the Vector Production Facility. A letter of cross reference to the DMF is available upon request.
Since initiation of cGMP operations in 2006, the Vector Production Facility has produced 12 cGMP products, including 6 retroviral vectors in support of the FDA's National Toxicology Program, two Adeno-associated vectors for the treatment of Parkinson's Disease and Epilepsy, and a safety-improved retroviral vector for the treatment of X-linked Severe Combined Immunodeficiency (SCID) for an international trial in London, Paris, Boston, Los Angeles and Cincinnati. New developments include the scale-up and cGMP production of lentiviral vectors, foamy virus vectors and oncolytic viruses based on Herpes Simplex Virus Type 1.
The facility is operated and managed by personnel from the Division of Experimental Hematology and Cancer Biology at the Cincinnati Children's Research Foundation.
For further information regarding the Translational Core Laboratories, please contact the Director, Translational Cores Dr. Punam Malik at 513-636-8588. For information on the Vector Production Facility (VPF), please contact Dr. Han van der Loo at 513-803-1066 or William Swaney at 513-803-1067. For additional information about the Division of Experimental Hematology and Cancer Biology, please contact the Divisdion Director Dr. Yi Zheng at 513-636-0364. The Division of Experimental Hematology and Cancer Biology Translational Cores can be found on the 7th floor of Location S (Research Foundation Building).
