Overview
The Vector Production Facility (VPF) is a controlled access Biosafety Level 2 (BL2) cleanroom for the manufacturing of viral vectors and other products for Phase I & II clinical trials in compliance with FDA current Good Manufacturing Practice (cGMP) regulations (21 CFR Parts 210 & 211).
The approximately 1400 square foot GMP cleanroom facility is divided into functional areas with cleanroom classifications appropriate to the activities performed in each area. Both Gown and De-Gown rooms are non-classified cleanrooms, the Common Area and the two Storage Areas are Class 100,000 (ISO Class 8) environments, and the two Tissue Culture Labs (TCLs) and TCL Airlocks are Class 10,000 (ISO Class 7) environments. The Compressed Gasses Room, the Autoclave Room, and the Testing Lab are non-cleanroom areas that support the VPF.
When in cleanroom status and during clinical production, personnel entering the cleanroom are required to wear personal protective equipment, including coveralls, hair covers, shoe covers and gloves. Personnel entering the TCLs don second stage gowning for added protection of the clinical product. All open-container processing is performed inside Class 100 (ISO Class 5) Biological Safety Cabinets in the TCLs. The air inside the cleanroom is HEPA-filtered, and manufacturing conditions have been further optimized by a system of differential air pressures between individual rooms. All rooms and surfaces are regularly maintained and monitored for viable and non-viable contamination. Critical laboratory equipment is connected to a central alarm system and is validated to function properly prior to use.
The VPF is located at Bio/Start on the third floor the Hoxworth Building and is operated and managed by personnel from the Division of Experimental Hematology and Cancer Biology of the Cincinnati Children's Research Foundation.
Contact Us
For further information regarding the Vector Production Facility (VPF), please contact Dr. Han van der Loo at 513-475-4093 (Ext. 1). For additional information about the Division of Experimental Hematology and Cancer Biology, please contact Dr. Yi Zheng at 513-636-0364. The Division of Experimental Hematology and Cancer Biology can be found in Room 7.205 of Location S (Research Foundation Building).
