CINCINNATI CHILDREN'S HOSPITAL MEDICAL CENTER
• –––––– square feet of manufacturing space
• –––––– capacity for cell banking
• ____ research bays
• ____ available research team members
The Cincinnati Children's Hospital Medical Center Viral Vector Core at the Division of Experimental Hematology and Cancer Biology offers production of research-grade retroviral and lentiviral vectors, generation of stable producer lines, and non-GMP quality control testing including vector titer by functional assay FACS or PCR, mycoplasma, and sterility testing. The research Viral Vector Core has provided viral vector preps to institutions locally, nationally and internationally.
The Viral Vector Core has been listed as a shared resource of the Ohio State Comprehensive Cancer Center (OSUCCC)-Cincinnati Children's Cancer Consortium. Vector development is provided in collaboration with Dr. Axel Schambach at the Department of Experimental Hematology at the Hannover Medical School in Hannover, Germany.
The Vector Production Facility is a cleanroom facility that is fully compliant with FDA’s current Good Manufacturing Practices (cGMP) for the manufacturing of viral vectors in support of early phase clinical trials. The facility has been in operation since 2005.
The Aseptic Processing Laboratory Facility consists of approximately 1,600 square foot of controlled-access space that includes three (3) independent ISO Class 7 cleanroom suites equipped with biosafety cabinets for aseptic processing. Support areas include, a Gown and De-Gown room, a Materials Airlock, pre-and post-production corridors, and a support room for closed processing.
Services offered include pilot studies, development, optimization, scale-up and large-scale manufacturing of viral vector products. Products prepared in the past include cGMP-grade Master Cell Banks (MCB), gamma-Retroviral (gRV) vectors, Lentiviral Vectors (LV), Adeno-Associated Virus (AAV) vectors and Adenovirus (Ad). Custom services include certification testing, stability studies, purification, concentration and vialing as well as cryogenic storage of clinical products and validated shipping.
All critical facilities and equipment used in GMP manufacturing have been validated to meet Phase I/II drug product requirements and all instruments have been calibrated to NIST standards. Critical computer systems are compliant with 21 CFR Part 11 suitable for Phase I/II, Aseptic processes have been validated to meet the requirements set forth in the Guidance for Industry, Sterile Drug Products Produced by Aseptic processing and are compliant with 21 CFR Parts 210 and 211.
A Type V Master File (MF-BB) is on file with FDA/CBER. A letter of cross reference to the DMF is available upon request. VPF staff have experience in providing investigators support in development of relevant CMC (Chemistry Manufacturing and Control) sections for vector production for both INDs and IMPDs.