Cornell University
NHLBI Programs of Excellence in Gene Therapy Clinical Grade Adenovirus Vector Production Core at Cornell University (PEGT-CGAD)
The NHLBI Programs of Excellence in Gene Therapy Clinical Grade Adenovirus Vector Production Core at Cornell University (PEGT-CGAD) has been established as one of six PEGT national service cores to provide eligible NHLBI-supported investigators with the following services, free of charge. The Core, in collaboration with investigators (users) will manufacture clinical grade adenovirus vectors in one of the facility's three production suites using validated methods and existing documentation, including standard operating procedures and batch records. A master cell bank is available for the production of first generation vectors with the available option for producing a certified cell bank for other adenoviruses, as needed. Documentation in support of regulatory submission will be made available for the manufacture and control of clinical grade vectors. This includes the reference to a facility Drug Master File, Type II. A full array of quality control procedures are available at the Core or through the use of outside contractors that have been audited by the Core staff.

As it is expected that the demand for NHLBI PEGT-CGAD services may exceed the resources of this core, applications for services will be peer-reviewed by an External Scientific Panel, and prioritized by the PEGT Steering Committee. Final funding decisions will be made by NHLBI staff, based on consideration of the peer-review, prioritization, and overall program balance. Evaluation criteria will include quality of preliminary data; evidence for biological and clinical relevance, protocol design (including feasibility, rationale, and statistical analysis), and overall scientific merit.

To apply for services, please download the application form (requires Adobe Acrobat reader) and fax to 212-746-8824. An online form will soon be available. Applications will be reviewed on a rolling basis.

For questions about services offered by the NHLBI PEGT Clinical Grade Adenovirus Vector Production Core, please contact Stephen Kaminsky by e-mail at GeneRX@med.cornell.edu, or by mail at the Belfer Gene Therapy Core Facility, Weill Medical College of Cornell University, Box 228, 1300 York Avenue, New York NY 10021.

University of Pittsburgh
The NHLBI Programs of Excellence in Gene Therapy Clinical Vector Production Core at the University of Pittsburgh has been established as a clinical viral vector and clinical non-viral vector system core production facility. The core, in collaboration with principal investigators, the FDA, and other Federal regulatory agencies will produce, store, evaluate, and distribute to eligible NHLBI investigators clinical grade viral and non-viral gene transfer vectors for use in clinical gene therapy trials as well as pre-clinical toxicology studies. As such, the core will maintain and provide master cell banks (MCB) and working cell banks (WCB) of viral packaging cell lines, MCB of bacteria containing plasmids, master seed stocks of recombinant Adenoviral vectors, and the appropriate regulatory documentation to support the use of these products. 

During the first year of operation, the Clinical Grade Vector Production Cores will develop and provide lots of clinical grade retroviral and adenoviral vectors to investigators for use in both in vivo and ex vivo gene transfer applications. The core will also work to provide technical assistance and training to individuals as well as provide clinically relevant strategies to optimize gene transfer into relevant target cells or target tissues. Sometime during the second year of operation and thereafter, the core will produce and make available to NHLBI investigators lots of clinical grade recombinant Herpesvirus and Adeno-Associated Viral vectors as well as stocks of purified plasmid DNA for non-viral gene transfer applications. 

For questions about services offered by the NHLBI PEGT Clinical Grade Vector Production Core, please mail John A. Barranger, M.D., Ph.D at the Human Gene Therapy Applications Laboratory, University of Pittsburgh, 200 Lothrop St., 1605E Biomedical Science Tower, Pittsburgh PA 15261 or contact him via E-mail at: JBARRANG@HELIX.HGEN.PITT.EDU