DESCRIPTION (provided by applicant): The goal of this proposal is to install instrumentation for the production of non-commercially available radiolabeled imaging agents suitable for human use at the UC Davis Medical Center. UC Davis Medical Center is completing a Good Manufacturing Practice (GMP) laboratory at its main hospital campus in Sacramento. This GMP laboratory is a multi-use, 6 manufacturing suite, Class 10,000 facility. We propose to incorporate a commercial radiopharmaceutical synthesis system for the production of PET radiopharmaceuticals that has been designed complete with shielding enclosures allowing the production of radiopharmaceuticals to take place under full GMP compliance. The synthesis system allows the automated production of PET radiopharmaceuticals labeled with the positron emitter 18F via nucleophilic substitution reactions. The complete integrated system includes all necessary documentation for compliance with FDA GMP regulations as well as USP 797. As the NIH roadmap calls for an emphasis on translational research and has identified molecular imaging as a priority, UC Davis is proposing to build a bridge from functional and molecular imaging in animal models to humans. It is clear that currently a significant gap persists with regard to clinical and research molecular imaging in human subjects. This gap relates to the lack of access to non-commercially available molecular imaging radiopharmaceuticals for clinical and research human PET. Installation of this system into our state-of-the-art GMP facility will be the first step taken to facilitate bridging this gap. The system will be used to support clinical research ranging from cancer to cellular therapies, and will also be used to perform first in man studies of a range of new diagnostic and therapeutic agents under development by UC Davis faculty. The field of molecular imaging seeks to discover new approaches to imaging specific biologic targets and pathways in vivo, with the ultimate goal of providing patient-specific and molecularly-based diagnosis, prognosis and therapy. The faculty at UC Davis have expertise in the design of molecularly-targeted imaging agents that are currently under investigation in animal models with several leads at the translational stage. The proposed integrated system will allow us to synthesize both established and novel PET radiopharmaceuticals as diagnostic imaging agents complying with both FDA GMP as well as USP 797 for use in human imaging studies.
|Effective start/end date||4/1/08 → 3/31/10|
- National Institutes of Health: $497,275.00