The USC Molecular Imaging Center (MIC) is located at the Keck School of Medicine’s Clinical Sciences Center. MIC focuses on the translational needs of investigators, allowing in vivo imaging of disease processes and development of new molecular therapeutics and diagnostics from cell to human.
The mission of the Molecular Imaging Center is to promote the use of imaging to:
- Rapidly and effectively translate developments in cellular and molecular biology, chemistry, neurosciences, physics, computer sciences, engineering and instrumentation into improvements in research and patient care.
- Facilitate further advances in the understanding of the molecular basis of science and disease models.
- Train future investigators who will have the requisite multidisciplinary skills
to effectively lead the expansion of molecular imaging techniques.
MIC’s Preclinical Imaging Core is dedicated to research studies of biological specimens, as well as small and large animals for a variety of applications. The Core facility is staffed with trained machine operators and animal technologists. MIC faculty are active in developing novel methods of imaging to obtain new types of information, as well as in applying current methods to study a wide range of biomedical questions. The pre-clinical versions of PET, CT, MR, Optical and Ultrasound scanners in our facility provide information from studies in pre-clinical models, which can be directly translated to clinical settings. In addition to the structural and functional data provided by each instrument, supplemental data also can be acquired using autoradiography and biodistribution studies. Also, optical imaging studies provide gene reporter analysis using transgenic models or tumor cell lines with luciferase or fluorescence measurements of labeled molecule distribution using quantum dot nanotechnology.
CYCLOTRON/PET cGMP RADIOPHARMACY
There is an ever-increasing demand for new and more sophisticated imaging probes for experimental research and clinical applications, especially with the escalation of molecular medicine approaches to therapy design. The center just recently completed the installation of the state-of-the-art cyclotron/PET cGMP radiopharmacy.
A cyclotron is a particle-accelerating device that allows for the production of onsite radiopharmaceuticals for studies using Positron Emission Tomography (PET) scans. A PET scan is a whole-body imaging scan that allows doctors and researchers to view a patient’s internal organs at the cellular level. The availability of the cyclotron and cGMP radiopharmacy will provide USC investigators with these invaluable resources.
The primary mission of this resource is to provide expertise in the design, synthesis, and production of radioactive or stable agents for imaging of various disease and research applications and make such agents available to USC investigators. Our vision is for the USC MIC to have a comprehensive radiopharmacy and chemistry program focused on the development of new radiotracers and non-radioactive biological probes for use in interdisciplinary biomedical research and imaging.
The goals of the Cyclotron/Radiopharmacy facilities are to:
- Provide USC investigators with desired probes on a dependable basis for use in PET, micro-PET, and other procedures in proposed investigations.
- Provide expert advice to USC investigators regarding selection of existing imaging probes for use in research studies or for development of new agents.
- Investigate new synthetic procedures and devices designed to improve or obtain new access to radiotracers and other non-radioactive imaging probes through collaborative exchange with faculty from disciplines such as chemistry, engineering and physics.
- Identify new molecular targets for imaging by engaging expertise in fields, such as molecular biology and pharmacology.
- Create educational opportunities to cross-train molecular imaging scientists from a variety of disciplines on use of radiochemistry and other synthetic procedures for probe preparation.
- Promote utilization of molecular imaging probes in interdisciplinary research efforts.
Facility & Equipment
The facility contains all the equipment needed to support good manufacturing processes (GMP) radiopharmaceutical development and production for molecular imaging studies. Production of the PET radioisotopes will be accomplished by a state-of-the-art radiochemistry research facility with a high energy (16MeV) GE PETtrace cyclotron. Furthermore, the laboratory has new automated radiochemical processing modules, including a system to process metal targets for the production of copper isotopes that are integrated with the new cyclotron operating system.
The radiochemistry laboratory will adhere to current GMP standards as described in 21 CFR part 212, and USP Chapter 823. The facility houses designated hot cells for each processing module and laminar flow hot cells for sterile handling of the final product. The quality control laboratory has multiple analytical instruments, HPLCs, gas chromatographs, spectrometers, pyrogen testing system, etc., for final product analysis.
- In vitro and in vivo evaluation of molecular targets
- Probe validation with in vitro and in vivo models
- Small animal imaging: PET, SPECT, MR, Optical, Ultrasound, Photoacoustics and CT
Novel probe development:
- Custom synthesis of small molecules and peptides (precursors and reference standards)
- Peptide synthesis
- PET and SPECT isotopes
- Adaptation to automated synthesis units
- Separation and purification strategies
- Development of platform labeling technologies
Manufacturing and Quality
- Process development and validation
- Analytical and bioanalytical method development and validation
- Quality control & quality assurance audits
- Drug product formulation
- Stability testing
- cGMP production of PET imaging biomarkers
- Drug development plans and regulatory strategies
- Preparation and management of regulatory submissions
- Regulatory liaison
- Preparation of clinical trial documentation
- Management of clinical trial research