CQCIT Cyclotron / Radiochemistry
Huntsman Cancer Institute CQCIT operates two state-of-the-art cyclotron/radiochemistry laboratories to provide current good manufacturing practice (cGMP) quality positron emission tomography (PET) radiopharmaceuticals for both research and clinical needs.
The following radiochemistry resources and radiopharmaceuticals are available:
Radiochemistry Resources
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The original GE PETrace 890 Cyclotron is a negative ion accelerator in a self-shielded configuration that has been operational since 2003. This cyclotron has been upgraded and recently refurbished. A second cyclotron/radiochemistry laboratory was constructed in 2023, which includes a second GE PETtrace 890 Cyclotron with solid targets.
Specifications:
- 16.5 MeV protons at 160 µA
- Dual target simultaneous irradiation
- Proton or deuteron particles
- F- High yield shielded niobium targets (2), Dual beam with yields of up to 20 Ci in 120 min
- O-15, C-11. Ga-68 liquid targets
- Ga-68, Cu-64, Zr-89, solid targets
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CQCIT has two cGMP facilities that are licensed by the FDA (CFR Title 21 Part 212) for manufacturing of PET drugs (radiopharmaceuticals). Each lab contains multiple lead shielded hot cells, which house a selection of different synthesis modules for radiochemistry including multiple GEHC FASTlab 2, Trasis AllinOne, Neptis Ora, and TRACERlab FXC and FXN modules. Each manufacturing lab is also connected to an ISO 7 clean room equipped with ISO 5 rated laminar flow hood for dispensing hot cells.
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The quality control lab contains cGMP validated equipment for the routine testing of radiopharmaceuticals manufactured in the cyclotron lab. The major equipment includes the following:
- Waters Alliance HPLC systems with PDA detectors and QDa detector
- Bioscan HPLC radioactivity detectors
- Agilent 8890, 7890, and Intuvo GC
- Charles Rivers Portable Endosafe®-PTS
- High Purity Germanium Detector (Mirion)
- EZ-Scan TLC scanner (Carroll & Ramsey Assoc.)
- ThermoFisher DionexTM ICS-5000+ system with IC and ECD detectors
- Advance MicroOsmometer 3300 (Advanced Systems)
- Analytical Balances
- pH Meters
- Incubators
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The CQCIT facilities are licensed by the State of Utah as a Class C commercial pharmacy manufacturer. The radiopharmacy was first licensed by the State of Utah as a Class B pharmacy in September 2010.
An onsite PET radiopharmacy allows for the preparation of individual patient doses and distribution of PET radiopharmaceuticals to hospitals and clinics throughout the Intermountain region.
Radiopharmacy Staff
The radiopharmacy staff is composed of four Authorized Nuclear Pharmacists. They work in close partnership with the radiochemistry team to ensure regulatory and quality assurance of all FDA-approved radiopharmaceuticals, in accordance with the State Board of Pharmacy in the Division of Occupational and Professional Licensing (DOPL).
Radiopharmaceuticals
The following radiopharmaceuticals can be manufactured at CQCIT for clinical use under NDA/ANDA:
- FDG ([18F]2-deoxy-2-[18F]fluoro-D-glucose) for PET of imaging tumor glucose metabolism
- NaF ([18F]NaF) for PET imaging of bone mineralization
- Vizamyl ([18F]flutemetmaol for PET imaging of amyloid plaque
- Axumin ([18F]Fluciclovine) for PET imaging of amino acid transport in prostate cancer
- Pylarify [18F] DCFPyl) for PET imaging of PSMA expression in prostate cancer
The following radiopharmaceuticals can be manufactured at CQCIT for research purpose under IND help by CQCIT:
- FDG ([18F]2-deoxy-2-[18F]fluoro-D-glucose) for PET of imaging tumor glucose metabolism
- [18F]Flutemetamol for PET imaging of amyloid plaque
- [18F]Fluciclovine for PET imaging of amino acid transport
- FLT (([18F]Fluorothymidine) for PET imaging of cellular proliferation
- FMISO ([18F]Fluoromitronidazole) for PET imaging of hypoxia
- O15-Water ([150]H2O) for PET imaging of blood flow
- FES ([18F]Fluoroestrodial ) for PET imaging of Estrogen Receptor