The PET Cyclotron Radiochemistry Laboratory of the Huntsman Cancer Institute is located on the A level of the Huntsman Cancer Institute Building. The facility is 4,330 square feet and includes offices, clean storage, research laboratory, quality control laboratory, synthesis lab, a clean room, shipping room, electronics room, tank room and cyclotron room. The lab became operational in November 2002 and is GMP compliant.
The GE PETrace 800 Series Cyclotron is a negative ion accelerator in a self-shielded configuration.
- 16.5 MeV protons at 100 µA
- Dual target simultaneous irradiation
- Proton or deuteron particles
Six target configurations:
- F- High yield niobium targets (2), Dual beam with yields of 10.5 Ci in 120 min
- F2 target
- O-15 target
- N-13 target
- C-11 target
Radiochemistry Production Lab
The radiochemistry production lab facilitates the routine production of radiopharmaceuticals safely manufacturing a wide variety of PET radiopharmaceuticals. The lab contains 8 lead shields (mini-cells) manufactured by Jaltech which house a selection of different synthesis modules for radiochemistry. The lab is also equipped with a large shielded Capintec module (Hot-cell) with remote manipulators for manual processing of high amounts of radioactive materials for clinical and research applications.
Several synthesis modules are available which allow for a wide variety of radiopharmaceuticals to be produced in the lab and are listed below. The lab is also connected to an ISO 7 clean room equipped with ISO 5 rated laminar flow hood and Capintec Hot Cell Isolator for sterile processing and dispensing.
GE FASTlab Multi-Tracer Platform
The GE FASTlab Multi-tracer Platform is used for routine production of 18F-Fludeoxyglucose (FDG) and 18F-Sodium Fluoride (NaF). Several other research tracer cassettes are also available from GE Healthcare.
FX N TRACERLab
The FX N TracerLab research module is completely open interface module. It can be configured for almost any nucleophilic 18F-Fluorine synthetic method. It also includes a preparative HPLC system for purification of the desired radiochemical product.
FX C pro TRACERlab
The TRACERlab FX C Pro is an automated system for easy and efficient production of 11C based tracers. It provides [11C]-methyl iodide or [11C]-methyl triflate production and methylation of PET tracers in one module. It also has built-in HPLC purification.
Reform-Plus with Molecular Sieves Oven
The ReFORM-Plus uses various types of reformulation: SPE reformulation, fraction collection, and evaporation are standard reformulation methods. Users can customize these methods or create new ones to maximize the reformulation process. The ReFORM-Plus can also be used as a stand-alone module for simple methods using a disposable cassette. The Molecular Sieves Oven allows for [11C]-CO2 labeling of radiopharmaceuticals in conjunction with the ReFORM-Plus.
GE O-15 Water Module
The O15 water module is used in the synthesis of [15O]-Water for investigational studies.
Quality Control Lab
The quality control lab contains cGMP validated equipment for the routine testing of radiopharmaceuticals manufactured in the cyclotron lab. Some of the major equipment includes:
- Waters Alliance HPLC system with PDA detector
- Waters 600E Controller HPLC system
- Bioscan HPLC radioactivity detectors
- Agilent 6850 GC
- Agilent 6890N GC
- SRI8610 GC system
- Charles Rivers Portable Endosafe®-PTS
- Multi-channel γ-ray Analyzer (Canberra)
- EZ-Scan TLC scanner (Carroll & Ramsey Assoc.)
- Dionex IC1600 System
- Advance MicroOsmometer 3300 (Advanced Systems)
- Analytical Balances
- pH Meters
Since 2012 the manufacturing of PET radiopharmaceuticals must be performed under cGMP regulations set forth in 21 CFR 212. The cyclotron radiochemistry lab has since made several remodels and upgrades in order to comply with these regulations. The controls of materials, validated processes and quality assurance program have all been established. In 2012, the lab submitted two ANDAs, one for the manufacture of 18F-Fludeoxyglucose (18F-FDG) and 18F-Sodium Fluoride (18F-NaF). All other radiopharmaceuticals produced in the lab under approved INDs according to FDA guidances and according to USP <823>.