CQCI Radiochemistry - Resources

The PET cyclotron radiochemistry laboratory at Huntsman Cancer Institute (HCI) is located on the A level of the HCI Cancer Hospital. The 4,330-square-foot facility includes offices, clean storage, synthesis lab, quality control lab, clean room, shipping room, electronics room, tank room, and cyclotron room. The lab became operational in November 2002 and is GMP compliant.

Cyclotron

The GE PETrace 800 Series Cyclotron is a negative ion accelerator in a self-shielded configuration.

Specifications:

• 16.5 MeV protons at 130 µA
• Dual target simultaneous irradiation
• Proton or deuteron particles

Six target configurations:

• F- High yield niobium targets (2), Dual beam with yields of 16.0 Ci in 120 min
• O-15 target
• N-13 target
• C-11 target

Radiochemistry Production Lab

The radiochemistry production lab facilitates the routine production of radiopharmaceuticals. The lab contains 14 lead shields (mini-cells) manufactured by Jaltech and Radiation Shielding Inc. 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^TM Multi-Tracer Platform

The GE FASTlab^TM Multi-tracer Platform is used for routine production of 18F-Fludeoxyglucose (FDG), 18F-Sodium Fluoride (NaF), Axumin (Fluciclovine), and Vizamyl (Flutemetamol). Several other research tracer cassettes (FLT, FMISO, FES, etc...) are also available from GE Healthcare and other suppliers.

FX N TRACERlab and FX2 N TRACERlab

The FX N TRACERlab research module and next generation FX2 N TRACERlab are completely open interface module. It can be configured for almost any nucleophilic 18F-Fluorine synthetic method. The FX2 N TRACERlab contains dual reactors for two-step synthesis. 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.

Neptis Perform

The Neptis Perform module is an automated system or development of 18F-based tracers. It utilizes non-proprietary cassette components for simple design. It is also equipped with an HPLC system for semi-prep purification of tracers.

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 systems with PDA detectors and QDa detector
• Bioscan HPLC radioactivity detectors
• Agilent 6850 GC
• Agilent 7890 GC
• SRI8610 GC system
• Charles Rivers Portable Endosafe®-PTS
• Multi-channel γ-ray Analyzer (Canberra)
• EZ-Scan TLC scanner (Carroll & Ramsey Assoc.)
• Dionex^TM ICS-5000+ system with IC and ECD detectors
• Advance MicroOsmometer 3300 (Advanced Systems)
• Analytical Balances
• pH Meters
• Incubators

cGMP Production

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). A few years later, our lab became a contract manufacturer (CMO) for Axumin (18F-Fluciclovine) and Vizamyl (18F-Flutemetamol). All other radiopharmaceuticals produced in the lab are under approved INDs according to FDA regulation and guidances and according to USP <823>.