The Cyclotron Facility is contained within the Mallinckrodt Institute of Radiology. It contains two laboratories, a Good Manufacturing Practices (GMP) Facility, and a Radionuclide Production Laboratory (RPL) located in three buildings. The main activities of the Cyclotron Facility are to:
- Produce PET radiopharmaceuticals for clinical and clinical research use
- Produce Cu-64, Zr-89, Y-86 and Br-76 for research use and distribution across the United States and Canada
- Develop new PET radionuclides and production platforms for the translation of new PET radiopharmaceuticals for human use production.
The Cyclotron Facility has a 19 MeV variable energy Advanced Cyclotron Systems (ACS) cyclotron, 11 MeV Siemens RDS Eclipse, 16 MeV Japan Steel Works JSW168 and a Cyclotron Corporation CS-15. The GMP facility is used for the production of all human-use PET drugs which are produced under FDA’s Code of Federal Regulations (CFR) Part 212 for clinical use, or under the United States Pharmacopeia Chapter <823> for clinical research. It is fully equipped with 19 Becquerel Sievert (BqSv) hot cells, 2 dispensing hot cells and a Laminar Flow Hotcell. The GMP facility is licensed as an FDA Manufacturer for the production of Abbreviated New Drugs (ANDAs), FDG and N-13 Ammonia, and is licensed as WUSTL PET Nuclear Pharmacy under the State of Missouri Board of Pharmacy. The RPL has 4 BqSv hot cells for target processing. It has a special configuration including a double stack hot cell (DSC-100), large dispensing hot cell with tongs (LDHT-100) and an a large single hot cell (LSHC-100) enabling the automatic processing and dispensing of Cu-64, Zr-89, Y-86, Br-76 and other isotopes. The processing automation was developed at Washington University with the dispensing system being developed by BqSv according to Washington University’s specifications.
The facility houses 12 automated synthesis modules for the routine and research production of F-18, C-11 and N-13 labeled radiopharmaceuticals, and for production of Cu-64 and Zr-89. Quality Control and reagent laboratories support the operation of the GMP and the RPL. Analytic equipment for quality control analysis includes radio-TLC scanners, HPLCs with various mass and radio-detectors and GC systems. The associated Radiochemistry Imaging Laboratories (RCIL) have organic chemistry laboratories where precursors and non-radioactive standards can be developed and synthesized for translational radiotracers. The Clinical Center for Imaging Research (CCIR) facility is linked directly to the cyclotron facility by a pneumatic tube system for purposes of immediate unit-dose delivery of radiopharmaceuticals. These facilities provide radiopharmaceuticals for researchers from multiple departments as well as for commercial partners (see table).