Mallinckrodt Institute of Radiology operates a PET nuclear pharmacy and cyclotron facility for the routine production of radiopharmaceuticals and radiolabeled precursors used in research studies.

Core Description

Mallinckrodt Institute of Radiology operates a cyclotron facility and nuclear pharmacy for the routine production of radiopharmaceuticals, dispensing of radiopharmaceuticals and radiolabeling of precursors used in research studies.

The Cyclotron Facility is contained within the Mallinckrodt Institute of Radiology. It contains multiple laboratories, including Good Manufacturing Practices (GMP) Facilities, clean room environments for radiopharmaceutical dispensing under the practice of pharmacy and a Radionuclide Production Laboratory (RPL) located throughout three buildings.  The main activities of these facilities include:
a) routine production of radiopharmaceuticals for clinical and clinical research use, production of Cu-64, Zr-89, Br-76 and Br-77 for research use and distribution of radioactive materials across the United States and Canada
b) development of new PET radionuclides, production platforms, and translation of new radiopharmaceuticals from bench to bed-side

c) dispensing of radiopharmaceuticals, both diagnostic and therapeutic, for routine clinical use and for the use in clinical trials

 

The cyclotron facility has a 19 MeV TR-19/9 variable energy Advanced Cyclotron Systems Inc. (ACSI) cyclotron, 11 MeV Siemens RDS Eclipse, 16 MeV Japan Steel Works JSW168 and newly installed 16.5 MeV GE PETtrace 890. 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 two Laminar Flow Hotcells. 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, Br-76, Br-77 and other isotopes.  The processing automation used for these isotopes was developed at WashU.

The facility houses 35 automated synthesis modules for the routine and research production of F-18, C-11, Cu-64, Ga-68, Cu-67, Ac-225, O-15 and N-13 labeled radiopharmaceuticals, and for the production of Cu-64 and Zr-89 radiochemicals. Quality Control and reagent laboratories support the operation of the GMP and the RPL. Analytical equipment for quality control analysis includes radio-TLC scanners, HPLCs with various mass and radio-detectors and GC systems. The associated Precision Radiotheranostic Translation Center (PRTC) has organic chemistry laboratories where precursors and non-radioactive standards can be developed and synthesized for translational radiotracers.  The Clinical Center for Imaging Research (CCIR), BJH Center for Advanced Medicine (CAM) and the Gary C. Werths Building at Siteman Cancer Center are all linked directly to the cyclotron facility by a pneumatic tube system, for purposes of immediate unit-dose delivery of radiopharmaceuticals.

Access

Service available to All entities, including for-profit organizations.

Priority service for Specific groups, centers or departments – see Additional Information for details.

Additional information:

Only authorized individuals are allowed access to the cyclotron facility.​​

Services

  • The MIR Cyclotron Facility mission is to provide PET isotopes, radiochemicals, radio-tracers and radiopharmaceuticals to the research and medical community for use in research and clinical practice, meeting or exceeding user requirements, while safely and reliably insuring the highest level of quality reasonably achievable, following federal regulations and guidelines.

Equipment

  • 4 cyclotrons: GE PETtrace 890, TR-19/9, CTI RDS111 cyclotron, Japan Steel Works 16/8
  • 41 shielded workspaces
  • 8 laminar flow hot cell
  • a general chemistry hot cell with manipulator arms
  • 6 gas chromatographs
  • 8 HPLC systems
  • 2 IC systems
  • 2 radioTLC scanners
  • other equipment (i.e., automated chemistry systems) necessary for the production of PET radiopharmaceuticals

Pricing

Pricing is subject to core verification

Contact J.P LaVenture  at laventurej@wustl.edu or Greg Gaehle at gaehleg@wustl.edu for current pricing information.

AFFILIATIONS
Center for Clinical Imaging Research (CCIR)
Institute of Clinical and Translational Sciences (ICTS)
Small Animal Imaging Facility
Clinical PET Imaging