Australian Precision Radiopharmaceutical Facility (APRF)
Accelerating precision medicine research
The Australian Precision Radiopharmaceutical Facility (APRF) will be established to position Australia as a leading Good Manufacturing Practice (GMP) compliant manufacturer of PET (positron emission tomography) radiopharmaceuticals interfacing with research, clinical and commercial users. The facility aims to enable expanded access to contemporary high-precision diagnostic and therapeutic treatments for cancer, cardiovascular disease, infectious diseases, neurological disorders, and other diseases.
In close proximity to the Monash Biomedical Imaging Facility, Victorian Heart Hospital and planned Victorian Health Innovation Centre in the Monash Innovation Precinct, the APRF will focus on the production of short half-life radioisotopes for the rapid translation of radiopharmaceuticals into phase I, II and III clinical trials and ultimately into routine clinical use.
Due to become operational by end of 2026, the APRF will house a 18-24 MeV energy cyclotron, providing local production and radiochemistry services for advanced diagnostics and therapeutics in one world-class facility.
Capabilities
The APRF cyclotron and related equipment will have the energy and capability to efficiently produce a range of PET radiohalogens and radiometals for research and limited commercial purposes. Cyclotron products include carbon-11, nitrogen-13, fluorine-18, copper-64, gallium-68, and zirconium-89. In addition, the APRF will possess the capability for radiopharmaceutical manufacture for clinical application. Products include the ubiquitous [18F]-fluorodeoxyglucose, established and novel radiopharmaceuticals.
Key facility equipment and capabilities will include:
- 18-24MeV cyclotron:
- Cyclotron irradiation and transfer system for streamlined and efficient production of PET radioisotopes;
- liquid targets for cyclotron produced nitrogen-13, fluorine-18, gallium-68, copper-64 and zirconium-89; and
- gas targets for carbon-11 production.
- Ancillary equipment:
- GMP-compliant manufacturing suite (including hot cell bank and grade A LAF’s),
- hot cell bank for research and development purposes,
- purification, dispensing, and synthesis modules,
- radiochemistry fume hoods for manual research and development procedures, and
- suite of radio-analytical equipment.
The APRF acknowledges the facilities and scientific and technical assistance of the National Imaging Facility, a National Collaborative Research Infrastructure Strategy (NCRIS) capability, at Monash Biomedical Imaging, Monash University. NIF is funding the purchase and operations of the APRF cyclotron via NCRIS and Victorian Government matching funds.
Timeline
The APRF is due to be launched for R&D work by the end of 2026 and GMP manufacturing by early 2027.
Contacts
Prof Christoph Hagemeyer
Interim Director, Monash Biomedical Imaging
Christoph.Hagemeyer@monash.edu
Kylie Reid
General Manager, Monash Biomedical Imaging
Maggie Auslebrook
Senior Radiochemist, Monash Biomedical Imaging