Monash University Cyclotron Facility
Accelerating precision medicine research
The Monash University Cyclotron Facility will be established to position Australia as a leading Good Manufacturing Practice (GMP) compliant manufacturer of 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.
The facility 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 the end of 2028, the facility 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
Cyclotron-Based Radioisotope Production
The facility will have the capability to produce a range of short- to medium-half-life positron emission tomography (PET) radioisotopes using an on-site medical cyclotron and associated targetry. The facility shall be capable of producing radioisotopes including fluorine-18, carbon-11, nitrogen-13, gallium-68, copper-64 and zirconium-89.
Externally Supplied Radioisotopes
The facility will have the capability to handle externally produced radioisotopes. This capability shall support both diagnostic and therapeutic applications. Radioisotopes may include, but are not limited to, diagnostic radionuclides such as technetium-99m, and iodine-123, and therapeutic radionuclides such as lutetium-177, actinium-225, and iodine-131, as required for research and clinical applications.
Manufacture of Finished Radiopharmaceutical Products
The facility shall have the capability to provide finished radiopharmaceutical products for human administration in accordance with applicable Good Manufacturing Practice (GMP) requirements. Products may be manufactured using either cyclotron-produced or externally sourced radioisotopes and shall support both routine clinical supply and investigational use. Finished products include, but are not limited to [18F]fluorodeoxyglucose, [68Ga]Ga-PSMA, and [68Ga]Ga-DOTATATE.
Acknowledgement
Monash University gratefully acknowledges funding contributions from the National Imaging Facility and the Victorian State Government through NCRIS and VHESIF in support of the establishment of this facility.
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