ANSTO’s National Research Cyclotron Facility in Camperdown NSW has received a licence from the Therapeutics Goods Administration (TGA) to manufacture radiopharmaceuticals incorporating fluorine-18 (F-18) for Phase II and Phase III clinical trials.
“The Good Manufacturing Practice (GMP) laboratory at Camperdown has demonstrated that it meets the TGA’s rigorous safety and quality control standards for certification to produce F-18 radiopharmaceuticals,” said Dr John Bennett, Leader, Biosciences.
“This is good news for the medical research community and the pharmaceutical industry, who can now approach us to supply radiopharmaceuticals for clinical trials,” said Bennett.
“This development builds on ANSTO’s broader strengths in the commercial production of radioisotopes and radiopharmaceuticals.”
F-18-based radiotracers produced at the cyclotron will now be available for studies that evaluate the efficacy of medical interventions, including the testing of new pharmaceuticals. Phase II and III clinical trials involve testing on several hundred to several thousand people. Phase III trials are the step prior to a new intervention being approved for release for routine clinical use.
Mark Calvi, Quality Assurance Manager at the National
Research Cyclotron facility played a key role in
acquiring the TGA licence
When combined with specific marker molecules, F-18 is the most widely used radioisotope in clinical imaging. Positron emission tomography (PET) and single photon emission computed tomography (SPECT) scans, which use F-18 based radiopharmaceuticals, provide important information for the clinician.
Pharmaceuticals can be selected to determine the location and stage of diseased tissue, demonstrate the effectiveness of treatment, and contribute to an understanding of the physiological and metabolic processes involved.
The TGA’s GMP certification is a rigorous process, which guarantees safe, sterile, effective and high-quality pharmaceuticals, with extensive supporting documentation.
Certification also covers the design and maintenance of the facilities and equipment used to produce the goods, as well as manufacturing, storage and distribution processes.
The National Research Cyclotron Facility is an 18MeV cyclotron particle accelerator that produces radioisotopes and a wide range of radiotracers for research and both pre-clinical and clinical trials.
Being based in Camperdown, Sydney, it is accessible to scientists, researchers and students from across Australia. The Facility forms part of the National Imaging Facility and a significant component of Australia’s substantial national research infrastructure.