Radionuclides – Background
Since the late 1980’s, the Radionuclide Production Department has been known for supplying both the national and international markets with high quality accelerator based radiopharmaceuticals / radionuclides. This included the supply of short-lived SPECT radiopharmaceuticals such as 123I-related products and 67Ga to its over 25 nuclear medicine departments in South Africa. In 2006, our first commercial PET radiopharmaceutical, 18F-FDG, and in 2008 our first commercial 68Ge/68Ga generator was produced.
All iThemba LABS radiopharmaceuticals are mainly used for diagnostic purposes and/or therapeutic purposes in nuclear medicine. It is for this reason that iThemba LABS radiopharmaceuticals are produced according to the Medicines and Related Substances Act (Act 101 of 1965, Section 22C, Regulation 19) as administered by the Medicines Control Council of the Department of Health of South Africa and it is therefore obligated to prescribe to the current Good Manufacturing Practice (cGMP) principles.
In addition, as a producer of radiopharmaceuticals, iThemba LABS is also registered as a Manufacturing Pharmacy as per the requirements of the South African Pharmacy Council.
Since the late 1990’s, the supply of long-lived radionuclides focused mainly around the export of 22Na and 22Na positron sources and unprocessed radionuclides (irradiated targets) such as 73As, 68Ge and 82Sr to it’s over 60 clients worldwide.
Today, we still remain the only supplier in the world of 22Na positron sources.
Supply and / or distribution agreements with reputable international companies / agencies such as Nordion (Canada), Department of Energy (USA), IDB-Holland, QT Instruments and others have ensured sustained annual income for iThemba LABS.
Although, the primary function of the Department is to ensure we produce radiopharmaceuticals for the benefit of the local South African Nuclear Medicine Community and secondarily produce long-lived radionuclides for the export market to aid cost recovery, equally important is a) the research and development program and b) the training and development program of external students and self development of its own personnel. Over the years the vibrant research and development program has always realised quality publications in peer-reviewed journals. The Department’s is actively involved in S & T’s bilateral agreement, IAEA iniatives, NTEMBI, etc.