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Nuclear Medicine – Division: Radiopharmaceutical and Radiochemicals Manufacturing

Overview | Manufacture | Radioisotopes | Research & Development | Infrastructure | Staff

iThemba LABS, since the late 1980’s has been known for supplying both the national and international markets with high quality accelerator-based radiopharmaceuticals and radiochemicals. This includes the supply of short-lived SPECT radiopharmaceuticals such as 123I-related products (123I-solution, 123I-capsules and 123I-mIBG) to its over 40 nuclear medicine departments in South Africa’s private and public hospitals. In 2006, the first commercial PET radiopharmaceutical, 18F-FDG, and in 2008 the first commercial 68Ge/68Ga generator was produced by iThemba LABS.

iThemba LABS radiopharmaceuticals are mainly used for diagnostic purposes in nuclear medicine, and 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 (now under the auspices of the South Africa Health Products Regulatory Authority) and it prescribes to the current Good Manufacturing Practice (cGMP) principles. 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 radiochemicals focused mainly on the export of 22Na solution and ultra-high vacuum 22Na positron sources and unprocessed radiochemicals such as irradiated Rb metal targets (82Sr) to it’s over 80 clients worldwide. iThemba LABS remain the only supplier in the world of the ultra-high vacuum 22Na positron sources. Supply Agreements and Distribution Agreements with reputable international companies / agencies are in place to ensure a consistent market footprint and isotope revenue stream is maintained. Some of its partners include BWXT (formerly Nordion), DSD Pharma, IsoSolutions, QT Instruments and Syphen Technologies.

iThemba LABS produces more than 1400 consignments per annum to over 100 clients worldwide and the delivery of consignments correctly and punctually is maintained at a service delivery of above 98%. This contributes to the patient management of over 140 000 nuclear medicine patients of which 10 000 are local patients.

Although, the primary function of the Division is to ensure the manufacture of radiopharmaceuticals for the benefit of the local South African Nuclear Medicine Community and secondarily to produce long-lived radiochemicals 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.

The LRP of the manufacture programme is entirely based on the Accelerator Centre for Exotic Isotopes (ACE Isotopes) pillar of the South African Isotope Facility (SAIF) strategy of iThemba LABS which also encompasses the research and development programme that will focus on the development of new radiopharmaceuticals, in particular alpha emitting radiopharmaceuticals such as 211At and 225Ac and theranostic radiopharmaceutical pairs such as 43Sc and 47Sc for therapeutic nuclear medicine applications.