Gluscan® F-18 FDG
Gluscan ® FDG is used for reliable and accurate diagnostic imaging.
NTP Radioisotopes’ on-site FDG (F-18 fluorodeoxyglucose) production facility comprises a 16MeV GE PetTrace cyclotron and integrated radiopharmaceutical production, QC, dispensing and dispatch systems. The facility is located at Pelindaba, the large campus of the South African Nuclear Energy Corporation (Necsa), some 35 km west of Pretoria, South Africa and was commissioned on 1 September 2005. The facility produces radiopharmaceutical grade Gluscan® FDG for use in PET (positron emission tomography) and PET-CT medical imaging centres within a 3-4 hour total transport radius of the facility.
In order that PET imaging centres more distant from Pelindaba can benefit from approved Gluscan® FDG formulation, an agreement was entered into with iThemba LABS, operators of a 200 MeV cyclotron and associated facilities near Cape Town. In terms of this contract iThemba, using identical processing equipment to our facilities, makes FDG fully in conformance with Gluscan® protocols while NTP Radioisotopes is responsible for the effective commercial supply of all Gluscan® FDG doses to imaging centres throughout the country, regardless of where they are produced. Gluscan® users are thereby assured of cost-effective and reliable supplies of FDG wherever they are located in the country.
Gluscan® FDG Production and Application Cycle
FDG is used for diagnostic imaging, most commonly for the reliable and accurate diagnosis and staging of cancers as well as for monitoring and assessing the impact of therapeutic interventions. Increasingly, the scope of the diagnostic procedures performed using FDG is being extended to allow for the accurate diagnosis of a range of cardiac and neurological disorders. The company has plans to produce, in the medium- and longer-term, certain short-lived isotopes for cardiac and other PET-CT imaging procedures and to participate in pharmaceutical development and collaborative research projects.
Benefits for FDG Users
Gluscan® FDG produced at NTP facilities has a 12-hour shelf life and fully conforms to the requirements of the European Pharmacopoeia (Ph Eur).
The agreement with iThemba LABS provides users with a high degree of certainty of supply of the same quality product to which they have become accustomed. Managed by a first-class team trained in Europe and with a considerable depth of isotope and radiopharmaceutical production experience, NTP manufactures FDG of unmatched quality, having invested in QC equipment, training and procedures that exceed the most stringent regulatory requirements and reliability of supply.