SA radiation applications specialist to expand radioisotopes range

13th June 2014

By: Keith Campbell

Creamer Media Senior Deputy Editor

  

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South African radiation applications business NTP Radioisotopes (NTP), a wholly owned subsidiary of the South African Nuclear Energy Corporation (better known as Necsa), will soon expand the range of radioisotopes it provides to the local and international medical communities, when it starts manufacturing Lutetium-177 no carried added (Lu-177 nca). The South African company has bought the licence to do so from German group ITG (which is based in Garching, site of the modern FRM-2 nuclear reactor).

NTP’s various medical products are marketed in Africa by its wholly owned specialist marketing and sales subsidiary, AEC Amersham. NTP itself will be responsible for export sales to all countries outside Africa and for which it has territorial marketing exclusivity.

“NTP is busy building a new production plant at Pelindaba to do this [manufacture Lu-177 nca],” reports AEC Amersham MD Wayne Flowers. “ITG have licensed the technology to NTP so that they can manufacture radiochemical (radioactive chemical compound) Lu-177 nca using Necsa’s [SAFARI-1 research] reactor and a dedicated processing plant. Going forward, we can sell the product to our traditional nuclear medicine customer base in South Africa. Lu-177 nca is a relatively short-lived isotope, making global export difficult, but shipments to South America and especially Brazil would be possible. Strategies to achieve significant export sales are well advanced, ahead of the scheduled commissioning of the production facility by NTP in June.”

Currently imported from Germany, Lu-177 nca has a half-life of only 6.7 days. Half-life is the length of time taken for the radioactive material to decay to half of its original radioactivity level. The ten to 12 hour flight from Europe, plus the handling times before and after the flight, appreciably cut into the life span of the material. Local production will increase the supply of the radioisotope available to the local nuclear medicine community, increase efficiency of its use and ensure that a greater number of patients benefit from its use.

Lu-177 nca therapy has had a dramatic impact on the treatment of neuroendocrine tumours (NETs) around the world, including in South Africa. NETS are neoplasms – abnormal masses of tissue created when cells divide more than they should or do not die when they should; they can be benign or malignant (cancer) – that arise from the cells of the endocrine and nervous systems. The tumours are treated intravenously with a peptide (a chemical compound containing two or more amino acids) linked to a radioisotope. In the case of a Dotatate peptide (a Dotatate is a chemical substance) linked to Lu-177, this is a highly targetted and effective therapy with minimal side effects.

The Lu-177 nca radioisotope, by itself, is not used in nuclear medicine. It is (as noted above) a radiochemical that forms the basis for the radiopharmaceutical that is actually used to treat patients. A radiochemical is turned into a radiopharmaceutical by linking it to peptides or other organ specific agents.

Tumour-specific radiopharmaceuticals can now be made. “This applies to both diagnosis using nuclear imaging technologies and treatment,” explains Flowers. “This [linking] process is called labelling. Currently, we import the Lu-177 and do the labelling here. “When we start local production, we’ll still do the labelling, but if we get permission to export to Brazil and elsewhere in South America, we would export the Lu-177 radiochemical and they would do the labelling there.”

Radiopharmaceuticals, in general, are used for imaging, treatment and follow-up (to see how effective the treatment was). NTP has pioneered and promoted such an integrated nuclear medicine approach in South Africa.

Another example of the group’s support for the local nuclear medicine community is the help it has given the public-sector Tygerberg Hospital to acquire a positron emission tomography (PET) camera. This is located at the Western Cape PET/CT Academic centre at the hospital and is supplied with the necessary doses of the fluorodeoxyglucose (FDG) radiopharmaceutical every day by the NTP group.

FDG is produced using another radioisotope manufactured by the company – Fluorine-18 (F-18). This is not manufactured with the SAFARI-1 reactor but by two small cyclotrons, one at NTP’s main site in the Necsa complex at Pelindaba, west of Pretoria, and the other at Faure, near Cape Town (located on the same site as the country’s only scientific research cyclotron, operated by the iThemba Laboratory for Accelerator Based Sciences). “This is a very important isotope used for diagnosing cancer and allowing for improved management of the disease,” highlights Flowers. “We produce the only registered FDG in South Africa for use at the various PET imaging centres. Its has a half-life of only 110 minutes. That’s why we manufacture it in Cape Town as well as at Pelindaba, to serve PET centres in both areas.”

NTP is particularly well known around the world for its production of molybdenum-99, which was its original product and which remains a very important one, with the company now holding about 20% to 25% of the world market. The other radioisotopes it produces are iodine-131, iridium-192 and caesium-137. In addition to nuclear medicine, the market sectors it serves are nondestructive testing and process control.

“NTP’s business is radiation,” affirms company MD Don Robertson. “We’re focused on all business opportunities related to radiation. “We have a R1-billion turnover and are profitable. We employ more than 270 at Pelindaba but our total workforce, including in our subsidiaries, is about 500.”

Edited by Martin Zhuwakinyu
Creamer Media Senior Deputy Editor

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