The worldwide nuclear medicine market in 2016 was worth more than $11-billion and is projected to be worth almost $20-billion by 2021. The South African Nuclear Energy Corporation (Necsa), through its use of its Safari-1 research reactor and its subsidiary company, NTP Radioisotopes, is one of only five sites in the world capable of producing one of the most important medical radio- isotopes, Molybdenum-99 (Mo-99), in commercial quantities. Necsa-NTP, based at Pelindaba, west of Pretoria, is now responsible for between 25% and 33% of global Mo-99 production.
“With regard to radioisotopes, we’re major world players – the number two exporter of medical radioisotopes in the world. We also produce industrial radioisotopes,” highlights Necsa board chairperson Dr Kelvin Kemm. “We export medical radioisotopes to some 60 countries every day. Studies show that someone is injected with our products every three seconds, and every three hours someone’s life is saved by our products. The global nuclear medicine market is already very big and is still just at the beginning of its growth curve, with regard to both therapeutics and diagnostics. And it is a profitable business. We undertake that patients can be injected with our products no later than 36 hours after it comes out of the reactor, even if the patient is on another continent.”
In most of the rest of Africa, however, nuclear medicine is still underdeveloped. The first African conference on nuclear medicine was held as recently as 2008, in Sudan. (By way of stark contrast, the British Institute of Radiology, then called The Röntgen Society, held its first conference, or Grand Inaugural Meeting, in 1897!) As of 2013, only 25 out of 54 African countries had radiotherapy facilities. However, this number has now grown; since then, Benin, Burkina Faso, Mali, Mauritania and Senegal have set up their first nuclear medicine centres. Mozambique’s first such centre should have recently started functioning. The International Atomic Energy Agency (IAEA) has designated South Africa as the nuclear medicine training country for Africa; the training is provided by the universities of Pretoria, Stellenbosch and the Witwatersrand.
“Radiation medicine and other nuclear techniques played [sic] very crucial roles in the management of non-communicable diseases and infectious diseases,” noted the IAEA in its ‘IAEA Technical Cooperation in Africa 2016’ report. “[R]adiology and nuclear medicine techniques are essential for early diagnosis and radiotherapy plays a crucial role in the treatment and palliation of cancer.”
Necsa estimates that setting up a basic nuclear medicine centre in other sub-Saharan Africa countries would cost between R10-million and R20-million. African countries are known to spend much more than that to send patients to other countries (often, to South Africa) for nuclear medical treatment. For example, Mozambique’s new radiotherapy and nuclear medicine unit, located at Maputo Central Hospital, cost some $15-million, the country’s media has reported. It has a staff of 12 physicians, physicists, radiotherapists and technicians. The hospital is already diagnosing 700 new cases of cancer each year, of whom only a few could be sent abroad for radiotherapy, and the new centre is expected to treat more than 300 patients annually.
“We’re looking at opening multiple nuclear medicine centres in other African countries, and we would supply them with radioisotopes and radiopharmaceuticals,” reports Kemm. The idea is to develop partnerships with other agencies, here and abroad, to provide the necessary funding. Possible partners could include the South African Department of International Relations and Cooperation, through its African Renaissance Fund, and the IAEA, as well as the countries in which these facilities would be established.
Naturally, there are limits to the opera- tional capacity of Safari-1, and these (and other) plans being developed by Necsa significantly exceed that capacity. A second reactor is required, and will be acquired. “The new reactor project is confirmed. It will go ahead,” he assures. “Late last year, government put this project into a category by itself and made it the sole responsibility of Necsa.” Previously, Necsa’s new reactor programme was combined with the much bigger and totally unrelated national project for new nuclear power plants; this is no longer the case. This new Necsa reactor has been designated the Commercial Production Reactor (CPR).
A point that has to be stressed is that, contrary to proposals a few years ago, the CPR is not intended to replace Safari-1. Recent examinations have shown that, despite already being just over 50 years old, the existing reactor is in excellent shape and has a useful life remaining of at least 20 years. “The idea is now to make Pelindaba a two-reactor site,” states Kemm. “After 20 years or so, Safari-1 would be replaced.”
The enormous experience gained with Safari-1 has been applied to the development of the CPR concept. “Safari-1 was designed as a materials testing reactor,” explains Necsa CEO Phumzile Tshelane. “It has various channels from which you can harvest the neutrons that come out.” This is what allows it to be used to produce medical and industrial radioisotopes and for other purposes, such as “doping” (treating with radiation to produce the highest-quality crystals) silicon ingots, for the global electronics industry. It is also why the reactor and its building are not isolated, but have ancillary buildings and facilities close by. These have largely been adapted for the production, packaging and shipping of Necsa’s various radiation and irradiated products. Effectively, the reactor is part of a production complex, while retaining research capability. The layout is very good for Necsa’s commercial purposes, but not optimal.
The CPR will have its own site and its own associated complex within Pelindaba. This will have an optimal layout. “The new CPR complex will be optimised for seamless processes from the reactor to the production of radiochemicals,” he affirms. “We have a concept design for the complex. Detailed design will be done once the technology partner [for the CPR] is chosen.” The complex will include test facilities for the radioisotopes (both medical and industrial) that the reactor will produce. It will also have ‘hot cells’ in which irradiated materials can be safely analysed, providing a research capability.
“The CPR has been specified,” he points out. “We are preparing to speak to potential suppliers on the basis of a request for information. By the end of this financial year – [March 31, 2018] – we should have done that. And then we will proceed to a request for quotation early after March next year. The intention is not to have a very new reactor design – we don’t want the first unit of a new design built here. Nor do we want the last of its kind. We want a recent, but proven, design that uses the same fuel as Safari-1, which we can produce here.” While Safari-1 originally used highly enriched uranium (HEU) as its fuel, it became the first reactor in the world to be converted to use low-enriched uranium (LEU) fuel, a process that was done jointly with the US and which won Necsa’s reactor staff and specialists international acclaim in the nuclear sector. “This conversion from HEU to LEU fuel was done to clearly illustrate to the world that our commercial operations would not be carried out with bomb-grade uranium,” explains Kemm.
It is too early in the programme for there to be a formal budget for it yet. “We have an idea of how much it will cost but we can’t reveal it because it would undermine our negotiations with vendors,” says Tshelane. Necsa hopes that construction of the CPR will start before the end of 2018 and that it will be in commercial operation by 2022. “The critical path runs through certification, licensing, partner selection and construction,” notes Tshelane. “We have highly competent people here,” emphasises Kemm. “We’re not just buying the reactor. We’ll be running the show. We will be in a partnership with the vendor and we’ll effectively build it. The conversion of Safari-1 to use LEU instead of HEU as fuel shows our local expertise.” Other examples of this expertise is that the internationally certified container used to transport its radioisotopes was designed by Necsa, and the corporation was the first agency in the world to produce Mo-99 on a commercial scale using LEU. Indeed, it is now making this LEU Mo-99 expertise available to partners in other countries.
The development of the CPR and its associated complex will also require the establishment of new workshops to support the new reactor (the existing workshops support Safari-1). “The CPR will require capabilities not found anywhere else in South Africa,” notes Tshelane. New training facilities for scientists, engineers and artisans will also be set up, because the CPR and its associated complex will require new specialisations, currently not required for Safari-1 and its complex. Necsa’s highly skilled staff complement will be increased to meet its expanded personnel requirements.
The CPR will not only allow Necsa to increase the output of its current product range, but will also allow it to enter into new business segments. “Expansion also involves bringing to market innovations as well as increasing quantities [of our existing products],” highlights Necsa executive manager: business development Brian Mphahlele. “The idea is also to diversify our products. We will need to produce new isotopes and the CPR will be at the centre of our ability to continue playing in this market.”
“There is a pipeline of medical applications of radioisotopes that needs to be developed and we will create production lines for these within the Pelindaba site,” explains Tshelane. “There is every reason to believe that these new radioisotopes could be produced using the CPR and then be ‘backwards integrated’ into the Safari-1 production complex.”
Mphahlele stresses that Necsa is an intellectual-property-centred organisation and that it will develop its commercial activities by exploiting (and further developing) this intellectual property. “Through Necsa subsidiary NTP Radioisotopes, we’re largely in the active pharmaceutical ingredient (API) isotope business – we’ve conquered this business; we’re one of the world’s leading suppliers,” he explains. “But we cannot continue growing by staying in this sector. To grow significantly, we must get into the production of radiopharmaceuticals. As API radioisotope producers, we are input suppliers into the global radiopharmaceuticals industry. We need to become radiopharmaceuticals producers ourselves.”
The company has decided to increase its commercialisation efforts and has concluded that the best way to do this is by working with other institutions and enterprises. “Last year, the Necsa board decided that the corporation would collaborate with outside companies and take equity participation on a minority basis,” reports Kemm. “In the past, Necsa did not do this and so lost a number of opportunities.” Previously, Necsa innovations were illegally taken up and commercialised by other businesses and the nuclear corporation gained no financial benefit at all. No longer will that be the case.
The new policy is either to create new ventures or to cooperate with, and licence, existing companies. This is already happening. Thus, Necsa has partnered with local broad-based black economic-empowerment (BBBEE) company BGM Pharmaceuticals to finish the development of, produce and market a new product (developed jointly by Necsa and the University of Cape Town) – a radio- pharmaceutical called GluCAB, which is both a diagnostic and therapeutic compound, and BGM is now fully funding its development, the cost of which is estimated at R600-million. “We are planning to elevate GluCAB to blockbuster status,” enthuses Mphahlele. “It will be a home-grown alternative to current, extremely expensive, anticancer drugs. We expect its market launch to be in eight or nine years. To do this successfully, you want partners who engage constructively, understand R&D (research and development), invest in R&D, understand innovation and are able to bring to bear commercial best practice. This sums up Necsa’s BBBEE commercialisation partner.”
Necsa is also examining the opportunities presented by beneficiating uranium and fluorspar. Another area of interest is the manufacturing of valves for nuclear reactors, which have to be irradiated.
“Our business here is to do deep science – and apply it,” affirms Tshelane. “In due course, Pelindaba could become a multi- reactor site.” “We’ve been most pleased at the level of support we received from new Energy Minister [Ms Mmamoloko Kubayi],” reports Kemm. “She fully supports us operating like a business.”