IAEA Works with Cuba to Ensure Good Manufacturing Practices of Medical Radiopharmaceuticals

centro cuba Cancer, cardiovascular and other chronic diseases continue to take a toll on populations worldwide. Early and accurate diagnosis is absolutely essential for effective treatment of patients. Nuclear medicine, through the use of medical radiopharmaceuticals – radiolabelled single molecules or nanosized particles, injected into the human body and detected by their emission of gamma rays that are afterwards converted into images, – is used for both, diagnosis and treatment via imaging techniques such as single photon emission computed tomography (SPECT) and positron emission tomography (PET).

The most commonly used radionuclide Technetium-99m, a daughter product of the decay of Molybdenum-99, is employed in almost 80% of all diagnostic nuclear medicine procedures in the world. Due to its relatively short half-life, Molybdenum-99 has to be supplied weekly to hospitals, in the form of a Molybdenum-99/Technetium-99m generator, to meet the demand. With the ageing of the global population, the demand for medical radiopharmaceuticals is on the rise. Five government-owned reactors supply about 95 percent of the worldwide demand of Molybdenum-99: Belgium´s BR2, Canada´s NRU, France´s OSIRIS, the Netherland´s HFR in Petten, and South Africa´s SAFARI-1.

centisThere are several other smaller reactors that make their products available to regional markets. In Cuba, the National Isotope Centre (CENTIS), just outside of Havana, is a key partner for Cuban hospitals providing medical radioisotopes for diagnosis and treatment. Development of national capacities in nuclear medicine has been a priority for Cuban authorities, including a plan to acquire a cyclotron and several PET scanners.

“Our mission is mainly to satisfy the national demand of nuclear medicine products. We meet 100% of the national demand for radiopharmaceuticals for diagnosis and treatment purposes. We have some products that we export to other countries in the Central American region,” said Dr Luis Ducat Pagés, Deputy Director of Production and Development at CENTIS. “We are currently treating an average of sixty thousand patients a year with the products that we manufacture here at CENTIS.”

Scientists at CENTIS have participated in several IAEA technical cooperation projects aimed at introducing diagnostic and therapeutic radiopharmaceuticals in Cuba and establishing a national production of Molybdenum-99/Technetium-99m generators, used in the preparation of Tc-99m diagnostic agents. Technetium-99 is the most important radionuclide in SPECT imaging and CENTIS is on its way to produce it according to internationally accepted pharmaceutical quality standards. The requirements for good manufacturing practice (GMP) today are compulsory for the production of medicines in general and for the production of radiopharmaceuticals in particular. The IAEA is working with CENTIS to meet the GMP requirements in the production of Molybdenum-99/Technetium-99m generators.

Adriano Duatti, IAEA’s Radioisotope & Radiopharmaceutical Chemist says “The high level of expertise of radiochemists and radiopharmacists at CENTIS has made it a reference centre for fellowships and scientific visits supported by Agency’s projects. Cuba has also promoted a regional project in the South American region devoted to the education of professionals working in the field of radionuclide therapy.”

The IAEA works with Member States like Cuba to help them improve their capabilities in the production and the use of radioisotopes to support the management of cancer, cardiovascular and other chronic diseases. Through its technical cooperation programme and coordinated research projects (CRPs), the IAEA provides much needed capacity building, equipment and expert advice. This assistance is furthermore strengthened through ARCAL, the Regional Cooperation Agreement for the Promotion of Nuclear Science and Technology in Latin America and the Caribbean. CENTIS recently hosted an ARCAL training course on the practical aspects in the production of Molybdenum-99/Technetium-99m generators, attended by experts from Argentina, Chile, Mexico and Peru.

Production of Molybdenum-99/Technetium-99m generators at CENTISplay
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Video clip: Production of Molybdenum-99/Technetium-99m generators at CENTIS