Volume Production Output
The Korea Atomic Energy Research Institute (KAERI) has developed a technology that can mass produce radiopharmaceuticals.
KAERI’s Proton Science Research Center announced on July 31 that it has developed an analytical method that can isolate copper-67, a radioactive substance used for treatment, in high purity. KAERI plans to begin volume production of copper-67 by 2025. It is expected to set up new options for cancer types that have few treatment options, such as colon and bladder cancer.
Radiopharmaceuticals are a new generation of cancer treatments that combine radioactive substances with proteins (ligands) that specifically bind to cancer cells. In the case of conventional radiotherapy, not only cancer cells, but normal cells are attacked, resulting in significant negative side effects. Radiopharmaceuticals are a kind of cruise missile that accurately delivers radioactive substances to cancer cells. Radiopharmaceuticals have gained a lot of attention recently due to their high therapeutic effectiveness and low negative side effects. However, due to the difficulty of separating and purifying radioactive substances, it has been difficult to mass-produce radiopharmaceuticals of uniform quality.
The technology developed by KAERI researchers is an analytical method that can accurately separate copper-67. Copper-67 is a radioisotope that emits both gamma rays for cancer diagnosis and beta rays for treatment. Diagnosis and treatment can be done simultaneously. The efficacy of the treatment can be seen immediately such as the extent to which the tumor has shrunk in size after treatment.
Copper-67’s short half-life is also a big advantage. The material has a half-life of 2.5 days, which is about 4.2 days shorter than radioactive isotope lutetium-177, which is currently used as a radiopharmaceutical. If the human body breaks down proteins that transport radioactive materials to cancer cells, the radioactive materials can affect other normal cells. Copper-67 has a shorter half-life, so the risk of exposure to radiation is lower, KAERI says.
The reason why copper-67 has not been developed as a medicine is that the gamma radiation emitted by copper-67 is the same as that of gallium-67, an impurity, making it difficult to separate and purify. Based on the difference in the half-lives of the two substances, Park Jun-kyu and his team at the Particle Beam Utilization Research Center at KAERI developed an analysis method that can separate copper-67 using gamma-ray emission intensity and half-life information. This technology is expected to enable stable mass production of high-purity copper-67.
Currently, the KAERI is providing research-purpose copper-67 to major hospitals in Korea. Starting from 2025, they will mass-produce copper-67 using a proton accelerator in Gyeongju, North Gyeongsang Province. Once the mass production process is in place, the technology can be transferred to Korean biotech companies. They can pay to use the accelerator to produce copper-67 and develop it into a medicine.
Global market research firm Clarivate predicts that the radiopharmaceutical market will grow to US$12 billion (about 15.276 trillion won) by 2030. Global pharmaceutical giant Novartis received approval from the U.S. Food and Drug Administration (FDA) for its prostate cancer radiotherapy drug Fluvicto in March 2022. In the fourth quarter (October-December) of 2022, sales of Fluvicto came in at US$179 million (about 228 billion won).
Earlier this year, Novartis disrupted supplies of the drug due to production quality issues. The company aims to resolve the issue and secure 250,000 doses per year by 2024. Experts estimate that selling all 250,000 doses will be able to generate about US$8 billion in revenue at current prices. In addition to Novartis, other global pharmaceutical giants such as Sanofi and Bayer are investing in the development of radiopharmaceuticals.
In Korea, bio companies such as SK Biopharmaceuticals, FutureChem, and DuChemBio are developing radiopharmaceuticals. At a press conference on July 18, SK Biopharmaceuticals designated radiopharmaceuticals one of its main future growth drivers. The company said it plans to develop radiopharmaceuticals by receiving radioactive material actinide-225 from TerraPower, a small modular reactor (SMR) company that received investment from SK Group.