Dongnam Regional Nuclear Medicine Center Completes Yeongnam's First GMP Radiopharmaceutical Manufacturing Facility

Southeast Nuclear Medical Center (Director Changhoon Lee) held a completion ceremony on the morning of the 30th after finishing construction of the Southeast Radiopharmaceutical GMP Manufacturing Facility located on the second basement floor of the main building.

The Southeast Radiopharmaceutical GMP Manufacturing Facility is the first GMP facility in the Yeongnam region capable of research and production/supply of clinical radiopharmaceuticals. It can conduct collaborative research with national research institutes, local universities, hospitals, and companies, and by producing and supplying various clinical radiopharmaceuticals, it improves medical accessibility to unmet advanced diagnostics and treatments.

The radiopharmaceutical GMP manufacturing facility is equipped with manufacturing rooms containing hot cells for radiopharmaceutical synthesis, distribution, and research, as well as automated synthesizers, a quality control room for radiopharmaceuticals, and sterile/microbial limit testing laboratories.

In particular, it is expected that collaboration with the Korea Atomic Energy Research Institute, which is building an export-oriented new research reactor and isotope utilization research center in the Southeast Radiation Medical and Science Industrial Complex, will simultaneously drive regional medical advancement and economic growth through research achievements in the radiation bio field.

Changhoon Lee, Director of Southeast Nuclear Medical Center, explained, "Through the Southeast Radiopharmaceutical GMP Manufacturing Facility, we will be able to produce and supply radiopharmaceuticals using medical radioisotopes produced by the export-oriented new research reactor. By developing new radiopharmaceuticals in collaboration with the isotope utilization research center, we expect to create synergy in new drug research for the diagnosis and treatment of intractable diseases, including cancer."

As the first project of the radiopharmaceutical GMP manufacturing facility, Southeast Nuclear Medical Center plans to prepare Ga-68 PSMA-11, a radiopharmaceutical for prostate cancer diagnosis, and conduct PET-CT scans starting this September, marking the first time in the Busan, Ulsan, and Gyeongnam regions.

Ga-68 PSMA-11 is a radiopharmaceutical that selectively binds to the Prostate-Specific Membrane Antigen (PSMA), which is specifically expressed in prostate cancer cells. PET-CT scans using Ga-68 PSMA-11 are proven to be safe and effective for staging, recurrence diagnosis, and treatment response evaluation in prostate cancer patients. In particular, it is known for its high sensitivity and specificity, making it useful for assessing the diagnosis and metastasis of prostate cancer.

Hongje Lee, Head of the Research Center (Chief of Nuclear Medicine), stated, "We will provide advanced medical services such as the previously unmet Ga-68 PSMA-11 PET-CT scans for prostate cancer and Lu-177 PSMA radioligand therapy to local residents, thereby improving healthy life expectancy and quality of life. We will also participate in advanced radiopharmaceutical clinical trials at our parent institution, Korea Institute of Radiological and Medical Sciences, to accelerate practical application. Through radiopharmaceutical-healthcare convergence R&D, we expect to drive the future advancement of the radiation bioindustry."

Completion ceremony of the Southeast Radiation Pharmaceuticals GMP Manufacturing Facility. (From left: Kim Jungyoung, Director of Planning and Coordination, Korea Institute of Radiological & Medical Sciences; Lee Hongje, Research Center Director, Southeast Institute of Radiological & Medical Sciences; Kim Kyungmin, Research Director, Korea Institute of Radiological & Medical Sciences; Lee Jinkyung, Medical Director, Korea Institute of Radiological & Medical Sciences; Jung Jongbok, Mayor of Gijang County; Lee Changhun, Medical Director, Southeast Institute of Radiological & Medical Sciences; Kim Beopjong, Hospital Director, Southeast Institute of Radiological & Medical Sciences; Lee Donggyu, Head of Semiconductor and New Materials Division, Busan City)

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