Nuclear Research Institute "Increased Pediatric Cancer Drug Production through Optimal Process Design"

The Korea Atomic Energy Research Institute announced on the 13th that it has successfully optimized the manufacturing process of the pediatric cancer treatment drug CARIEM IBG (I-131 mIBG) by introducing 'Quality by Design (QbD)' based on design into the manufacturing process of radiopharmaceuticals for the first time in Korea.

Researchers at the Radioisotope Pharmaceuticals Support Center of the Korea Atomic Energy Research Institute are holding a meeting to find the optimal process parameters for the pediatric cancer treatment drug Carimibg (I-131 mIBG). Photo by Korea Atomic Energy Research Institute

QbD is a technique that plans and designs the quality of pharmaceuticals in advance to produce optimal results. In the United States and Europe, the application of QbD is mandatory when manufacturing pharmaceuticals.

This concept is more advanced than the Good Manufacturing Practice (GMP) standards. From the early stages of drug development, it involves thorough analysis of the product and risk assessment based on scientific knowledge to manufacture drugs suitable for patients, thereby enhancing safety and efficacy. It also consistently maintains product quality while reducing unnecessary time and costs.

The Korea Atomic Energy Research Institute applied QbD to the manufacturing process of the pediatric cancer treatment drug, reducing production time from the existing 30 minutes to 5 minutes, and increasing productivity based on raw material quantity from 60% to 67%. The reduction in operation time also means that workers’ exposure to radiation is decreased, which adds significance in ensuring the safety of radiation workers.

Previously, Yumi Jeong, Principal Researcher at the Radiopharmaceutical Support Center of the Korea Atomic Energy Research Institute, conducted this research jointly with Jongmin Kim, CEO of Hangaram Management Innovation Research Institute, over two years.

The research team first analyzed risks when producing pharmaceuticals using product and process risk assessment tools, then identified that time and temperature are critical factors in the radio-labeling process, which involves binding radioactive isotopes to pharmaceuticals. They subsequently succeeded in deriving the optimal labeling time and labeling temperature that satisfy both production time and product yield conditions.

Based on the research team’s achievements, the Radiopharmaceutical Support Center plans to continuously maintain the application of QbD to radiopharmaceuticals, aiming to improve the quality of radiopharmaceuticals required in the domestic medical environment.

In particular, CARIEM IBG, which has become capable of mass production through the application of QbD, is scheduled to obtain approval for changes in the improved process from the Ministry of Food and Drug Safety next year. When QbD is applied, the annual production volume of CARIEM IBG is expected to increase fivefold from 20 Ci (curies, enough for 100 patients) to 100 Ci. This is about twice the domestic demand, providing the capacity to export surplus pharmaceuticals.

Principal Researcher Yumi Jeong said, “The application of QbD will serve as a foundation for systematically managing the quality of pharmaceuticals and reliably supplying safe medicines to patients,” adding, “Based on the experience of applying QbD to radiopharmaceuticals, we will continue to develop radiopharmaceuticals needed in medical settings.”

This content was produced with the assistance of AI translation services.