Professor Jae-woon Son's team from the College of Pharmacy at Jeonbuk National University has developed a next-generation drug delivery system called the 'dual-chamber syringe' (DCS· Dual Chamber Syringe)' by securing a major national project worth 26.3 billion KRW to secure sovereignty over K-Bio.

This project is the 'Bio Industrial Technology - Personalized Diagnostic and Therapeutic Project' led by the Ministry of Trade, Industry and Energy, and Professor Son's team will embark on the development of a closed-type full-cycle manufacturing system and high-concentration formulation-based DCS for next-generation subcutaneous lyophilized biopharmaceuticals based on this selection. This is a massive project with a total investment of 26.36 billion won, including 17.34 billion won in government funding over the next 56 months.

Recently, the global biopharmaceutical market has been rapidly reshaping around 'high-dose subcutaneous injection (SC)' formulations that maximize patient dosing convenience. However, essential convergence platforms such as DCS containers and aseptic finished freeze-drying equipment rely entirely on imports and monopolies by a few global companies, intensifying the 'profit structure distortion' and 'technology security threats' of the domestic K-bio industry.

To overcome these existing limitations, Jeonbuk National University will serve as the overall control tower for this project, promoting 100% localization of the entire manufacturing value chain, including DCS containers, high-content formulations, and freeze-drying equipment. Companies and research institutions with top-level domestic technology participated as detailed lead agencies. The 'Commercialization Dream Team' has been formed to go beyond research and accelerate commercialization.

As for the respective responsible research institutions, Poonglim Pharmatech is responsible for localizing and mass-producing DCS containers; Daewoong Therapeutics is responsible for developing and conducting clinical trials for ultra-high-content subcutaneous injection (SC) formulations; and Ilsin Biobase is responsible for self-sufficiency of intelligent sealed freeze-drying equipment.

Additionally, major universities such as Yonsei University, Mokpo University, Duksung Women's University, Kookmin University, Seoul National University, as well as the Osong Advanced Medical Industry Foundation, LG Chem, and Kyungdong Pharmaceutical, will participate to complete an integrated manufacturing ecosystem of 'materials, formulation, and equipment.'

Professor Jae-woon Son.

The joint industry-academia-research research team is implementing Korea's first data-driven 'intelligent autonomous control (Closed-Loop)' manufacturing process by combining design-based quality advancement (QbD) with real-time process analysis technology (PAT), moving away from traditional post-verification focused production. The company plans to overcome the physicochemical instability that arises during the high-content formulation process of next-generation biopharmaceuticals and secure advanced manufacturing technology at global regulatory levels.

The developed integrated manufacturing solution will be linked and verified with actual production facilities through the Osong Advanced Medical Industry Promotion Foundation with demand companies such as LG Chem and Kyungdong Pharmaceutical, leading to immediate commercialization.

Professor Son Jae-woon, the chief executive, said, "DCSConvergence pharmaceutical platforms like these are only completed when materials, formulations, and equipment are integrated into one," emphasizing, "Alongside technology development, it is necessary to establish a national-level demonstration infrastructure to reliably verify these technologies."

He continued, "We will foster bio manufacturing technologies linked to AI-based autonomous manufacturing innovation centered in Jeonbuk to simultaneously enhance regional and national industrial competitiveness," and added, "We expect this to greatly contribute not only to import substitution effects through localization of core equipment and devices, but also to the development of specialized personnel and the advancement of the regional bio industry ecosystem."

Meanwhile, Professor Jae-woon Son, the lead researcher, has led finished pharmaceutical development and process optimization for over 20 years at GC Green Cross and HanAll Biopharma, and has led the industry-academia-research cooperation network 'Bio Finished Product Research Group.' Currently, the center is building a pharmaceutical industry future talent development center in Jeongeup, Jeonbuk to nurture talent, and is promoting AI-based next-generation pharmaceutical bio process research centered on the Phygital Bio-Rx Lab at Jeonbuk National University.

Jeonju = Reporter Kim Han-sik hskim@etnews.com