Jeonbuk National University (JBNU) Professor Son Jae-woon (School of Pharmacy) and his research team have been awarded a major national project worth KRW 26.36 billion to localize the next-generation drug delivery system 'DCS (Dual Chamber Syringe)', which had previously been entirely dependent on imports, and have begun efforts to secure K-Bio sovereignty.

This project is part of the 'Bio Industry Technology – Personalized Diagnostics and Therapeutics Program' led by the Ministry of Trade, Industry and Energy. With this selection, Professor Son's team will undertake the 'Development of a Closed End-to-End Manufacturing System for Production of Next-Generation Freeze-Dried Biopharmaceuticals for Subcutaneous Administration and High-Concentration Formulation-Based DCS.' This mega-scale project will run for 56 months, with total funding of KRW 26.36 billion, including KRW 17.34 billion in government grants.

Recently, the global biopharmaceutical market has rapidly shifted toward high-concentration subcutaneous (SC) formulations that maximize patient dosing convenience. However, essential convergent platforms such as DCS containers and aseptic finished-product freeze-drying equipment have been entirely imported and dependent on a small number of global companies, deepening distortions in the revenue structure of the domestic K-Bio industry and posing technology security risks.

To overcome these existing limitations, JBNU will serve as the overall control tower for this project and pursue 100% localization of the entire end-to-end manufacturing value chain, from DCS containers to high-concentration formulations and freeze-drying equipment.

In particular, companies and research institutions with the nation's top-level technical capabilities are participating as lead sub-institutions. Rather than remaining at the research stage, a 'commercialization dream team' has been assembled to accelerate market entry.

As lead institutions for the respective subprojects, Poonglim Pharmatech will localize and mass-produce DCS containers, Daewoong Therapeutics will take charge of developing ultra-high-concentration subcutaneous (SC) formulations and their clinical trials, and Ilsin BioBase will lead efforts to achieve independence in intelligent sealed freeze-drying equipment.

Major universities including Yonsei University, Mokpo National University, Duksung Women's University, Kookmin University, and Seoul National University, together with the Osong Advanced Medical Industry Promotion Foundation, LG Chem, and Kyungdong Pharmaceutical, will participate to complete an integrated manufacturing ecosystem that covers materials, formulations, and equipment.

The joint industry–academia–research team will implement, for the first time in Korea, a data-driven 'intelligent closed-loop' manufacturing process that departs from production centered on post-release verification by combining design-based quality enhancement (QbD) with real-time process analytical technology (PAT).

Through this approach, the team plans to overcome physicochemical instabilities that occur during the high-concentration formulation process of next-generation biopharmaceuticals and to secure advanced manufacturing technologies that meet global regulatory standards.

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

The project's overall leader, Professor Son Jae-woon, said, 'Convergent drug platforms such as DCS are only complete when materials, formulations, and equipment are integrated as one,' and emphasized that 'alongside technology development, national-level demonstration infrastructure is required to validate this reliably.'

He added, 'We will cultivate bio-manufacturing technologies linked to AI-based autonomous manufacturing innovation centered in Jeonbuk to simultaneously raise regional and national industrial competitiveness,' and said, 'We expect that localizing core equipment and devices will not only replace imports but also greatly contribute to training specialized personnel and advancing the regional bio-industry ecosystem.'

Meanwhile, the project's PI, Professor Son Jae-woon, is an expert who led finished-dosage-form development and process optimization for more than 20 years at GC Green Cross and HanAll Biopharma, and has led the industry–university–research collaboration network 'Bio Finished Product Research Association.' He is currently promoting talent development through the establishment of a center for training future pharmaceutical industry personnel in Jeongeup, Jeonbuk, and is conducting AI-based next-generation pharmaceutical bio-process research centered on JBNU's Phygital Bio-Rx Lab.