GC Biopharma announced on Tuesday that it has been selected as the lead research institution for the project Development of AI-based Vaccine Manufacturing Variability Control and Intelligent Quality Management System, organized by the Ministry of Trade, Industry and Energy and the Korea Institute of Industrial Technology Planning and Evaluation (KEIT).
The project will involve GC Biopharma collaborating with Mokpo National University, Daegu Catholic University, and the Jeonnam Bio Promotion Agency as joint research partners.
The initiative will span four years and six months, from 2026 to 2030. The participating institutions plan to establish an AI-based smart manufacturing and quality management ecosystem, leveraging the mRNA-LNP and GMP production infrastructure at the Hwasun Bio-Specialized Complex and GC Biopharma’s Hwasun plant.
mRNA-LNP technology encapsulates messenger ribonucleic acid (mRNA), which carries genetic information, in lipid nanoparticles (LNP) for stable delivery to cells within the body. This technology, commercialized through COVID-19 vaccines, is now being utilized as a next-generation vaccine platform.
The primary development goal is to integrate artificial intelligence (AI) with GMP to control variability in real-time throughout the manufacturing process of both the active pharmaceutical ingredient (DS) and the finished pharmaceutical product (DP) for mRNA-LNP vaccines, thereby optimizing quality.
The company plans to minimize quality variability between batches by combining continuous process analytical technology with AI models. This will establish a real-time quality prediction and anomaly detection system, ensuring consistent high-quality vaccine production.
Experts emphasize that securing a swift and consistent quality vaccine supply chain is crucial in responding to periodic pandemic occurrences.
GC Biopharma is a leading domestic company with proprietary technology for the entire mRNA-LNP cycle and dedicated GMP facilities at its Hwasun plant. The company is working to build a digital manufacturing system capable of rapidly responding to future pandemics.
Lee In-kyu, head of GC Biopharma’s Hwasun plant, stated that it aims to successfully develop the AI-GMP intelligent platform to maximize the quality consistency of mRNA vaccines. The goal is to create a core asset that can respond quickly and effectively in the event of a new pandemic.