GC Green Cross announced on September 8 that it has been selected as the lead research institution for a project titled '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 (KEIT).
The project will involve collaboration with Mokpo National University, Daegu Catholic University, and the Jeonnam Bio Promotion Agency, with GC Green Cross at the forefront.
The initiative will run from this year until 2030, spanning a total of four years and six months. The participating institutions plan to establish an AI-based smart manufacturing and quality management (AI-GMP) ecosystem, utilizing the mRNA-LNP GMP production infrastructure at the Hwasun Bio-specialized Complex and the GC Green Cross Hwasun plant.
mRNA-LNP technology encapsulates messenger RNA (mRNA) containing genetic information in lipid nanoparticles (LNP) for stable delivery to cells. This technology was commercialized through the COVID-19 vaccine and is being utilized as a next-generation vaccine platform.
The primary goal of the development is to link AI with GMP to control variability in real-time throughout the manufacturing process of mRNA-LNP vaccines, from drug substance (DS) to finished product (DP), and to optimize quality.
The company aims to minimize quality variability between batches by integrating continuous process analytical technology with AI models, establishing a real-time quality prediction and anomaly detection system to ensure consistent high-quality vaccine production.
Lee In-kyu, head of the GC Green Cross Hwasun plant, stated, "We will successfully develop the AI-GMP intelligent platform to maximize the quality consistency of mRNA vaccines and complete a key asset that can respond quickly and reliably to new pandemics in the future."
In related news, GC Green Cross recently received approval from the Ministry of Food and Drug Safety for the clinical trial application (IND) of its high-immunogenic influenza vaccine candidate, GC3114B.
The Phase 2/3 clinical trial will evaluate the immunogenicity and safety of GC3114B in individuals aged 65 and older, comparing it directly with an active control group. GC Green Cross plans to begin dosing the first patient in Phase 2 in the second half of this year, with Phase 3 trials to be conducted as multinational studies.
GC3114B is designed to induce a stronger immune response in older adults by including more antigens than standard-dose influenza vaccines.
The project will involve collaboration with Mokpo National University, Daegu Catholic University, and the Jeonnam Bio Promotion Agency, with GC Green Cross at the forefront.
The initiative will run from this year until 2030, spanning a total of four years and six months. The participating institutions plan to establish an AI-based smart manufacturing and quality management (AI-GMP) ecosystem, utilizing the mRNA-LNP GMP production infrastructure at the Hwasun Bio-specialized Complex and the GC Green Cross Hwasun plant.
mRNA-LNP technology encapsulates messenger RNA (mRNA) containing genetic information in lipid nanoparticles (LNP) for stable delivery to cells. This technology was commercialized through the COVID-19 vaccine and is being utilized as a next-generation vaccine platform.
The primary goal of the development is to link AI with GMP to control variability in real-time throughout the manufacturing process of mRNA-LNP vaccines, from drug substance (DS) to finished product (DP), and to optimize quality.
The company aims to minimize quality variability between batches by integrating continuous process analytical technology with AI models, establishing a real-time quality prediction and anomaly detection system to ensure consistent high-quality vaccine production.
Lee In-kyu, head of the GC Green Cross Hwasun plant, stated, "We will successfully develop the AI-GMP intelligent platform to maximize the quality consistency of mRNA vaccines and complete a key asset that can respond quickly and reliably to new pandemics in the future."
In related news, GC Green Cross recently received approval from the Ministry of Food and Drug Safety for the clinical trial application (IND) of its high-immunogenic influenza vaccine candidate, GC3114B.
The Phase 2/3 clinical trial will evaluate the immunogenicity and safety of GC3114B in individuals aged 65 and older, comparing it directly with an active control group. GC Green Cross plans to begin dosing the first patient in Phase 2 in the second half of this year, with Phase 3 trials to be conducted as multinational studies.
GC3114B is designed to induce a stronger immune response in older adults by including more antigens than standard-dose influenza vaccines.
* This article has been translated by AI.
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