GC Pharma secures proprietary platform for mRNA vaccine stability, targets domestic production by 2028

GC Pharma has secured a proprietary platform that verifies mRNA vaccine stability under four conditions using five techniques. The platform focuses on scientifically demonstrating correlations among mRNA purity, LNP (lipid nanoparticle) structure and actual vaccine efficacy, and is expected to be applied immediately to quality control across the company’s pipeline, including COVID-19 mRNA vaccines.

mRNA is an unstable substance that is easily degraded by enzymes in the body. LNP technology, which safely delivers mRNA to target cells, is critical to a vaccine’s success. This was also why early mRNA vaccines from Pfizer and Moderna faced difficulties with global supply because of ultracold cold-chain requirements.

In addition to its stability verification platform, GC Pharma has built a next-generation mRNA-LNP platform that maximizes protein expression and reduces toxicity by applying AI-based codon optimization technology and proprietary UTR (untranslated region) patents. It is the first structure in South Korea to internalize the entire process of mRNA drug development, from discovery through manufacturing.

The platform’s applications extend beyond infectious disease vaccines. A CAR-T (chimeric antigen receptor T-cell) therapy candidate being developed by GC Pharma using its proprietary mRNA technology has produced data showing the killing of up to 99% of B cells associated with cancer in in vitro experiments.

Beginning with vaccines for respiratory infectious diseases such as COVID-19 and influenza, the company plans to expand into rare genetic diseases, chronic inflammatory diseases, personalized cancer vaccines and immuno-oncology drugs. Industry observers expect discussions on joint research and development and technology exports with global pharmaceutical companies to gain momentum based on the platform’s advanced quality-control reliability.

The Korea Disease Control and Prevention Agency selected GC Pharma as the lead organization for its “Support Program for mRNA Vaccine Development in Preparation for Emerging Infectious Disease Pandemics.” The goal is to achieve domestic production of mRNA vaccines by 2028 and establish national capabilities to develop a vaccine within 100 days of a new pandemic outbreak.

South Korea has so far remained a hub for contract manufacturing organization services for vaccines developed by global pharmaceutical companies. GC Pharma’s achievement is being viewed as a case that raises the technological level of K-bio by one step, as the company has secured end-to-end capabilities spanning mRNA-LNP design, quality control and manufacturing.

The global mRNA vaccine and therapeutics market is projected to expand to as much as $71 billion by 2034. With annual growth of 17~34% expected in this market, the reliability of quality-control platforms directly influences negotiating power in technology-export and partnership discussions. Attention is focused on what partnerships GC Pharma will establish in global markets using the newly secured platform as a springboard.