Green Cross secures precision mRNA vaccine analysis technology, publishes findings in international journal

Green Cross has secured technology capable of precisely verifying the physicochemical stability and degradation mechanisms of mRNA (messenger ribonucleic acid) vaccines, significantly strengthening its quality-control capabilities for commercialization.

The company announced Friday that research precisely analyzing the physicochemical stability and structural changes of mRNA-LNP vaccines had been published in Pharmaceutical Research, a Science Citation Index Expanded-level international academic journal.

The mRNA platform is widely regarded as a next-generation vaccine modality for its ability to enable rapid development and deployment during emerging infectious disease outbreaks, but it is highly vulnerable to environmental stress and demands rigorous quality management. The absence of standardized global quality guidelines has long made establishing an independent evaluation framework a prerequisite for commercialization.

In response, Green Cross simulated harsh conditions encountered during distribution, storage and administration — including temperature fluctuations, oxidation, hydrolysis and physical agitation — to demonstrate from multiple angles the correlations among mRNA purity, lipid nanoparticle (LNP) structural changes and protein expression efficacy.

The research employed a range of advanced precision techniques, including ion-pairing reverse-phase high-performance liquid chromatography (IP-RP HPLC), ultra-performance liquid chromatography with charged aerosol detection (UPLC-CAD), cryogenic transmission electron microscopy (Cryo-TEM) and liquid chromatography-tandem mass spectrometry (LC-MS/MS). Through this work, Green Cross established a proprietary analysis platform capable of verifying the stability of complex mRNA drug products.

Building a precision verification system based on a proprietary analysis platform is considered a core R&D competency in the mRNA vaccine and treatment field, where standardized guidelines remain lacking — one that minimizes development failure risk and proactively demonstrates process optimization and commercialization quality standards.

Green Cross plans to apply the integrated analysis platform to its COVID-19 mRNA vaccine currently under development, as well as to future mRNA-based treatments and vaccines, using it to optimize manufacturing processes, control impurities and establish quality-management guidelines.

Hong Jeong-un, head of Green Cross's R&D QM Unit, said the research "is significant in that it identifies correlations among degradation mechanisms and demonstrates the potential utility of stability-indicating analyses," adding that it "will serve as a key benchmark for securing quality reliability when commercializing mRNA-based products."