GC Green Cross announced on the 7th that it has independently established an integrated analysis platform capable of comprehensively evaluating the quality characteristics and degradation causes of mRNA-LNP (lipid nanoparticle) vaccines. The findings of this research were published in 'Pharmaceutical Research,' an SCIE-level international journal, recognizing the company's technological prowess.

Stress Testing Conducted Simulating Environmental Stress In this study, stress testing was conducted that simulated various environmental stresses mRNA-LNP vaccines may experience during distribution, storage, and administration. The research team intensively analyzed how mRNA and LNP structures, as well as protein expression efficacy, change under various conditions such as temperature fluctuations, oxidation, hydrolysis, and physical impact. As a result, they demonstrated a clear correlation between mRNA purity and structural changes in lipid nanoparticles and in vitro protein expression efficacy.

• *Precision Analysis Using Advanced Techniques... Tracking Even Trace Impurities**
• For precision analysis, the research team utilized the following cutting-edge techniques in a multifaceted manner:
• mRNA Damage and Purity Assessment: Utilized ion-pair reversed-phase liquid chromatography (IP-RP HPLC) and capillary electrophoresis (CE)
• Measurement of Micro Changes in Lipid Components: Applied ultra-performance liquid chromatography-charged aerosol detection (UPLC-CAD)
• Observation of Ultra-Fine Structures and Impurities: Directly observed nanoparticle structures using cryo-transmission electron microscopy (Cryo-TEM), and precisely analyzed even trace impurities using mass spectrometry (LC-MS/MS)

Lack of Global Standards... Plan to Establish Commercialization Quality Control Standards The mRNA platform has garnered attention for its ability to enable rapid vaccine development in the event of an infectious disease outbreak, but it is sensitive to external environmental changes such as temperature and oxidation, making quality control technology essential for stable production and distribution. In particular, with sufficiently standardized global quality control guidelines yet to be established, each developer is currently in a position where it must build its own evaluation system.

GC Green Cross plans to apply the integrated analysis platform secured this time to the optimization of manufacturing processes and the establishment of quality control systems not only for the COVID-19 mRNA vaccine currently under development, but also for various future mRNA-based vaccines and therapeutics. Furthermore, the company intends to actively utilize this platform in establishing commercialization quality control guidelines.

Jung-un Hong, Head of the R&D QM Unit at GC Green Cross, stated, "This research is highly significant in that it goes beyond simple stability evaluation to analyze the correlation between quality characteristics and degradation mechanisms, and it presents the possibility of a stability-indicating analysis strategy combining various analytical techniques." He added, "It will serve as a core standard for securing quality reliability in the future commercialization process of mRNA-based products."