GC Green Cross has established its own platform for the precise analysis of the quality and stability of messenger RNA (mRNA) vaccines.
On August 7, GC Green Cross announced that research analyzing the physicochemical stability and transformation mechanisms of mRNA lipid nanoparticle (LNP) vaccines has been published in the SCIE-level journal Pharmaceutical Research.
mRNA technology offers the advantage of rapidly developing and producing vaccines during infectious disease outbreaks. However, mRNA is vulnerable to environmental changes, and the LNPs used to deliver it can alter their structure and function due to temperature and physical stimuli. With global integrated quality control standards still insufficiently established, it is crucial for manufacturers to secure an analytical system tailored to product characteristics for commercialization.
GC Green Cross conducted forced degradation studies to simulate the environments that vaccines may encounter during distribution, storage, and administration. They applied conditions of temperature variation, oxidation, hydrolysis, and physical agitation, analyzing the correlation between mRNA purity, damage levels, LNP structural changes, and in vitro protein expression efficacy.
Various analytical methods were employed to confirm the characteristics of mRNA and LNPs. The purity and damage of mRNA were analyzed using inverse ion-pair liquid chromatography (IP-RP HPLC) and capillary electrophoresis (CE). Changes in the lipid components of LNPs were verified using ultra-high-performance liquid chromatography with charged aerosol detection (UPLC-CAD).
Using cryo-transmission electron microscopy (Cryo-TEM), the shape and structure of ultra-fine LNP particles were observed, while liquid chromatography-tandem mass spectrometry (LC-MS/MS) was used to measure trace impurities. GC Green Cross explained that this multifaceted analysis confirmed the correlation between the quality characteristics of mRNA pharmaceuticals, their degradation processes, and actual protein expression efficacy.
Hong Jeong-woon, head of the R&D Quality Management Unit at GC Green Cross, stated, "This research is significant not only for evaluating stability but also for analyzing the relationship between quality characteristics and degradation mechanisms. The stability-indicating analytical strategy that combines various analytical techniques will contribute to the commercialization and quality reliability of mRNA products in the future."
Meanwhile, GC Green Cross experienced a significant decline in profitability as high-margin product sales recognition was pushed to the second half of the year. However, the market anticipates that sales from flu vaccines, Aliglo, and Hunterase, along with the reflection of proceeds from the sale of Curevo shares, will lead to a concentrated improvement in operating and net profits in the latter half of the year.
Wee Hae-joo, a researcher at Korea Investment & Securities, noted, "Due to the deferred effects of the second-quarter results, this year's operating performance is expected to be concentrated in the second half." He also projected annual sales of 2.054 trillion won and an operating profit of 70.5 billion won for the year.
* This article has been translated by AI.
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