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mRNA raw enzymes are key enzymes used in the synthesis of mRNA, catalyzing the synthesis of RNA from a DNA template in vitro or playing roles in mRNA modification and processing. The production process of mRNA raw enzymes typically includes several steps: cloning the gene encoding the target enzyme into an appropriate expression vector and expressing it in a suitable host cell (e.g., E. coli, yeast, or insect cells); large-scale culturing of the host cells expressing the target enzyme; extracting and purifying the target enzyme through cell lysis, centrifugation, chromatography, etc.; assessing the activity, purity, stability, and other quality parameters of the purified enzyme; and finally, lyophilizing the purified enzyme and packaging it into suitable product forms for downstream use. mRNA was first discovered in 1961, but due to its low stability, the development of mRNA-based drugs progressed slowly. In recent years, with the continuous advancement of mRNA synthesis and delivery technologies, the stability and translation efficiency of mRNA have significantly improved, leading to rapid development in mRNA applications. As a highly promising pharmaceutical technology platform, mRNA is widely applied in areas such as infectious disease prevention, cancer immunotherapy, and protein replacement therapy. The COVID-19 pandemic in 2020 catalyzed the comprehensive development of the global vaccine industry, with mRNA vaccines gaining significant attention and recognition due to their short development cycle, fast production speed, and lack of genomic integration risks. mRNA is a single-stranded ribonucleic acid transcribed from DNA, carrying genetic information that guides protein synthesis. mRNA transmits information from DNA to ribosomes, where it is translated into proteins, facilitating various life activities. Currently, most products on the market are mRNA vaccines (prophylactic vaccines). mRNA vaccines mimic the natural infection process of a virus in the body, effectively eliciting both humoral and cellular immunity, with high safety. They can bypass the constraints of strain or serotype acquisition, supporting the development of vaccines for specific antigens. Due to its potential for preventing and treating various diseases, mRNA vaccines are set to replace traditional vaccines as a revolutionary platform, applicable to infectious disease vaccines, prophylactic cancer vaccines, and therapeutic vaccines. mRNA vaccines can induce T-cell immunity targeting specific immune goals more precisely. According to APO Research, mRNA vaccines are suitable for molecules with poor druggability. Many drugs have complex spatial structures, making synthesis difficult, while drugs produced by human cells are more effective. mRNA provides more possibilities for the clinical application of drugs with poor druggability. Additionally, the mRNA platform is flexible; simply changing the mRNA sequence can shift to new molecules and indications. Manufacturers can leverage the mRNA delivery systems and modification methods from previous products, effectively reducing development time and costs. Beyond vaccine applications, another vast market for mRNA is antibody drugs and other protein therapeutics. mRNA drugs can express antibodies or proteins in vivo, replacing the existing treatment methods of producing antibodies/protein drugs in vitro. mRNA drugs use human cells directly as bioreactors, avoiding concerns about correct spatial conformation and post-translational modifications of protein drugs, reducing the need for sequence optimization and complex modification and purification processes. Several mRNA replacement therapies are already in clinical trials.
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