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mRNA carrying specific protein-encoding information is synthesized through in vitro transcription (IVT), and it is delivered to human cells with the help of lipid nanoparticles (LNPs). The translation mechanism within the cells is then utilized to generate the target protein, thereby triggering an immune response or treating diseases.
Compared with traditional vaccines or antibody drugs, the core advantages of mRNA vaccines and drugs lie in their rapid, flexible, and efficient technical characteristics. Traditional vaccines (such as inactivated vaccines or recombinant protein vaccines) rely on pathogen cultivation or complex protein expression systems, and the R&D cycle often lasts for several years. In contrast, the mRNA technology only requires the gene sequence of the pathogen to design and synthesize the target mRNA, which significantly shortens the time window for responding to emerging infectious diseases.
The mRNA technology has verified its technical feasibility in the field of preventive vaccines and is expanding to other application areas. Currently, in addition to the prevention and control of infectious diseases, certain breakthroughs and progress have been made in its application in the fields of cancer treatment, the treatment of genetic and rare diseases, regenerative medicine, etc.
Vazyme offers a comprehensive process and multi dimensional innovative solution for the research phase of mRNA vaccine/drugs, spanning all aspects from early stage R&D to CMC. By leveraging cutting-edge technology platforms and providing customized services, we assists pharmaceutical enterprises in surmounting key bottlenecks.
(1) Target Discovery and Validation: Screen key targets through genomics or disease mechanism research, such as viral proteins or tumor antigens. Validate the immunogenicity and function of the targets using in vitro experiments and animal models to ensure that they can trigger an effective immune or therapeutic response.
(2) mRNA Sequence Design: Optimize the open reading frame encoding the target protein, adjust the codon bias and GC content, design the 5'/3' untranslated regions (UTRs) to enhance stability and translation efficiency, and introduce modified nucleotides (such as pseudouridine) to reduce immunogenicity.
(3) In Vitro mRNA Synthesis: Synthesize mRNA through in vitro transcription using a linearized plasmid template. Add a Cap structure by enzymatic or co-transcription techniques, and then purify the product by chromatography or magnetic beads to remove impurities and ensure high purity of the product.
(4) Development of Delivery System: Encapsulate the mRNA into lipid nanoparticles (LNPs), control the particle size through microfluidic technology, and optimize the proportions of ionizable lipids, cholesterol and other components to improve the cellular uptake rate and endosomal escape efficiency.
(5) Efficacy, Pharmacokinetics and Toxicology Studies: It is necessary to verify the protein expression, immunogenicity and safety of mRNA in cell lines and animal models. Study the distribution, half-life and protein expression kinetics of mRNA in vivo. At the same time, acute and chronic toxicity and immunotoxicity studies are required.
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mRNA Sequence Design
Development of Delivery System
Pre-clinical Studies
(1) CMC: Through process development, establish GMP-grade processes for mRNA synthesis, purification and LNP encapsulation, and establish corresponding quality control and release standards.
(2) IND (Investigational New Drug) Application: Apply to the regulatory authorities for testing a new drug in humans. It is necessary to submit information including drug manufacturing and control information, non-clinical research data, clinical trial protocols and ethical review materials.
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(1) Clinical Research: Conduct experimental research in accordance with the design and objectives of the clinical trial protocol to provide a basis for market launch.
(2) NDA Application: New Drug Application for the marketing of new drugs
(3) Commercialization: Launch the new drug on the market, carry out batch production, and implement quality control.
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Learn more about our technologies to support antilbody drug discovery.Find the information you need in our educational materials database.
Liu J, Zheng T, Xu L, et al. An improved method for the detection of double-stranded RNA suitable for quality control of mRNA vaccines. Protein Cell. 2024;15(11):791-795. doi:10.1093/procel/pwae043
Cheng F, Li J, Hu C, Bai Y, Liu J, Liu D, He Q, Jin Q, Mao Q, Liang Z, et al. Study on the Characterization and Degradation Pattern of Circular RNA Vaccines Using an HPLC Method. Chemosensors. 2024; 12(7):120. doi:10.3390/chemosensors12070120
He W, Geng Q, Ji G, et al. Effective Synthesis of mRNA during In Vitro Transcription with Fewer Impurities Produced. Molecules. 2024;29(19):4713. Published 2024 Oct 5. doi:10.3390/molecules29194713
He W, Zhang X, Zou Y, et al. Effective synthesis of circRNA via a thermostable T7 RNA polymerase variant as the catalyst. Front Bioeng Biotechnol. 2024;12:1356354. Published 2024 Apr 9. doi:10.3389/fbioe.2024.1356354
Qi S, Wang H, Liu G, Qin Q, Gao P, Ying B. Efficient circularization of protein-encoding RNAs via a novel cis-splicing system [published correction appears in Nucleic Acids Res. 2024 Oct 14;52(18):11410-11411. doi: 10.1093/nar/gkae801.]. Nucleic Acids Res. 2024;52(17):10400-10415. doi:10.1093/nar/gkae711
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