In the last few decades, messenger RNA (mRNA) vaccines have evolved from a dubious idea to a clinical reality. The development and industrialization of COVID-19 mRNA vaccine is the most compelling example to prove the above claim. Vaccination with mRNA has several advantages over other vaccine platforms: (i) it is a non-integrating, non-infectious gene vector that can be easily designed to efficiently express any protein, (ii) it has cost-effective and highly scalable manufacturing potential, and (iii) a small dose is sufficient to induce a protective immune response. There is currently a growing interest in mRNA-based technologies for the development of prophylactic vaccines against infectious diseases. The production and development of fully synthetic mRNA vaccines has been gradually accelerated with major technological innovations in RNA chemistry stabilization, biology, and cellular delivery systems.
Production process of mRNA vaccine
The concept of developing an mRNA vaccine is simple, but the process of producing an mRNA vaccine is more complex. Once the antigen of choice from the pathogen target is identified, the gene is sequenced, synthesized, and cloned into the DNA template plasmid (pDNA). In vitro, this template will be transcribed onto an mRNA vaccine that can be delivered into the subject. In vivo, the mRNA vaccine will mimic a viral infection by using the host cell to translate mRNA into the appropriate antigen, triggering a robust humoral and cellular immune responses.
Figure 1. The mRNA is synthetically produced and formulated into vaccines 
The production process of mRNA vaccines can be broadly divided into six steps as follows.
(i) Sequence design: The sequence of the antigen is designed and optimized based on the sequence of the pathogen genome and inserted into the plasmid DNA.
(ii) In vitro transcription: Plasmid DNA is transcribed into mRNA by bacteriophage polymerases in vitro.
(iii) Purification: mRNA transcripts are purified by high performance liquid chromatography (HPLC) to remove contaminants and other reactants.
(iv) Nanoprecipitation: Purified mRNA is mixed with lipids in a microfluidic mixer to form lipid nanoparticles (LNP). Rapid mixing causes the lipids to encapsulate mRNA instantaneously and precipitate as self-assembled nanoparticles.
(v) Filtration: The nanoparticle solution is dialyzed or filtered to remove non-aqueous solvents and any unencapsulated mRNA.
(vi) mRNA vaccine: The filtered mRNA vaccine solution is stored in sterilized vials.
Solutions for mRNA vaccine production
The huge market demand for mRNA vaccines is forcing the production of mRNA vaccines to be imminent. With in-depth knowledge of nucleic acid theory and advanced mRNA vaccine technology, Alfa chemistry has the ability to produce mRNA vaccines with strong immunogenicity. Our solution includes not only the production of self-amplifying or replicon mRNA vaccines, but also of non-replicating mRNA vaccines.
Why choose us
Alfa Chemistry guarantees to provide customers with efficient and high-quality mRNA vaccine production solutions. If you have any questions related to mRNA vaccine production, please feel free to contact us.
- Chaudhary. N.; et al. mRNA vaccines for infectious diseases: principles, delivery and clinical translation. Nature Reviews Drug Discovery. 2021, 20: 817-838.
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