Application of Membrane Filtration Technology in the Production Process of mRNA Vaccine
Application of Membrane Filtration Technology in the Production Process of mRNA Vaccine
Membrane Filtration Technology
Membrane filtration technology refers to membrane separation technology driven by pressure. Under a certain pressure, when the stock solution flows through the membrane surface, many small micropores densely covered on the membrane surface only allow water and small molecular substances to pass through to become the permeate, while the substances in the stock solution whose volume is larger than the micropore diameter of the membrane surface are trapped on the liquid inlet side of the membrane and becomes a concentrated liquid, thus achieving the purpose of separating and concentrating the original liquid. As a new type of high-efficiency separation, concentration, purification and purification technology, membrane filtration has the advantages of simple operation, small footprint and good separation effect and so on. Membrane filtration technology has developed rapidly in the past 30 years and has been widely used in petrochemical, food, medicine and other fields.
mRNA vaccine
mRNA is a naturally occurring molecule that can produce target proteins, or immunogens, activating immune responses in the body to fight various pathogens. The mRNA vaccine uses the gene sequence of the virus instead of the virus itself. Therefore, the mRNA vaccine does not contain viral components and has no risk of infection. The mRNA vaccine is a new type of nucleic acid vaccine that has emerged in recent years and belongs to the third generation of vaccines. Compared with traditional vaccines, mRNA vaccines are similar to viral infections. The mRNA vaccine can synthesize S protein and then stimulate the body to produce antibodies by simulating viral infection.The mRNA vaccine has the advantages of fast intracellular expression, fast response, strong immunogenicity, high effectiveness and safety, short development cycle and so on. The current mRNA vaccine production process is relatively complicated and cumbersome, while membrane filtration technology runs through the entire mRNA vaccine production process.
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Application of Membrane Filtration Technology in the Production Process of mRNA Vaccine
Different production stages of mRNA vaccines should use different tangential flow filtration forms and membrane filtration products due to different products, impurities and experimental purposes.
①LNP ultrafiltration purification/concentration
After the mRNA is complexed with positively charged materials, an ultrafiltration purification/concentration process is required. During the production of mRNA vaccines, choosing the membrane cassette or hollow fiber with the appropriate cut-off pore size according to the particle size of the mRNA-LNP complex to remove uncomplexed mRNA and free various lipids, increase the concentration of mRNA-LNP complex, replace the buffer and adjust the pH value, etc.
②Sterilization filtration
The sterilization filtration process is a production process that removes microorganisms in the fluid through a sterilization filter to obtain a sterile filtrate. The process of sterilizing and filtering should avoid an adverse effect on the quality of the product. In the production process of mRNA vaccines, sterilization filters with a pore size of 0.22μm are generally used to remove microbial pollutants such as bacteria and improve the safety of mRNA vaccines.
