This step is key since the lipid-based capsule serves as an envelope for the mRNA, when injected in the human body, to enter the cell's cytoplasm with high stability and without disintegration. With a flowrate ratio of 3:1, the mRNA is encapsulated into the lipid mixture in the microfluidics devices to make lipid nanoparticles (LNPs). The purified mRNA is then diluted in 50 mM sodium acetate and fed to one of the twenty-five 16X microfluidics devices along with a mixture of lipids in an ethanol buffer. The mRNA is purified through two diafiltration steps with an 100 kDa MWCO, a chromatography column to remove undesired dsRNA and a sterile filter to remove biological impurities. The pDNA is fed to a WAVE bioreactor for an in vitro transcription (IVT) reaction that produces mRNA through phage T7 RNA polymerase. The process uses Pfizer's pharmaceutical formulation and starts with a plasmid DNA that contains the genetic code for the entire viral spike (S) glycoprotein. This proposal is for a manufacturing process to produce 200 million sterile doses of an mRNA vaccine against SARS-CoV-2 in a 13-week period thereby vaccinating 100 million people. This is tremendously advantageous since the same manufacturing process can be used for the mRNA strand of any genetic mutation of a virus or even for a completely different pathogen. In this manner, the process is independent of the actual disease the vaccine targets and is only dependent on the biological properties of an mRNA strand. Among the many advantages of this new technology is that the manufacturing process, rather than being specific to a virus or recombinant protein, is specific to mRNA. In this manner, mRNA vaccines create antibodies and build immunity towards pathogens resulting in the same protection as traditional vaccines yet without presenting the body with the foreign virus. Unlike pre-existing vaccine technologies, mRNA vaccines present the human body with the genetic information to make a protein whose production incites a natural immune response. MRNA vaccines are a new frontier of medicine.
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