In early 2020 the world was hit by a devastating pandemic caused by the SARS-CoV-2 virus, bringing death and disease to millions and affecting nearly everyone around the globe. After isolating and sequencing of SARS-CoV2 virus, scientists made the sequence public, which allowed companies to rapidly develop new vaccines based on the virus’ spike protein.
One class of vaccines is based on mRNA molecules contained in lipid nanoparticles. In the first step in the development process, a codon-optimized DNA template was synthesized and cloned into an expression vector driving transcription of mRNA molecules encoding the spike protein.
After linearizing the expression vector, full-length mRNA molecules containing a 5’ cap and a poly-A tail were enzymatically synthesized in vitro using the enzyme T7 polymerase and the four nucleotide building blocks, adenine (A), cytosine (C), guanine (G), and the uracil analog pseudouracil ( ?U).
Next, these full-length mRNA molecules were purified to remove any contaminants and reactants. The purified mRNA molecules were then mixed with four different lipids to form mRNA-encapsulated lipid nanoparticles.
The mRNA-based vaccine was then purified further by removing residual solvents and unencapsulated mRNA molecules, formulated, and stored in sterile vials, ready for clinical trials to test its safely and efficacy. By the end of 2020, two different mRNA-based vaccines were approved by authorities for emergency use and have been used for nationwide vaccination campaigns, helping protect billions from developing severe COVID-19 upon infection with SARS-CoV-2. This story illustrates the importance of designing a clear strategy for reaching market approval and the value of interacting with the regulatory authorities.
Want to learn more about this process and how you can maximize your success when seeking market approval? Consider taking our all-new online Market Approval course, with teaching cases and interactive assignments based on real-world R&D projects in both the pharmaceutical industry and academia.
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Market Approval is mandatory at various milestones in the development of your novel biomedical intervention and need to be passed to move your product to the market and beyond.