Before sending an inquiry, please first read the frequently asked questions below.
- Is this freeze-drying technology similar to that which is used for the freeze-drying of food (soups, etc.)?
- The overall process is essentially the same for pharmaceuticals as it is for foods. However, for the freeze-drying of pharmaceuticals (lyophilization), the production equipment needs to meet the strict regulations of the pharmaceutical industry.
- When will vaccine production start?
- We hope to begin production in mid-2022.
- After the powdered vaccine is dissolved in water will it be the same as the original liquid vaccine?
- Lyophilized vaccines after dissolving in water (diluent), show the same efficacy as those which have not been lyophilized. Furthermore, clinical trial data proving this is required before these vaccines can be given to the general populace.
- I can understand the lyophilization of proteins, but I don't think freeze-drying technology will work for mRNA because it is more fragile and easily degraded.
Is there any evidence that mRNA can be lyophilized?
- mRNA has been successfully lyophilized in the literature. Additionally, recent vaccines using mRNA as an active ingredient are being formulated with liposomes or lipid nanoparticles. The properties of the formulation are different than naked mRNA.
- Why does making the vaccines into a powder make them more stable?
- Vaccines are unstable in water. By removing the water and creating a powder vaccine, the stability of the vaccine is greatly improved. In many cases, this results in a powder vaccine that can be stored at room temperature.
- What storage conditions and shelf life would a powdered vaccine have?
- There have been many examples in the literature of creating powdered vaccines that are stable at room temperature conditions up to one year of stability or more. We are targeting up to 3 years of stability.