Some of the vaccines in use today were originally developed decades ago. But advances in research, expertise and vaccine development equipment provide immunizations from bacterial and viral diseases (antibodies and cell therapy) to more people every year. The Covid 19 pandemic highlights the urgent need to scale up the production of vaccines and ensure an automated as well as reproducible manufacturing environment.
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Vaccines are over-formulated to protect against potency loss
Vaccines start with the isolation of chemically defined media, but they come into being during formulation. The delicate development process stabilizes the separate components into a uniform mixture and prepares it for batch dosing. Cell cultures are often used in the development as well as formulation of Vaccines and has been that way for decades.
When it comes to producing vaccines, mixtures are typically over-formulated above the required potency. This method lowers yield but compensates for any possible degradation throughout the vaccine’s shelf-life.
Reduce vaccine moisture to max 3% with freeze-drying equipment
The process of lyophilization ensures that your biological formula remains stable along the cold chain. For this reason, freeze-dryers have become critical equipment in modern vaccine production.
Vaccine freeze-drying is a complex procedure involving three major steps. At the freezing stage, the solution solidifies with the formation of crystals. During the dehydration phase in a drying chamber, you subject the material to temperatures not exceeding -50 °C and forces water to sublimate. Finally, another round of drying releases any remaining moisture to between 1% and 3%.
Protect diluent from freezing or heating with cold chain storage
Before clinical trials and before the vaccine enters into the arms of patients, your lyophilized vaccines are reconstituted into liquid solutions using a diluent. World Health Organization guidelines warn that vaccine manufacturing is incomplete without the accompanying diluent.
Sterile water is often used as a diluent, but ingredients may contain a range of other substances such as sodium chloride, xanthan, or calcium carbonate. Whatever the composition, diluents must always be kept at temperatures between +2°C to +8°C.
Chromatography technology and mRNA techniques promise more accessible vaccines
Purification of the reaction mixture remains a challenge for large-scale vaccine development and production. But chromatography is emerging as an ideal purification technique for several biopharmaceuticals. Ligands in the chromatography columns form ‘hooks’ that filter out specific contaminants.
Vaccine manufacturers are taking advantage of this purification technique to reduce vaccine production’s financial and environmental costs. This method is attracting particular interest with the development of mRNA vaccines to combine a relatively simple manufacturing process with the high-yield capabilities of chromatography.
Packaging is a crucial step in vaccine production. This step is often forgotten about but is important in ensuring that the vaccines reach their final destination without getting damaged. But more importantly, safe packing means that the vaccines will reach patients without getting contaminated.