vaccine production process

what does it begin with?

< antigen production which varies depending on type of vaccine

< some vaccines rely on cell culture methods where specific cells are grown to produce the required antigen, while others use recombinant DNA technology or viral vectors to generate targeted proteins

once the antigen is produced, how is it formulated?

< with additional components, such as adjuvants, stabilisers, and preservatives, to enhance the immune response and maintain the vaccine’s stability and shelf life

how do adjuvants play a role?

in boosting immunogenicity

< they work by stimulating the immune system to respond more robustly to the antigen, increasing both the strength and duration of the immune response

how do different adjuvants achieve this in various ways?

< aluminum salts, commonly used in vaccines for diphtheria, tetanus, and hepatitis B, promote a strong local immune response;

< MF59, an oil-in-water emulsion used in some influenza vaccines, enhances antigen uptake and activation of immune cells;

< AS01, a combination of monophosphoryl lipid A and QS-21, boosts both cellular and humoral immunity as seen in the Shingrix vaccine; and CpG 1018, a synthetic DNA sequence used in Heplisav-B, mimics bacterial DNA to further stimulate the immune system.

following formulation?

< vaccine undergoes purification to remove any contaminants, ensuring the final product is both safe and effective

< the purified vaccine is then filled into vials or syringes under sterile conditions and packaged for distribution

_{< t}hroughout this process, quality control and assurance measures are strictly enforced

< good manufacturing practices (GMP) are followed to guarantee that every step meets rigorous safety and quality standards, including maintaining aseptic conditions, proper documentation, and regular inspections

< each batch of the vaccine is subjected to comprehensive testing for potency, sterility, and consistency, and post-market surveillance continues even after distribution to monitor for any adverse effects, ensuring long-term safety

what else is important?

< distribution and storage of vaccines

< which must maintain their integrity to ensure effectiveness

< most vaccines require refrigerated storage at temperatures between 2°C and 8°C, though some, such as mRNA vaccines, need ultra-cold conditions of around -70°C.

< Maintaining these temperature ranges requires specialized cold chain equipment, including refrigerated trucks, warehouses, and portable iceboxes, throughout transportation and storage.

< Effective distribution networks are essential to ensure that vaccines reach healthcare facilities intact, allowing them to be administered safely and efficiently to the public.

< The combination of precise manufacturing, rigorous quality control, and meticulous distribution ensures that vaccines maintain their efficacy and safety from production to administration.