Innovating Production and Manufacture to meet the Challenge of COVID-19
To accelerate vaccine production and supply involves collaboration with more than 20 supply partners in more than 15 countries, supported by more than 20 analytical testing sites.
Our supply chain includes multiple manufacturing facilities across each stage of production - drug substance, drug product, and finished packaging. These partners will collaborate with us throughout the entire manufacturing process, receiving support and technical guidance.
Central to our mass supply capability is defining the chemistry, manufacturing and controls (CMC) of the production process. During CMC, we are developing an optimised, repeatable manufacturing process that delivers maximum yields and ensures high-quality product across our supply chain.
This manufacturing process is then transferred to our partners to establish supply at their respective facilities. Because quality testing is required throughout the manufacturing process, as well as to support product release in market, we have also built an extensive analytical network and are rapidly transferring our analytical methods to these laboratories.
Our procurement team is also working to secure and accelerate a global supply chain of critical raw materials, reagents and consumables in collaboration with our suppliers to enable rapid manufacturing and quality testing.
It is very important to us at AstraZeneca that we can produce as much vaccine as possible to ensure broad, equal access as soon as possible after a potential approval. Accelerating production at this kind of scale requires partners around the world with capabilities to manufacture using our standard process to ensure consistency and quality of the vaccine. We are working tirelessly to establish mass supply globally so if our vaccine is approved by regulators, it will be ready for distribution.
Making a vaccine at a glance
These are the crucial manufacturing processes needed to create a vaccine on an unprecedented scale:
- CMC – A commercial manufacturing process has been developed from an initial small-scale process before rapidly scaling to increase productivity yields, all the time ensuring purity of the final product. This consistent process is employed by each manufacturing facility we are collaborating with.
- Virus seed stock & host cell bank – These starting materials are used by manufacturers around the world to initiate vaccine production.
- Drug substance – Host cells are grown in a series of bioreactors of increasing scale and infected by the virus seed to produce a final vaccine molecule. A series of filtration and chromatography steps are taken to harvest and purify the vaccine.
- Drug product – The drug substance is combined with buffers to achieve a final formulation and then filled into multi-dose vials, which are labelled and packaged.
- Testing and quality control – Extensive testing is conducted on every batch throughout the manufacturing process. Quality control measures are employed at all stages of production to ensure consistency and quality.