Manufacturing

The robust pandemic response has seen our manufacturing and supply chain experts, engineers, technical scientist and quality professionals work in parallel with clinical development to rapidly apply innovative thinking to commercial vaccine production.

Delivering vaccine around the world

AstraZeneca takes responsibility for the safety, effectiveness and quality of all the COVID-19 vaccine made in our global supply network of manufacturing facilities across Europe, North, Central and South America, Asia and Australia. This means that every batch made in our supply network must meet the same exacting production and quality standards.

At every stage of the production process there is a continuous demand to test, record, analyse, report, confirm and verify. AstraZeneca’s many years of experience manufacturing our live virus influenza vaccine means that our COVID-19 vaccine operation was built on solid foundations and strong expertise.

Only through comprehensive planning, creative thinking, rapid problem solving, continuous collaboration with all our partners, and 24/7 commitment, have we been able to contribute to the global effort to overcome the COVID-19 pandemic.

David Hunt "How the vaccine is produced"

West Chester "Transforming decommisioned space into a vaccine production site"

 

Accelerating vaccine production

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.

 
 

Quality across every batch

Prior to signing supply agreements with our partners, they undergo a rigorous due diligence process, including a quality audit. Each site must also be licensed by the relevant regulatory authority to ensure that products are consistently produced and controlled according to quality standards.

Before manufacturing can begin, the process is validated to ensure essential conditions, controls, testing, and outcomes are achieved. Once manufacturing is underway, robust quality assurance processes reduce the possibility of unexpected changes to the vaccine during production.

Bulk vaccine substance is tested for safety and purity, and the finished product is tested for efficacy, quality and consistency. Some batches are also tested for stability to check how long they can be stored and that they will not be affected by the changes in air temperature, pressure or the vibration they may experience on their journey to patients in remote places.

 

Learn from Veera Padmanabhan, COVID-19 Vaccine Analytical Lead, and Darrin Cowley, Head of Development, Biologics on just this.

 

Each batch of the vaccine undergoes more than 40 different quality control tests during its journey from lab to jab. As the vaccine is based on biological materials, some of these tests take at least a month to complete, and cannot be rushed. However, where possible, we are performing this testing in parallel with the next phase of production to ensure that the batches move forward as rapidly as possible.

AstraZeneca is continually identifying and implementing new ways of working that will accelerate production of COVID-19 vaccine and reduce the time to reach communities.

 

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