The release follows the completion of the final stages of manufacture – known as fill and finish – and extensive quality checks at Seqirus’ vaccine facilities in Parkville, Melbourne.
There are a further 2.5 million doses in cold storage, undergoing the final stages of testing, approval and release, which will be distributed in the coming weeks.
The manufacturing process is ongoing and CSL expects to release an average of a million doses a week over the course of the campaign, subject to regulatory approvals.
Manufacture of the first batch commenced in November at CSL Behring in Broadmeadows with the thaw of a vial of ‘starter material’. Since then, CSL employees have worked at pace to grow the vaccine in 2000 litre bioreactors, before harvesting the bulk drug substance and filtering it into a concentrate, ready for the final stages of filling into vials.
At every stage of the manufacturing process, the vaccine has undergone extensive checks – and no vaccine is released until the Therapeutics Goods Administration, AstraZeneca and CSL confirm the potency and safety of the locally made product.
In addition to rigorous analytical tests on each batch by CSL and the TGA, every individual vial has been visually inspected by a skilled operator to ensure it is fully compliant with safety and quality standards before it is released to the public.
Commenting on today’s milestone, Dr Andrew Nash, Chief Scientific Officer CSL said; “CSL is very proud to mark this milestone today – the culmination of months of work right across the company to deliver locally made COVID-19 vaccines to Australians.
“It has taken a significant collaborative effort to get to this point and I would like to acknowledge all our partners including the Australian Government, AstraZeneca and the TGA for their dedication and rigour to deliver COVID-19 vaccines to the nation.”
The doses will be transported and stored between 2-8 degrees Celsius, and distributed to health care professionals across the country as part of the Australian Government’s COVID-19 vaccine rollout.
Dr Nash continued, “Today’s milestone is the culmination of a whole of company effort - acknowledging that CSL is the only company in Australia with manufacturing facilities capable of producing the AstraZeneca vaccine, we have worked hard to find a way to reconfigure our operations without compromising the production of our core products – influenza vaccines and plasma and recombinant protein therapies. It’s a proud moment for all of us.”
Media Contact - CSL
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About CSL: CSL (ASX:CSL; USOTC:CSLLY) is a leading global biotechnology company with a dynamic portfolio of life-saving medicines, including those that treat haemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL – including our two businesses, CSL Behring and Seqirus – provides life-saving products to more than 70 countries and employs more than 27,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest. For inspiring stories about the promise of biotechnology, visit Vita at CSLBehring.com/Vita and follow us on Twitter.com/CSL