CSL will begin manufacturing the University of Oxford/AstraZeneca AZD1222 Covid-19 vaccine candidate at its advanced manufacturing facility in Broadmeadows in northern Melbourne today.
The high-tech biotechnology plant (pictured) is contracted to AstraZeneca and the Australian Government to manufacture approximately 30 million doses of the AZD1222 vaccine candidate.
In a statement the company said first doses were planned for release in the first half of 2021, pending the outcome of clinical trials and regulatory approvals by the Therapeutic Goods Administration (TGA).
CSL’s Seqirus division is the world’s second largest manufacturer of vaccines, including those for influenza.
The Australian Government has provided support to CSL to buy specialised equipment and production inputs, to recruit and train dozens of production staff, and to reconfigure air handling systems and other modifications at Broadmeadows.
CSL believes it will be able to make AZD1222, a second UQ-CSL V451 COVID-19 vaccine candidate, while maintaining supplies of the company’s vital core biotherapies.
CSL’s Chief Scientific Officer, Dr Andrew Nash said: “This is an important milestone and marks the end of many months of around the clock preparation by our skilled personnel globally within CSL Behring, Seqirus and research and development.
“Both campaigns are still technically challenging but at this time we are tracking well and expect to produce the AZD1222 and the UQ-CSL V451 vaccine for Australia by mid-2021.”
Nash said the company’s first priority resolutely remains the safety and efficacy of the vaccine.
“We are undertaking these manufacturing activities at-risk and in parallel with the clinical trials and approvals processes in recognition of the significant urgency of the COVID-19 pandemic.”
The manufacturing process for the AstraZeneca will start with the thaw of vials containing vaccine cells.
The cells – frozen under liquid nitrogen to preserve their integrity – need to be thawed in preparation for replication in the bioreactors at the company’s Broadmeadows facility.
After growing in the bioreactors, the vaccine is then filtered and purified leaving just the antigen, or vaccine product. It is then ready for final formulation and filling into dosage vials.
The vial thaw milestone follows several months of close collaboration and preparation by CSL and AstraZeneca technical experts.
During 2020/2021, CSL will manufacture eight large scale batches of vaccine drug substance which requires the use of a live adenovirus.
Multiple doses of the UQ-CSL V451 vaccine candidate have already been manufactured at the Broadmeadows facility and are held in readiness to progress the vaccine to Phase 2b/3 clinical trials.
The decision to proceed to the next clinical trial stage will be made once Phase 1 data has been released and analysed.
Picture: CSL Behring/Broadmeadows plant
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