CSL has announced it will commence manufacturing the University of Oxford/AstraZeneca AZD1222 COVID-19 vaccine candidate on Monday 9th November.
The global biotech company has separate contracts with AstraZeneca and the Australian Government to manufacture approximately 30 million doses of the AZD1222 vaccine candidate.
The vaccine will be manufactured at CSL’s advanced manufacturing facility in Broadmeadows, Victoria, with first doses planned for release in the first half of 2021, pending the outcome of clinical trials and regulatory approval.
“The manufacturing process will start with the thaw of vials containing vaccine cells,” CSL said in a statement.
“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.”
According to CSL, eight large scale batches of vaccine drug substance will be manufactured during 2020/2021. The company anticipates that a two dose per person regime will be required, should the vaccine demonstrate its safety and efficacy in clinical trials that are currently underway.
CSL’s Chief Scientific Officer, Dr Andrew Nash, said the vaccine will not be released for use until the relevant clinical trial and manufacturing data are reviewed and approved by the Australian government regulatory authority; the Therapeutic Goods Administration (TGA).
“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,” Dr Nash continued.
“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.
“There’s still a long way to go and our first priority resolutely remains the safety and efficacy of the vaccines we produce.
“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.”