Sydney: Australia has started locally manufacturing a COVID-19 vaccine candidate developed by the University of Oxford from Monday.
Australian biotech firm CSL has confirmed it will commence manufacturing the University of Oxford/AstraZeneca AZD1222 COVID-19 vaccine candidate at its advanced manufacturing facility in Broadmeadows, Victoria.
CSL has separate contracts with AstraZeneca and the Australian Government to manufacture approximately 30 million doses of the AZD1222 vaccine candidate, with first doses planned for release in the first half of 2021, pending the outcome of clinical trials and regulatory approval, the company said in a statement.
The manufacturing process 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. Should the vaccine demonstrate its safety and efficacy in clinical trials that are currently underway, it is anticipated that it will require a two dose per person regime.
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), CSL said.
CSL had already manufactured several doses of another COVID-19 vaccine candidate developed by Australia’s University of Queensland (UQ), which it is holding in readiness to progress to Phase 2b/3 clinical trials.