November 8, 2020, Melbourne — CSL Limited (ASX:CSL) CSL today confirmed it will commence manufacturing the University of Oxford/AstraZeneca AZD1222 COVID-19 vaccine candidate at its advanced manufacturing facility in Broadmeadows, Victoria, on Monday 9th November.
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 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).
The Australian Government has provided support to CSL in order to augment its capacity and capability to manufacture the AZD1222 vaccine (which requires the use of a live adenovirus). This support has enabled the acquisition of specialised equipment and production inputs, the recruitment, training and redeployment of dozens of additional production personnel, and the reconfiguration of air handling and some structural modification to the manufacturing facilities.
Through extensive company-wide coordination, CSL has scheduled production of AZD1222, in addition to manufacturing the UQ-CSL V451 COVID-19 vaccine candidate, while also maintaining commitments to manufacture the company’s vital core biotherapies.
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.
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.
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.”
Successful manufacturing and supply of AZD1222 under contract to AstraZeneca is subject to Australian regulatory approval. The AZD1222 vaccine has been granted a provisional determination by the TGA in Australia. AstraZeneca will manage the application for registration for the vaccine on the Australian Register of Therapeutic Goods (ARTG).