Rapid-response manufacturing of adenovirus-vectored vaccines
). This more than doubles facility output as compared to a facility lacking perfusion in the seed train and using a single production bioreactor, while requiring a proportionately small increase in footprint. Using perfusion for more cell expansion at– 1 reduces the cycle time of the production bioreactors. A single purification train remains sufficient to process the output from both production reactors.
Under an alternative assumption of short-term maximum-capacity operation for emergency response, we estimate that eight such facilities could provide a total of 1 billion doses per month. Although substantial, this would be smaller than the network of facilities that produced ChAdOx1 nCoV-19 in 2021. We believe several existing facilities would be suitable.
Quality control testing is rate limiting for vaccine availability. The timeline we have suggested allows 16 days for release testing of the first clinical trial batch and 35 days for testing the first commercial batch. The difference is due to performing 28-day in vitro culture-based assays for adventitious viral agents and replication-competent adenovirus for commercial material, whereas nucleic acid-based assays are used for clinical trial material.
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