Over the past 18 months, AstraZeneca, Oxford University and its partners and suppliers have been on an incredible journey of developing and commercializing Vaxzevria, the AstraZeneca COVID-19 vaccine. In little over 6 months, AstraZeneca developed the commercial process, analytics as well as scaled up the process to enable the emergency use authorization of Vaxzevria. This presentation outlines the process development and analytical development strategy as well as the technology transfer efforts needed to successfully establish the manufacturing network required for worldwide supply of Vaxzevria.
The presentation will also discuss the analytical comparability strategy that was successfully employed to enable licensure of greater than thirty five drug substance and drug product manufacturing sites that were needed to supply the vaccine to the world. These efforts were foundational to the efforts of AZ and its partners who have thus far supplied over 2 Billion doses of COVID-19 Vaccine to the world.