SpikeVax and Establishment of a Vaccine Platform

The rapid introduction of a pandemic vaccine created a challenge to the classical sequential approach to process characterization, transfer, and validation at production scale. The lessons learned from this unprecedented opportunity allows for rapid introduction of related variants. Further, the lessons learned influenced decisions in establishing a vaccine platform process which will allow for faster transfer of additional vaccines to market with less onerous process characterization, technology transfer and process validation activities. Considerations for consumables selection, equipment sizing, batch scale, automation, and digital integration was necessary to ensure a robust platform can be established which would accelerate speed to market while not introducing additional risks that would require rework in the future.