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Spikevax™ Platform Introduction and Qualification

Jun 28, 2022 11:15am ‐ Jun 28, 2022 11:45am

Credits: None available.


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 following presentation discusses a risk based and parallel characterization approach to process validation during the scale up and qualification of the Spikevax vaccine. Prior experience with clinical vaccine programs enabled the established production process to be transferred in parallel with process characterization resulting in accelerated deployment of a validated process. In addition to the rapid introduction and regulatory approval of the vaccine, Moderna has also responded to variants of concern by adapting to a platform process validation and qualification strategy to allow for rapid adaptation of this life-saving vaccine. These additional transfers and validations occur at an even further expedited rate to stay ahead of the continued observation of variants of concern.


  • Aaron Allen, Director, Manufacturing Sciences and Technology, Moderna Therapeutics


Credits: None available.

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