SES101a - Vaccine Production Case Study: Spikevax Introduction

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 Moderna's risk based and parallel characterization approach to process validation during the introduction of its drug substance manufacture of the Spikevax vaccine. Moderna transferred in the production process in parallel with process characterization resulting in accelerated deployment of a validated process.

In addition to the rapid introduction and regulatory approval of the prototype vaccine, Moderna has had to respond to variant mutations to allow for further production of this life-saving vaccine. These additional transfers and validations occur at an even further expedited rate to stay ahead of the continued mutation. The approach to variant production will also be discussed.