Development & Characterization of a Live Seasonal Vaccine

There are numerous challenges associated with manufacturing both non-seasonal and seasonal live virus vaccine such as influenza. The annual viral strain selection, manufacturing, testing and release of a seasonal vaccine under accelerated timelines use various strategies to assure adequate supply in a timely manner. A case study will be presented that explores opportunities to facilitate development, testing, and release of a non-seasonal vaccine based on experience with seasonal vaccines. We will address the key differences in development/validation of lot release assays, in development of key critical reagents and difference in stability programs for non-seasonal and seasonal vaccines. The presentation will also discuss the suitability of use of limited safety and clinical efficacy data for release of a seasonal vaccine. We will also discuss in vivo and in vitro tests for detecting extraneous adventitious agents and typical regulatory filings used during a seasonal campaign.