P37: Non-Traditional Flu Vaccine Manufacturing Facility

Influenza is an annual health hazard that is responsible for 17,000 to 51,000 deaths annually in the United States. Awareness has been increasing due to the H1N1 global pandemic outbreak and subsequent vaccine shortages. Influenza is a lipid-encapsulated RNA virus consisting of four surface proteins essential for infection and replication: M1, M2, neuraminidase (NA), and hemagglutinin (HA). Each year, the World Health Organization issues a recommendation regarding which influenza variants are most likely to cause disease so that vaccine manufacturers can create the annual vaccine. Until recently, all influenza vaccines were produced using traditional technologies in embryonated chicken eggs. Today, new technologies are being used to explore alternative expression systems, and to effectively deliver safe and potent next-generation influenza vaccines under strict time constraints, with significantly reduced lead-time compared to traditional technologies. 

This work explores the selection of a non-egg based expression system as well as the conceptual design of an influenza vaccine manufacturing facility. Many factors were considered during the project from location of the facility to regulatory impact of the new process. A major aspect of the project was determining whether to design a facility with traditional stainless steel technologies or to design with disposable technologies through analysis of cost, efficiency, and safety for both systems.