Enhancing Innovations in Advanced Manufacturing Technologies for Vaccines against Influenza and Emerging Infectious Diseases

The Food and Drug Administration (FDA) is seeking to support the application of novel technologies for advanced manufacturing of complex biologic products, and innovative analytical approaches to improve product manufacturing and quality through active research. The supported research will advance innovations in manufacturing by developing and making technologies accessible to industry in the near term, and by bridging the gaps between discoveries and the implementation by industry. Some specific areas of research could include the development of cell lines capable of significantly improving recombinant influenza hemagglutinin protein yields, development of improved bioreactor technologies for intensified biomanufacturing of high-quality recombinant protein vaccines, and refinement of vaccine characterization technologies to facilitate more rapid production and lot release. • Development of cell lines capable of significantly improving recombinant influenza hemagglutinin protein yields ≥ 50% over current methodologies • Development of improved bioreactor technologies for intensified biomanufacturing of high-quality recombinant protein vaccines • Refinement of vaccine characterization technologies to facilitate more rapid production and lot release