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

CBER seeks 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. One such technology is continuous manufacturing, defined as manufacturing using a continuous process, rather than a batch-process approach. This emerging technology has the potential to improve agility, flexibility, cost, and robustness in the manufacturing processes for complex biologics. In general, CBER seeks to enhance development of innovative technologies with the potential to address product shortages, improve product quality, and accelerate the time to market for complex biologics such as vaccines against influenza and other emerging diseases. 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. Additionally, this research is intended to support advances in regulatory science that allow for development of science and risk-based guidelines to facilitate faster adoption of these innovative technologies. Some specific areas of research could include the following and the application should clearly describe the potential impacts of the proposed technology on the readiness for broad implementation in the biological product industry, control strategy, and/or regulatory evaluation: • 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