The biopharmaceutical industry is investing in emerging manufacturing technologies because they offer significant advantages to ensure product quality and process controllability, and are critical to modernizing pharmaceutical manufacturing. However, due to the innovative nature of an emerging technology, limited knowledge and experience on the technology may exist.
As part of the White House efforts to modernize the Federal regulatory system for biotechnology products, the United States FDA announced a new program to facilitate the review of submissions to the Agency involving emerging manufacturing technologies likely to improve product safety, identity, strength, quality and purity. Likewise, other health agencies including PMDA and EMA have also developed internal groups for interacting with companies in this area. This session will provide industry case studies of emerging manufacturing technologies and insights to the expectations of working with regulators for implementation.
Session ID: 22038