(553a) Challenges in Continuous Manufacturing of Biologics: Summary of NASEM Workshop

The National Academies of Sciences, Engineering and Medicine’s Board of Chemical Sciences and Technology hosted a workshop on the above theme on July 30-31, 2018 under the sponsorship of the USDA FDA and BARDA. This presentation will present a summary of the factors and issues underlying the business case for going continuous as well as specific technical challenges identified in upstream processing, downstream processing, product manufacture, integration, and validation. The content of this presentation will draw from the report of the workshop that will be issued late in 2018.