Building an Innovative Integrated Continuous Downstream Manufacturing... - Seguridad Mania.com - España y América Latina

Full title: Building an Innovative Integrated Continuous Downstream Manufacturing Platform for the Production of Biologics -Next generation manufacturing (NGM) for biologics is focusing on cost reduction and smaller facilities for an increased productivity. Integrated continuous bioprocess (ICB) is a powerful way to achieve that. -A streamlined control strategy for AstraZeneca’s development of ICB to test this implementation for 14 days of continuous end-to-end process operation at the clinical manufacturing scale will be presented. -It involves dealing with variable perfusion flow rate, normalization of dynamic perfusion titer profile, sizing between intermittent (bind-elute chromatography) and continuous (viral inactivation) unit operations, and integrating PAT when and where possible. -Some scenarios of in-process divergences and their impact on an optimized downstream process sizing will also be included.