Building an Innovative Integrated Continuous Downstream Manufacturing...

Presented by

Irina Ramos, at AstraZeneca, Elizabeth Goodrich at Merck, Kurt Boenning at Cytiva, Paul Gillham at Optimal Industrial Tech

About this talk

Full title: Building an Innovative Integrated Continuous Downstream Manufacturing Platform for the Production of Biologics Presented by Irina Ramos, Director, Bioprocess Technology and Engineering at AstraZeneca, Elizabeth Goodrich, R&D Technical Director at Merck, Kurt Boenning, R&D Engineer II at Cytiva and Paul Gillham, Innovations Director at Optimal Industrial Technologies
  • 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.
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