Building an Innovative Integrated Continuous Downstream Manufacturing...

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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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