(389a) Process Development Approach and GMP Implementation of SMB for Protein a Chromatography

In this case-study, we present our strategy implementation of continuous affinity capture in a clinical manufacturing setting. Our framework for process development, model-based scale up strategy, and viral clearance models will be discussed. Additionally, we will showcase the implementation of PAT in the development process for experimental burden reduction, as well as for breakthrough monitoring during manufacturing runs. Finally, we will provide economic feasibility analysis for clinical manufacturing