The Unreasonable Effectiveness of Equations: Advanced Modeling For Biopharmaceutical Process Development

Abstract Advanced modeling based on first principles approaches is an effective methodology for designing biopharmaceutical process and product systems that are reliable, efficient, agile, and differentiated. However, the industrial modeling practice has stagnated despite significant advances in other fields, and the digital accelerators (computing power, storage capacity, and bandwidth) have created a shifting landscape for the foundations of process systems engineering. This article argues for a stronger emphasis on modeling lifecycle frameworks as well as a clear focus on systematic value creation through greater immediate application and sustained utilization of models and advanced modeling methodologies. Convergence between first principles modeling, experimental methods, and machine learning techniques is postulated as the main direction for innovation. Modeling patterns are presented as a novel mechanism to create and reuse effective modeling abstractions. A community-centric approach to collaboration between industry, vendors, and academia is required to deliver these significant innovation needs.

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