(696g) Integrating Mechanistic Modeling with Economic Analysis for End-to-End Bioprocess Design and Development

The fast-growing field of biotechnology is at the cusp of a transformative leap where speed, economics, sustainability, and accessibility play essential roles. Therefore, early integration of mechanistic modeling with process/facility models is critical to evaluating and optimizing the economic and environmental impact of the manufactured product. This is essential for the holistic design and development of bioprocesses early in development, where there is the maximum potential to impact on cost and environmental outcomes.

This interdisciplinary approach marries the quantitative precision of mechanistic models, which elucidate the complex biological, chemical, and physical phenomena underlying bioprocesses, with the strategic foresight of economic analysis to assess cost, feasibility, sustainability, and risk. By embedding economic and sustainability considerations directly into the bioprocess design phase, this novel methodology enables the simultaneous optimization of both the technical, environmental, and financial aspects of therapeutic manufacturing. It facilitates the identification of cost-effective, scalable, and sustainable bioprocessing routes right from conception, thus significantly reducing development time, resources, and the risk of late-stage failures.

This presentation elucidates this integration's principles by showcasing its application through case studies that integrate mechanistic models for cell culture, harvest, and capture steps with cost and sustainability analysis within the BioSolve environment. Through multi-objective Bayesian optimization, we can identify the best solution space that minimizes cost and environmental impact, thereby providing insights into tradeoffs regarding cost and sustainability.

Integrating mechanistic and whole process models provides analysis that accelerates the path from lab to patients. It promises to enhance the viability and impact of biotechnological innovations in addressing global therapeutic challenges.