Tuesday, October 21, 2025 – Main Conference Day 1Tuesday, 21 October 2025 - JT (Japan Time, GMT+09:00)

This presentation explores the application of modeling and simulation to enhance the analysis and design of pharmaceutical manufacturing processes, with a focus on cell cultivation for monoclonal antibodies (mAbs) and cell therapies. We present the development and implementation of mechanistic and hybrid modeling approaches that provide a deeper understanding of cell culture dynamics and support model-based decision-making throughout process development. y leveraging predictive simulations, our approach has shown the potential to deliver tangible benefits, including a theoretical reduction of labor costs by up to 38%. These real-world impacts are demonstrated through actual case studies that highlight how digital techniques can contribute to efficient process development. The presentation concludes by addressing the required time and cost associated with modeling and simulation, and discusses the key factors that must be considered to maximize their impact in bioprocess development.