INTRODUCTION

Model-Based Systems Engineering (MBSE) is the modern approach in Systems Engineering by harnessing models as the main artifacts of the system development lifecycle, in contrast to a document-based approach. In this work, we infused AI into the MBSE workflow, so-called Model-Based AI-Driven Systems Engineering (MBSE-AI), synergizing 3 key AI paradigms 👉 Generative AI, AI Optimizer, and Agentic AI. The proof-of-concept demonstrates the early-stage development of aseptic production in pharmaceutical manufacturing using MBSE-AI, which can lead to faster and more effective decisions.