Designing an Undergraduate Cell Engineering Course around End-to-End Manufacturing Decisions ——An Embedded University-Industry Model for Developing Cell-Manufacturing Competence

He Qian, Jiang Wei, Xu Naihan^*

School of Food and Drug, Shenzhen Polytechnic University

Abstract：

Cell Engineering courses are often organised as separate topics such as cell culture, fusion, bioreactors, and cell therapy. This supports technical coverage but can hide the manufacturing logic that connects cell state, process parameters, and product quality. This paper proposes a compact undergraduate course model for senior students in applied biotechnology. The design works backward from product purpose to manufacturing tasks, learning outcomes, activities, and direct evidence. Six modules follow an end-to-end pathway from product context and cell-source control to scale-up, quality attributes, controlled change, and an integrated manufacturing decision. CHO fed-batch culture and autologous CAR T-cell manufacturing are used as longitudinal cases. Industry partners contribute through outcome review, case calibration, and final proposal review. Assessment combines individual evidence, case products, a team dossier, and an individual defence. The model is a blueprint for later classroom evaluation, not a report of measured learning gains.

Key Words：

cell engineering; cell manufacturing; curriculum design; university-industry collaboration; authentic assessment