Regenerative medicine manufacturing - a systems engineering perspective

Abstract

This tutorial introduces the basic concepts associated with a regenerative medicine manufacturing (RMM) system. A background of regenerative medicine, the critical factors involved in its scale-up translation, and an overview of a systems engineering approach for RMM system design are presented. From an industrial and systems engineering perspective, the primary focus is on translating the recipes and protocols used in the early production of regenerative cells, tissues, and organs into engineering terms and specifications. The intent is to identify early constraints on the resources and process methods and develop formal system models, which are a key resource for efficient, cost-effective production of regenerative products.