Chapter 20 - Product and process design: scalable and sustainable tissue-engineered product manufacturing

Abstract

Manufacturing of a tissue-engineered product (TEP) is an essential part of the road from “lab to patient,” with its own set of challenges which are different from those covered in other chapters of this book. In manufacturing, TEP quality is the main consideration, and this is also reflected in the regulatory framework facilitating the commercial manufacturing of these products, ensuring their safety and efficacy for patients. This regulatory framework specifies most of the technical demands that the manufacturing process needs to meet, which are often underdeveloped when the TEP enters preclinical phases. Thus, a certain amount of process development is still needed, and existing strategies allow to do this efficiently and effectively. Besides quality, there are other important considerations such as process scalability and manufacturing cost. From these perspectives, a lot of attention is being devoted in recent years to next-generation processes which are automated, utilize single-use equipment, and rely on mathematical process models for efficient process development and effective process monitoring and control.