Upstream Processes in Cell Manufacturing for Regenerative Medicine

Abstract

In Japan, the field of regenerative medicine has experienced substantial growth over the past decade with increased clinical research and commercialization. Market formation, lower costs, and quality control of regenerative medicine and other products are required for further growth. To achieve these goals, it is necessary to develop human resources for manufacturing cells and establish a manufacturing technology infrastructure. This article outlines the manufacturing processes of regenerative medicine products and focuses on cell expansion culture technology, an upstream process in the manufacturing process, and introduces the characteristics of representative culture technologies（plane culture method, stirred tank bioreactor, fixed-bed bioreactor）．In research and development stages, it is important to select one of several expansion culture technologies and determine a development strategy. Therefore, we applied each culture technology to a series of manufacturing processes and conducted simulations to evaluate manufacturing costs. Based on the results, we discussed upstream processes suitable for cell manufacturing.