Application of Microphysiological Systems (MPS) to Drug Safety and Toxicity Testing and Challenges to Its Industrial and Regulatory Implementation

Abstract

The development of microphysiological systems (MPS) is accelerating in Japan, the United States and Europe aiming improvement of the drug development efficiency. MPS is an in vitro culture system in which a culture environment similar to that of a living body is reconstructed in a small compartment. MPS is a new culture method that combines engineering and cell culture technologies, and problems to be solved are pointed out from a perspective different from those of conventional culture technologies. Therefore, this paper outlines the expectations for social implementation of MPS and the challenges that need to be solved for regulatory acceptance.