Abstract
MPS（Microphysiological Systems） are emerging as highly promising systems in terms of the ability to mimic physiological conditions through perfusion culture via microfluidic devices and/or three-dimensional arrangement of human cells. In 2022, the FDA Modernization Act 2.0 marked a significant turning point in drug development, as it eliminated the mandatory use of animal testing and explicitly recognized MPS as an example of alternative testing methods. This shift indicates a paradigm change from traditional animal models toward innovative technologies that mimic human physiological functions. Going forward, particularly for modalities involving highly specific antibodies and cells that are significantly influenced by the microenvironment of target sites, it will be essential to appropriately select and apply both animal testing and its alternatives. This paper discusses the current status and future perspectives of MPS research and development in academia, focusing on the concepts of “alternative methods” and “human physiological mimetic systems.”
