Abstract
Microphysiological systems (MPS) have been actively developed as a new technology for in vitro toxicity testing platforms in recent years. MPS are culture techniques for the reconstruction of the specific functions of human organs or tissues in a limited space to create miniaturized human test systems. MPS have great promise as next-generation in vitro toxicity assessment systems. Here, I will review the current status of MPS and discuss the requirements that must be met in order for MPS to be implemented in the field of drug discovery, presenting the example of an in vitro cell assay system for drug-induced liver injury, which is the research subject in our laboratory. Projects aimed at the development of MPS were implemented early in Europe and the United States, and the AMED-MPS project was launched in Japan in 2017. The AMED-MPS project involves industry, government, and academia. Researchers in the field of drug discovery in the pharmaceutical industry also participate in the project. Based on the discussions made in the project, I will introduce the requirements that need to be met by liver-MPS as in vitro toxicity test platforms.
Highlights
The development of a new drug takes a long period of time (∼10–15 years) and costs ∼300 billion yen
In this review, I would like to discuss the current state of Microphysiological systems (MPS) development and the points that should be taken into account to enable their usefulness in drug development, focusing mainly on the liver, which is an important organ for drug safety and toxicity assessment, based on the results of the Japanese project in which I participate
According to the draft definition proposed by the Food and Drug Administration (FDA), an MPS is defined as “an in vitro platform composed of cells, explants derived from tissues/organs, and/or organoid cell formations of human or animal origin in a micro-environment that provides and supports biochemical/electrical/mechanical responses to model a set of specific properties that define organ or tissue function1”
Summary
The development of a new drug takes a long period of time (∼10–15 years) and costs ∼300 billion yen. One of the factors responsible for this situation is the complexity and number of steps involved in the drug development process, starting with the screening of tens of thousands of compound libraries, followed by numerous evaluation tests, including efficacy evaluation and safety confirmation tests. This step is necessary to ensure the safety of a chemical substance that will be administered to humans for the first time and to guarantee the therapeutic efficacy and safety of the drug once it is approved. In this review, I would like to discuss the current state of MPS development and the points that should be taken into account to enable their usefulness in drug development, focusing mainly on the liver, which is an important organ for drug safety and toxicity assessment, based on the results of the Japanese project in which I participate
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