Development of active targeting methods using designer exosomes

Cell-Free "High-Precision Immune Control": Innovating Drug Discovery by Utilizing Natural Nanoparticles

In Japan, the establishment of systems for social implementation is progressing, including the development of guidelines by the PMDA Science Board's Subcommittee on Therapeutic Products Based on Extracellular Vesicles Including Exosomes. I have personally participated in the discussions and compilation as vice-chairperson, working to create a path for social implementation as a pharmaceutical product.

In parallel with the development of these guidelines, we are also focusing on solving technical issues in cooperation with our partner companies. In addition to establishing high-purity purification and high-sensitivity detection technologies, we are working on the development of single-exosome particle analysis technology, aiming to ensure the homogeneity of the formulation. Furthermore, we have steadily accumulated implementation technologies to bridge the gap from basic research to clinical practice, such as advancing mass purification technology, improving productivity, and searching for long-term storage conditions.

Through collaboration with domestic companies, the National Cancer Center Japan, and the National Institute of Health Sciences, we aim to establish a mass production and quality control system for highly functional, high-quality, and highly safe exosome formulations, thereby accelerating the step up to the clinical stage. To ensure that research results lead to social implementation, we are planning to establish a startup that will serve as the core of exosome drug development. In collaboration with investment institutions, we will accelerate the process to clinical application as a business entity that integrates development, manufacturing, quality, and regulatory compliance.

With the support of this program, we will further strengthen organic collaboration among industry, academia, government, and finance to create innovative, highly functional biopharmaceuticals from Japan for unmet medical needs, such as intractable cancer and rare diseases, and bring new treatment options to patients worldwide. We would also like to contribute to the establishment of an internationally competitive drug discovery infrastructure through the establishment of a comprehensive system, from basic research to manufacturing, quality, regulatory compliance, and human resource development.