Professor Zhi-Yong Zhang is a professor at Guangzhou Medical University (GMU) and the founding director of the Translational Research Centre of Regenerative Medicine and 3D Printing Technologies at GMU, as well as the Biomedical Engineering Research Center of Guangdong Province. Additionally, he serves as the Group Leader of the State Key Lab of Respiratory Disease in China. Previously, he was a chair professor at the Fourth Military Medical University (2010-2012) and a Professor/Group Leader at Shanghai Jiao Tong University and the National Tissue Engineering Centre of China (2012-2016). He has been granted several

talent scheme program awards, including the National Talent Program of China (China’s Recruitment Program of Global Experts) Award by the central government of China, the "Eastern Scholar" Distinguished Professor award by the Shanghai government, and the “Outstanding Medical Academic Leader” award by the Guangzhou government.

Over the past two decades, Professor Zhang has focused on clinical translational research in the field of regenerative medicine. He has dedicated his efforts to conducting cutting-edge interdisciplinary research and fostering innovation in the convergence of scientific, industrial, and medical disciplines, such as stem cells, biomaterials, bioreactors, and automation technology. He is pioneering in the use of allogeneic mesenchymal stem cell sources for TERM applications, which have been approved by the Health Sciences Authority of Singapore for the first-in-man clinical trial. He has developed a TERM technology named Autologous Regenerative Factor Cocktail (ARFC), which has been used to successfully heal hundreds of patients, including those with refractory wounds, diabetic ulcers, tracheal stenosis, intrauterine adhesions, and more. He has filed more than 30 patents, published over 80 academic papers in international journals such as Advanced Science, Bioactive Materials, Small, Biomaterials, and authored five book chapters.

He has given plenary, keynote, and invited presentations in more than 50 international conferences and has been granted 17 scientific awards, including the National Award for Science & Technology Progress of China (the First Prize) and the Natural Science Award of the Ministry of Education of China (the First Prize, 2014). His research efforts have led to the successful commercialization and clinical translation of a couple of TERM technologies, including ARFC technologies, bioreactors, stem cell culture media, and more. He has served as a committee member of the Tissue Engineering Technical Committee in the Standardization Administration of China (SAC, the counterpart of ISO) and as a technical reviewing committee member for Class III medical devices for China’s National Medical Products Administration (NMPA, the counterpart of the US FDA). Professor Zhang has actively served in more than 20 international and national academic societies, including as Vice Chair of the Chinese Society of Tissue Engineering and Regenerative Medicine (since 2020) and as the SYIS Chair of TERMIS-AP (2009-2012).

Title：Development and Translation of the DASEA (Digitalized, Automated, Scalable, Enclosed, Activated) Bio-Manufacturing Platform for Stem Cells/Exosomes - From Laboratory Research to Clinical Application

Abstract：

Regenerative medicine represents a new epoch in the field of medical treatment, following small molecule drugs and antibody drugs, particularly for the complex conditions such as degenerative diseases, which are currently difficult to manage with existing treatments. However, its widespread application is impeded by the challenge of clinical-scale stem cell production. To address this bottleneck, we have devoted 18 years to conduct the clinical translation research of stem cells and regenerative medicine, independently developing the DASEATM Bio-Manufacturing Platform, encompassing the whole processes from basic R&D to pilot laboratory trials and, ultimately, mass production. 1) The DASEATM Regen-carrier, specifically designed for stem cells, possesses three unique biomimetic features that facilitate stem cell adhesion and proliferation. It is also biodegradable and implantable. 2) The DASEATM culture medium is a serum-free and animal origin free stem cell culture medium that promotes cell activity. 3) The DASEATM intelligent bioreactor is equipped with a real-time online digital detection system and cloud data, achieving real-time monitoring and digitalization of the entire cell culture process. 4) The DASEATM integrated ultra-clean chamber, known for its rapid construction speed, high cleanliness, and lower operating costs, facilitates the GMP encapsulation of the entire DASEATM platform system. The DASEATM platform offers a one-stop cell preparation solution, suitable for the entire process from laboratory research to clinical-scale application, covering the entire workflow from cell inoculation, expansion, and collection to exosome purification and final product packaging.

The DASEATM Bio-Manufacturing Platform makes a revolutionary advancement in the field of regenerative medicine. It provides an ultimate solution for large-scalable manufacturing of cells and exosomes in a Digitized, Automated, Scalable, Enclosed, and Activated (DASEA) way, achieving an overall cost reduction of 62% when compared to traditional two-dimensional culture techniques. This technology, recognized by several top-tier hospitals, has successfully facilitated the preparation of stem cells and exosomes for clinical treatments, demonstrating remarkable clinical efficacy. The DASEATM platform is dedicated to empowering cell manufacturing, aiming to make regeneration clinically accessible and affordable.