On August 2, YJ Biotech, a leading micro-intelligent cell therapy manufacturer, was invited to participate in the "2024 Regenerative Medicine Industry Symposium," organized by The Capital Group and IR Trust. The symposium focused on the current developments and trends in cell and gene therapy. YJ Biotech shared its recent breakthroughs in intelligent solutions for clinical cell manufacturing and discussed the market opportunities created by the Taiwanese government's strong support for the regenerative medicine industry.
Founded in March 2020, YJ Biotech is Taiwan's first company to independently develop a "sterile isolator device" for cell pharmaceutical use. After three years of innovation and development, YJ Biotech became the first facility to pass the Ministry of Health and Welfare's GTP (Good Tissue Practice) regulations for cell preparation processes using sterile isolator technology. The company has also developed proprietary software, including human-machine interfaces, to provide a comprehensive intelligent solution for clinical cell manufacturing. This enables medical institutions, biotech companies, and other stakeholders in the regenerative medicine supply chain to meet various production needs for immune cells, stem cells, and their derivatives, such as exosomes, used in treating multiple diseases and cancers. The safety of sterile cell preparations is further enhanced through these solutions. YJ Biotech's "Micro-Intelligent Cell Therapy Factory" has already been successfully implemented in cooperation with Tungs' Taichung MetroHarbor Hospital for cell therapy under special regulations.
The regenerative medicine law allows medical institutions to either conduct regenerative technologies themselves or outsource to biotech and pharmaceutical companies. This trend, coupled with advancing technologies and increasing clinical demand, is expected to drive further demand for cell preparation facilities and expand capacity needs. This presents a favorable environment for YJ Biotech's business growth.
Kun-Lieh Wu, the founder of YJ Biotech, noted that traditional cell laboratories often use Biological Safety Cabinets (BSC) in a semi-open process within cleanrooms. Current GTP regulations allow the use of BSCs in cleanrooms with a minimum cleanliness level of ISO Class 7. However, aligning with international GMP standards requires BSC environments to meet ISO Class 5 standards. Upgrading existing facilities to meet these stringent requirements poses significant challenges for medical institutions and existing manufacturers.
YJ Biotech's design focuses on user experience and production efficiency by integrating all necessary elements for cell processing into a Grade A zone cabin. This includes RTP quick-connect incubators, hydrogen peroxide sterilizers, fumigation-resistant optical microscopes, and high-capacity centrifuges. The inner chamber is constructed from 316L medical-grade stainless steel, and H14 HEPA filters maintain an ISO 5 clean environment. Through miniaturization, modularization, and intelligent design, YJ Biotech's "Sterile Isolator Device for Cell Pharmaceutical Use" can establish a GMP-compliant micro-intelligent cell therapy factory within a 40-ping space with a 2.7-meter ceiling height. This helps medical institutions and regenerative medicine companies acquire the necessary cells locally, accelerating clinical trials and bringing the era of cell therapy closer.
Resource (mandarin): 亞家生技獲GTP認可細胞製劑廠
