Since 2020, YJ Biotechnology has been transforming regenerative medicine with its cost-efficient, internationally certified and decentralized one-stop cell manufacturing platform that supports both industrial and academic requirements for stem cells and exosomes.

A pioneer in Taiwan’s advanced cell manufacturing technologies, YJ Biotechnology has rapidly emerged as one of the country’s leading names in regenerative medicine. Leveraging high-quality and high-efficiency cell mass production expertise, the company has developed its revolutionary PIC/S GMP-in-Design Intelligent Cell Manufacturing Platform — a highly integrated, miniature facility that significantly reduces cold-chain logistics costs from production to clinical application. This platform also houses Taiwan’s first pharmaceutical-grade isolator designed and manufactured specifically for large-scale cell production.

Thanks to these innovations, in 2024 YJ Biotechnology became the first Taiwanese company to receive GTP certification for its Cell Processing Unit (CPU) featuring its proprietary Pharmaceutical Isolation Equipment (YJ-Isolator), alongside ISO/IEC 17025 certification for its quality control laboratory. “Our technology achieved remarkable progress last year with these key certifications and national awards, such as the Innovation Brands Golden Ship Award, the National Innovation Award and the Business Startup Award,” says Carlos Wu, CEO of YJ Biotechnology.

Although still a relatively small company, YJ Biotechnology’s proprietary technologies and patents enable it to meet the cellular demands of both large-scale industrial production and academic clinical trials. On one front, the company partners with medical institutions to establish miniaturized smart cell factories strategically located worldwide, ensuring accessible and localized cell sources. On the other, it collaborates with top-tier research institutions and companies to accelerate the development of next-generation cellular therapeutics for degenerative diseases and cancer — including Autologous Immune Cell Therapy (CIK) for stage IV solid tumors.

Currently, YJ Biotechnology’s production is split between 60% exosomes (sourced from umbilical cords) and 40% stem cells, serving other companies within Taiwan. In 2025, the company plans to launch turnkey solutions overseas, with an initial focus on Southeast Asia — including Thailand, Malaysia, Singapore, Cambodia and Vietnam, where it plans to establish a regional office — and the United States, where it has already engaged consultants to facilitate FDA approvals.

“We are actively seeking partnerships, not only with industry but also with academia,” says Chairwoman Mavis Lee. “With our expertise, we can support pharmaceutical and biotech companies relying on stem cell and exosome manufacturing. We believe that in the future, biomedical companies will become our main partners as we continue to push the boundaries of cell manufacturing innovation for years to come.”

Resource: https://www.latimes.com/specialsupplements/one-world-media/story/yj-biotechnology-cell-manufacturing-platform