3D GLOBAL BIOTECH announced on the 26th that it will set up a wholly-owned subsidiary in San Diego, California, and build a cell GMP manufacturing facility compliant with U.S. FDA standards. This move officially launches the company’s global strategy in regenerative medicine and cell therapy, with plans to complete multiple U.S. clinical trial applications (IND) and international licensing collaborations within five years.
Chairman Ou Geng-Liang emphasized that the United States is a critical market and regulatory innovation hub for regenerative medicine and cell therapy. By establishing operations in California, 3D GLOBAL BIOTECH aims to leverage the region’s concentration of world-class R&D and clinical trial resources while integrating the clinical and research strengths of Taipei Medical University. This will create a “Taipei–San Diego” dual-core operational model, linking Taiwan’s innovative R&D with U.S. clinical applications to build a one-stop international platform spanning R&D, clinical development, and manufacturing licensing.
The U.S. facility will be developed in two phases. The first phase will establish basic infrastructure and quality verification, incorporating an induced pluripotent stem cell (iPSC) platform, exosome extraction and purification technologies, cell cold-chain management systems, and production lines for GMP-grade culture media and cryopreservation solutions. The subsequent phase will expand the facility into a full-scale production base for cell products and exosome raw materials, establishing a clinical manufacturing center compliant with FDA cGMP standards to support IND clinical product manufacturing and regenerative medicine product release.
Additionally, 3D GLOBAL BIOTECH will initiate multiple international clinical collaborations, partnering with U.S.-based medical institutions and clinical CROs (Contract Research Organizations) to target high-potential indications including dry eye disease, retinal degeneration, brain injury, Alzheimer’s disease, degenerative arthritis, bone repair, diabetic nephropathy, and myocardial infarction. The company also plans to establish a Regenerative Medicine Innovation Center in California to serve as its U.S. headquarters, integrating R&D, clinical operations, and commercial licensing, with gradual expansion into European and Asian markets.
Market research forecasts that the global regenerative medicine market will surpass US$90 billion by 2030, with a compound annual growth rate exceeding 20%. 3D GLOBAL BIOTECH expects that the completion of the U.S. GMP facility will accelerate clinical timelines, strengthen international licensing capabilities, and enhance the global visibility of Taiwan’s biotech R&D.
Chairman Ou stated that the California GMP facility represents a key milestone in 3D GLOBAL BIOTECH’s globalization strategy. The Taiwan headquarters will continue to focus on R&D and clinical work, while the U.S. subsidiary will concentrate on manufacturing, regulatory affairs, and licensing operations. Together, they will form a complete system for technology transfer and industry integration, with the goal of completing multiple U.S. IND applications and international licensing collaborations within five years, propelling Taiwan’s regenerative medicine technology onto the global stage.
Resource: 三鼎跨海設細胞GMP廠 啟動台美雙核心布局
