Sysmex Corporation and Gaudi Clinical Inc., have signed an agreement. This agreement starts a business collaboration and a capital alliance. This partnership will help medical institutions working in regenerative cellular medicine. It focuses on improving quality control in cell manufacturing. This will make treatments safer and better for patients.
Regenerative cellular medicine holds significant promise for treating conditions currently lacking effective therapies. As a new medical field, it needs careful focus on safety and ethics. Collaboration between academia and industry is key for proper development and commercialization under Japan’s Pharmaceuticals and Medical Devices Act (PMD Act).
Regenerative cellular medicine does more than treat serious illnesses. It is also seen to enhance patients’ quality of life. Research focuses on repairing tissues and restoring function for periodontal and joint diseases. Researchers often use platelet-rich plasma in their studies. More local medical institutions, like primary care clinics, are adopting these therapies. This follows the Act on the Safety of Regenerative Medicine. But widespread use faces tough logistical issues. These include transporting and preparing raw cells, collecting data, and training skilled staff.
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To overcome these barriers, Gaudi Clinical provides cell manufacturing services through tightly controlled cell processing centers (CPCs), ensuring the safety and efficacy of cells for Japanese patients. The company also installs kiosk-type cell preparation laboratories-stationary clean booths- next to clinics, supported by dedicated regenerative cell therapy coordinators. This model not only reduces the operational burden on clinics but also enables patients to access regenerative treatments within their primary care environment.
Sysmex, a leader in in vitro diagnostics for over five decades, has been actively expanding into regenerative cellular medicine. In 2024, the company launched specialized research reagents for protein measurement in this field, compatible with its Automated Immunoassay Systems HISCL™-5000 and HISCL™-800. Collaborations with academia and industry suggest Sysmex’s instruments and reagents could be instrumental in quality control testing, helping to scientifically validate cell functions and treatment efficacy.
Through this alliance, Gaudi Clinical– specialized in contract cell manufacturing using kiosk-type labs and Sysmex offering advanced diagnostic tools and reagents—will work together to promote safer, high-quality regenerative and cellular medicine. By combining their expertise, the two companies aim to support medical institutions in delivering scientifically grounded, secure, and accessible regenerative treatments to patients across Japan.
