Spirit Scientific (7790) Becomes first company to receive PMDA certification for Platelet Lyophilization Processing Facilities
On December 1, emerging biotech company Spirit Scientific (7790), listed on Taiwan’s over-the-counter market, announced a major regulatory milestone.
On November 20, the company received notification from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) under the Ministry of Health, Labour and Welfare (MHLW) confirming the successful completion of the overseas specified cell processing facility inspection. This achievement grants Spirit Scientific the Specified Cell Processed Products Manufacturing Certification from the Japanese MHLW, making it the first Taiwanese biotech company to possess PMDA-certified facilities for platelet lyophilized product manufacturing processes.
Spirit Scientific is dedicated to advancing the Biofoundry™ model, which integrates standardized processes, fixed-dose/fixed-quantity protocols, and pharmaceutical-grade management concepts to establish high-quality biological material lyophilization preparation services. The company’s mission is to provide effective clinical solutions for regenerative medicine.
Spirit Scientific noted that Japan is one of the world’s most mature and well-regulated countries in the field of regenerative medicine. Its Act on the Safety of Regenerative Medicine (ASRM) also governs technologies utilizing autologous blood, such as Platelet-Rich Plasma (PRP) therapy. Under this regulation, in addition to submitting a detailed plan, medical institutions must ensure that their cell processing facilities—whether in-house or outsourced—pass a rigorous audit by the PMDA before commencing related operations.
Mr. Tao-Lung Lin, Founder and Chairman of Spirit Scientific, stated, “As a pioneer in the service model for Platelet Lyophilization Technology (PLT) preparation, even though our platelet-related preparation services are fully legal and compliant in Taiwan, with over 40,000 preparation cases accumulated, Spirit Scientific continues to hold itself to international standards. Through high-specification laboratories and stringent preparation procedures, we consistently adhere to the highest standards, ensuring maximum safety and quality in every process. This international certification is the best validation of our team’s world-class capability.”
Mr. Lin further elaborated that Spirit Scientific’s laboratories in both Taiwan and Japan were planned and designed internally by the company. The company also possesses the professional capability to export its “Laboratory Setup Consulting Services.” The Japanese laboratory commenced trial operations in 2025 and is scheduled to obtain PMDA approval in the future, ensuring that all Spirit Scientific global locations adhere to consistent, high-standard regulations.
