MEDEZE, Thailand’s Only Private Cell Bank, Receives GMDP PIC/S Certification for Investigational Cell Therapy Products from the Thai FDA

The certified scope covers the manufacture of investigational medicinal products for Phase I and Phase II clinical trials in the biological products category, specifically mesenchymal stem cell therapy products derived from human adipose tissue, or Human Adipose Tissue-Derived MSCs. MEDEZE continues to develop comprehensive infrastructure spanning cell banking and manufacturing processes to support research and the further development of advanced therapy medicinal products, strengthening Thailand’s capabilities in the future medical industry.

Pharmacist Supattra Boonserm, Secretary-General of the Food and Drug Administration, said that the Ministry of Public Health and the Thai FDA have established a key policy to advance and support Advanced Therapy Medicinal Products (ATMPs). These products represent the future of medical innovation and technology, with the potential to transform disease management from symptomatic treatment to therapies that address underlying causes.

ATMPs can expand treatment opportunities for complex, rare, and chronic diseases for which conventional treatments remain limited. The Thai FDA therefore places strong emphasis on promoting Thailand’s medical innovation ecosystem to ensure that Thai people can access high-quality, safe, and internationally compliant therapeutic innovations.

At the same time, the initiative seeks to strengthen Thailand’s biopharmaceutical industry and its ability to independently research, develop, and manufacture medical innovations domestically. This will help reduce reliance on foreign countries and contribute to sustainable national pharmaceutical security.

The Thai FDA held a ceremony to present a Good Manufacturing and Distribution Practice Certificate, or GMDP Certificate, to Medeze Group Public Company Limited. The certification covers the manufacture of investigational medicinal products for Phase I and Phase II clinical trials in the biological products category, specifically mesenchymal stem cell therapy products derived from human adipose tissue, or Human Adipose Tissue-Derived MSCs.

The certification reflects the Company’s readiness, rigorous operational practices, and genuine commitment to elevating its manufacturing, packaging, quality-control, and quality-assurance systems in accordance with international standards. These capabilities will provide a vital foundation for the safe clinical research and development of medicinal products while strengthening confidence among medical professionals, patients, and Thailand’s public healthcare system.

The Thai FDA congratulated Medeze Group Public Company Limited and expressed its hope that this achievement would become an important milestone in transforming Thai research into practical medical innovations and advancing Thailand as a regional hub for advanced therapy medicinal products.

Dr. Veerapol Khemarangsan, Chief Executive Officer of Medeze Group Public Company Limited (MEDEZE), revealed that the Company had received certification from the Thai FDA confirming that its manufacturing facility had passed an assessment in accordance with Good Manufacturing Practice requirements aligned with the Pharmaceutical Inspection Co-operation Scheme, or PIC/S GMP.

The scope specified in the certificate covers the manufacture of investigational medicinal products for Phase I and Phase II clinical trials in the biological products category, specifically mesenchymal stem cell therapy products derived from human adipose tissue, or Human Adipose Tissue-Derived MSCs, for clinical research in humans.

MEDEZE has established an integrated business foundation encompassing cell banking, research, and manufacturing-process development. This foundation connects the Company’s cell banking expertise with the future development of cell therapy products.

Successfully passing the assessment within the certified manufacturing scope enhances MEDEZE’s readiness to collaborate with research organisations and medical institutions in compliance with applicable requirements. The certification also represents another important milestone in the Company’s development of cell manufacturing processes under a verifiable quality system, encompassing facility control, personnel, manufacturing procedures, and quality testing.

Through these efforts, MEDEZE aims to support clinical research and the development of advanced therapy medicinal products in Thailand.

“We remain committed to continuously developing cell-related infrastructure so that every stage is supported by appropriate standards and can be systematically advanced into research applications. This progress reflects MEDEZE’s determination to contribute to strengthening Thailand’s advanced medical industry,” Dr. Veerapol said.

In addition to this manufacturing certification, MEDEZE has achieved certification under the Cell Bank Standard established by Thailand’s Department of Medical Sciences. The Company also holds AABB accreditation and ISO 9001:2015 quality-management certification, as previously disclosed.

MEDEZE will continue applying the relevant standards and licences within their respective certified scopes to support its operations and ongoing research activities.

For individuals seeking a trusted stem cell bank, MEDEZE offers a clear answer through its Cell Bank Standard, PIC/S GMP-certified stem cell processing, internationally recognised ISO 9001:2015 certification, and AABB accreditation.

The Company also employs proven technologies, including the AXP AutoXpress® Platform and cryopreservation technology, to ensure precision and safety throughout every stage of cell separation and banking. Its services cover umbilical cord blood, umbilical cord tissue, adipose tissue, hair follicles, and NK cells, providing a comprehensive range of options to support diverse long-term healthcare plans.

For more information, please visit: www.medezegroup.com/th