Tokyo-based Showa Denko Materials and Kidswell Bio Corporation, also based in Tokyo have entered into an agreement to enable process development as well as clinical manufacturing of cell therapy products utilizing the advantage of SHED (Stem cells from Human Exfoliated Deciduous teeth) which is under development by Kidswell Bio. Under the terms of agreement, Minaris Regenerative Medicine, based in Kanagawa, and a subsidiary of Showa Denko Materials, will provide process development services and aim for clinical manufacturing of cell therapy products by the end of 2024. Kidswell Bio intends to initiate clinical trials in cooperation with its partner pharmaceutical companies or partner medical institutions.
With the biosimilar business as its business foundation, Kidswell Bio is accelerating its R&D activities to develop cell therapy products, aiming to create new pharmaceuticals and therapeutics for paediatric diseases in addition to intractable and rare diseases. SHED, which are dental pulp stem cells derived from neural crest cells, is expected to be applied to diseases of the nervous and musculoskeletal system.
Through in-house and collaborative research, Kidswell Bio has been collecting data which indicate the effectiveness of SHED for spinal
cord injury, cerebral palsy, refractory fracture, among others. In addition, Kidswell Bio is engaged in research for the creation of designer cells, next-generation cell therapies that further enhances therapeutic efficacy by combining various technologies and devices with SHED.
Under this agreement, the SHED Master Cell Bank (MCB) established by Kidswell Bio will be utilized for process development and clinical manufacturing of cell therapy products. The SHED MCB is a cell bank to be used as original seed cells for the manufacturing of SHED-derived cell therapy products. Kidswell Bio will promote the development of medical products utilizing the SHED MCB to manufacture not only cell therapy products but also SHED-derived exosome products and new treatment methods by combining SHED with gene therapy. It is an important business basis indispensable for the stable supply of new medicines and therapies.
Minaris is a leading global contract development and manufacturing organization for regenerative medicine products. It has facilities located in Japan, the United States, and Europe, and offers clinical and commercial manufacturing services in compliance with Good Gene, Cellular, and Tissue-based Products Manufacturing Practice (GCTP) of Japan, Current Good Manufacturing Practice (cGMP) of the United States, and Good Manufacturing Practice (GMP) of Europe.
Minaris has established a technology for cell expansion using 3D bioreactors which enable manufacturing cost reduction and quality improvement applicable to both adherent and suspension cells.
The company’s experience in manufacturing regenerative medicine products, its technology for utilizing 3D bioreactors, and its global operations were highly evaluated and led to the conclusion of this agreement.