An agreement has been made to utilize the advantage of stem cells from human exfoliated deciduous teeth (SHED) under development by Japan-based Kidswell Bio.
Kidswell is entering into the agreement with Showa Denko Materials Co., which will also enable process development as well as clinical manufacturing of cell therapy products.
Under the terms of agreement, Minaris Regenerative Medicine Co., Ltd., a subsidiary of Showa Denko Materials, will provide service regarding process development and aims for clinical manufacturing of cell therapy products by the end of 2024.
Cell therapy
Kidswell Bio intends to initiate clinical trials in cooperation with its partner pharmaceutical companies or partner medical institutions.
Kidswell says biosimilar business is its business foundation, and it is accelerating its research and development activities to develop cell therapy products, aiming to create new pharmaceuticals and therapeutics for pediatric 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 has been collecting data which indicate effectiveness of SHED for spinal cord injury, cerebral palsy, refractory fracture, and other conditions. In addition, Kidswell Bio says it is engaged in research for the creation of designer cells, next-generation cell therapies that will further enhance therapeutic efficacy by combining various technologies and devices with SHED.
New treatment methods
Under the 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.
Showa Denko Materials owns Minaris Regenerative Medicine Group, which is a global contract development and manufacturing organization (CDMO) for regenerative medicine products.
Cell expansion
Minaris has facilities located in Japan, the U.S., 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) in the U.S., and good manufacturing practice (GMP) in Europe.
Furthermore, 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.
Minaris’ 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.