Showa Denko Materials Co., Ltd. and Kidswell Bio Corp. have entered an agreement to enable process development and clinical manufacturing of cell therapy products using the advantage of SHED*2 (Stem cells from Human Exfoliated Deciduous teeth) which is under development by Kidswell Bio. Under the agreement, Minaris Regenerative Medicine Co., Ltd., a subsidiary of Showa Denko Materials, will provide process development services and potential clinical manufacturing of cell therapy products by the end of 2024. Kidswell Bio plans to initiate clinical trials in cooperation with its partner pharmaceutical companies or medical institutions.
 

Kidswell Bio is accelerating its R&D 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,*4 is expected to be applied to diseases of nervous and musculoskeletal system. Through in-house and collaborative researches, Kidswell Bio has been collecting data which indicate effectiveness of SHED for spinal cord injury, cerebral palsy, and refractory fracture.

The SHED Master Cell Bank (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. 

 

Showa Denko Materials owns Minaris Regenerative Medicine Group, which is a global contract development and manufacturing organization (CDMO) for regenerative medicine products. Minaris has facilities 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, cGMP of the U.S., and 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.