2022年10月14日

搜索工作14 - 2022年10月——昭和电工材料和Kidswell生物订约过程开发和临床细胞治疗产品的制造昭和电工材料和Kidswell生物订约过程开发和临床细胞治疗产品的制造东京,日本,10月13日2022 / B3C新闻专线/——昭和电工材料有限公司有限公司(总部:Chiyoda-ku,东京;总裁兼首席执行官:Hidehito高桥;以下简称“昭和电工材料”)和Kidswell生物公司(总部:东京都中央区东京;总裁兼首席执行官:Masaharu塔尼语;以下“Kidswell生物”)达成了一项协议,使过程开发以及临床细胞治疗产品的制造* 1利用的优势流* 2(人类脱落乳牙干细胞)由Kidswell正在开发的生物。根据协议,Minaris再生医学有限公司有限公司(总部:Yokohama-shi,神奈川;购物总裁兼首席执行官:弘人免不了偶),昭和电工材料的子公司,从事关于过程开发和提供服务的目的为临床细胞治疗产品的制造到2024年底。Kidswell生物打算开始临床试验合作医疗机构与合作伙伴制药公司或合作伙伴。与生物仿制* 3业务作为业务基础,Kidswell生物正在加速开发细胞疗法产品的研发活动,旨在为儿童创造新的药品和治疗疾病除了棘手和罕见疾病。棚,牙髓干细胞来源于神经嵴细胞,* 4有望应用于疾病的神经和肌肉骨骼系统。 Through in-house and collaborative researches, Kidswell Bio has been collecting data which indicate effectiveness of SHED for spinal cord injury, cerebral palsy, refractory fracture, etc. In addition, Kidswell Bio is engaged in research for the creation of designer cells,*5 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 (hereinafter “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*6 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 (hereinafter “Minaris”), which is a leading global contract development and manufacturing organization (CDMO) for regenerative medicine products. Minaris 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. 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. Editor Details