At our cell culture center, we conduct contract services related to cell sheet manufacturing, facility operation, and the preparation of application documents.
Features of Regenerative Medicine Contract Services 1. Development and Contract Manufacturing of Cell Sheet Products We provide contract development and manufacturing services primarily for cell sheets, commissioned by pharmaceutical companies and research institutions. Our team includes clinical culture specialists certified by the Japanese Society for Regenerative Medicine, and we offer high-quality cell sheet product development and manufacturing using experienced staff in a cell culture processing facility licensed for the production of specific cell processed products. 2. Facility Management and Application Support The "Act on Securing Safety for Regenerative Medicine" stipulates the structure, equipment, and operation of cell processing, requiring each cell culture processing facility to submit notifications and applications for permits to the Minister of Health, Labour and Welfare. At CellSeed, we assist with the notification and application documentation for the manufacture of specific cell processed products, as well as the creation of necessary operational documents. Additionally, we support the necessary administrative procedures, including the preparation of consultation materials for authorities regarding applications such as clinical trial notifications. 3. Education for Cell Culture Technicians We conduct training for cell culture technicians who have no prior experience with cell sheets, covering procedures such as cell sheet culture and detachment at our cell culture facility. For more details, please contact us or refer to our catalog.
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basic information
At our cell culture center, we conduct contract services related to cell sheet manufacturing, facility operation, and the preparation of application documents. In compliance with the "Act on Securing Safety for Regenerative Medicine" and in accordance with the "Ministerial Ordinance on Manufacturing Control and Quality Control Standards for Regenerative Medicine Products (GCTP Ordinance)," we provide safe and high-quality products and services through a manufacturing and quality management system led by experienced staff. Additionally, in conjunction with contract manufacturing of cell sheets, we support regulatory compliance, preparation of approval application documents, acquisition of manufacturing and sales licenses, and training of technicians at each stage from product development to manufacturing and sales.
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For inquiries regarding contract services in regenerative medicine, please contact us directly.
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1. Development and Contract Manufacturing of Cell Sheet Products Main Services Development of manufacturing methods for cell sheet products Contract manufacturing of cell sheet products Quality testing of cell sheet products, etc. 2. Facility Management and Application Support Main Services Support for permit applications and notifications Document preparation support and consulting Support for maintenance and management of facility equipment and management systems, etc. 3. Education for Cell Culture Technicians Main Services Training for cell sheet culture Training for cell sheet detachment, etc.
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CellSeed is committed to the belief that "we want to deliver the world's first cell sheet engineering-based treatment to patients around the world as soon as possible," and we are challenging ourselves every day. We will continue our efforts toward the commercialization of cell sheet regenerative medicine products.