The law system related to regenerative medicine in Japan has been greatly modified in 2015 by the enforcement of the new law aiming to promptly promote the safe regenerative medicine to society. Facilities that manufacture the cell and tissue products for regenerative medicine are, unlike general pharmaceutical facilities, required to handle cells as raw materials that are not necessarily homogeneous in quality, and to establish the manufacturing process for small amount of various kinds of products considering the future modifications of the process due to the technological innovations.
We will provide the advanced engineering services of the facility for the developing regenerative medicine, based on the experiences of EPC services for pharmaceutical facilities and the knowledge accumulated in our laboratory through the research and development of iPS and other stem cells.
Our laboratory for regenerative medicine, and the product of automated cell culture system
Our laboratory at Koyasu office/research park
- Engineering of bio facility that integrate the multi requirement such as pharmaceutical safety, functionality and economy, based on our profound experiences through the EPC project of pharmaceutical facilities.
- Process consulting of cell operation process established by researchers for regenerative medicine from the point of safe and stable mass production based on knowledges on the operations of iPS and other stem cells.
- Support verification of equipment and tools to be adopted to the cell processing facility if they are applicable or not in our laboratory.
- Flexible planning of facility/equipment considering the small amount of various kind of production and introducing the continuously progressing technologies of production process.
- Supports the preparation of SOP (Standard Operation Procedure) that realizes the safe and stable production as the manufacturing procedures have great influences on product quality.
- Engineering of the facility that process and manufacture vaccines, cells and tissues for regenerative and other medical purposes
- Development of manufacturing process for regenerative medicine
- Other Technical consulting related to regenerative medicine business
- A company; EPC for the manufacturing facility for virus vector
- A company; Prototype development of automated immune cell cultivation system
- National project; Development of automated adhesive cell cultivation system