Vol13-1-e47

12/24

12AIST TODAY 2013-1life-liaison-ml@aist.go.jpFor inquiries about this article : Research Planning Office of Life Science and BlotechnologyGlossary* GMP (good manufacturing practice): Production management and quality control standards for manufacturing facilities with the objective of maintaining the quality of pharmaceuticals. The contents of GMP in Japan are determined by the Minister of Health, Labour and Welfare according to the Pharmaceutical Affairs Law.Our future expectation is that the existing CPCs will remain as major cell production facilities, while the isolator system will be employed by ordinary medical institutionsHydrogen peroxide Vapor generatorHydrogen peroxide cartridgeOperation panelCentrifugal separatorGlovesDecontamination pass boxCell observation monitorHEPA filterCO2 incubatorIsolator systemCell processing center (CPC)Occupied area, contamination risk, maintenance, and costOccupied area, contamination risk, maintenance, and costSecond gowning roomFirst gowning roomCell preparation room 2Cell preparation room 1Cell preparation room 1Sample storage roomPreparation roomMonitoring roomMaterials storage roomSince mesenchymal stem cells (MSCs) can be easily separated from various tissues such as bone marrow or adipose tissue and proliferated, they have been widely used in regenerative medicine applications. We have confirmed not only the effectiveness of MSCs but also their safety in our clinical research with some 100 cases of mainly adult patients. Recently, we have been promoting regenerative medicine for infants and have achieved outstanding treatment results, including the demonstration of clear treatment effects in clinical research of a genetic disease that disturbs bone formation throughout the entire body.AIST established a full-scale cell processing center (CPC) that can maintain a high level of cleanliness to produce MSCs for regenerative medicine, and started clinical application of MSCs ahead of any other institutes in Japan. CPCs are essential, as it is difficult to remove microorganisums from produced cells due to the fact that MSCs themselves are alive. Since then, with our CPC serving as a basic model, many CPCs have been constructed around the country at university hospitals and medical ventures. The total number of CPCs of various sizes established so far is around 90, including 50 designed according to GMP*. GMP facilities have clean rooms for strictly sterile management like those Development of Mesenchymal Stem Cell Production Technology Supporting Regenerative Medicineof semiconductor plants. However, the costs of maintenance and environmental validations necessary to maintain such a high level of cleanliness are not insignificant for a large CPC. It is not easy for an individual medical facility to own and operate a large CPC unless the CPC plays the role of a major cell production facility that provides medical cells to many medical institutions. A large amount of effort is also required to clean and sterilize the facility to prevent contamination. Considering these difficulties, there have been calls for a new cell production system to replace CPCs.In response, we commenced the development of an isolator as a new system to replace the conventional CPC, in collaboration with a corporation, ahead of other institutes. The isolator is like a compact box, not a room-in CPC, that contains a working space in which a high level of cleanliness is maintained completely separate from the external environment. In contrast to a CPC, where there is a risk of the operators themselves contaminating the working space for cell production, the isolator eliminates such risk by completely isolating the working space from the operators. A more practical type of isolator was recently developed based on an isolator for drug formulation targeted at pharmaceutical companies. This new isolator has now been put on the market. At the same time, we are also

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