ヤマト　マサユキ   YAMATO Masayuki   大和　雅之    所属   研究施設 研究施設    職種   教授
論文種別	原著
言語種別	英語
査読の有無	査読あり
表題	Cell/tissue processing information system for regenerative medicine.
掲載誌名	正式名：Journal of tissue engineering and regenerative medicine 略　 称：J Tissue Eng Regen Med ISSNコード：(1932-7005)1932-6254(Linking)
掲載区分	国外
巻・号・頁	10(11),pp.908-915
著者・共著者	IWAYAMA Daisuke†, YAMATO Masayuki, TSUBOKURA Tetsuya, TAKAHASHI Minoru, OKANO Teruo*
担当区分	2nd著者
発行年月	2016/11
概要	When conducting clinical studies of regenerative medicine, compliance to good manufacturing practice (GMP) is mandatory, and thus much time is needed for manufacturing and quality management. It is therefore desired to introduce the manufacturing execution system (MES), which is being adopted by factories manufacturing pharmaceutical products. Meanwhile, in manufacturing human cell/tissue processing autologous products, it is necessary to protect patients' personal information, prevent patients from being identified and obtain information for cell/tissue identification. We therefore considered it difficult to adopt conventional MES to regenerative medicine-related clinical trials, and so developed novel software for production/quality management to be used in cell-processing centres (CPCs), conforming to GMP. Since this system satisfies the requirements of regulations in Japan and the USA for electronic records and electronic signatures (ER/ES), the use of ER/ES has been allowed, and the risk of contamination resulting from the use of recording paper has been eliminated, thanks to paperless operations within the CPC. Moreover, to reduce the risk of mix-up and cross-contamination due to contact during production, we developed a touchless input device with built-in radio frequency identification (RFID) reader-writer devices and optical sensors. The use of this system reduced the time to prepare and issue manufacturing instructions by 50% or more, compared to the conventional handwritten system. The system contributes to producing more large-scale production and to reducing production costs for cell and tissue products in regenerative medicine. Copyright © 2014 John Wiley & Sons, Ltd.
DOI	10.1002/term.1869
PMID	24700532