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),908-915頁
著者・共著者 IWAYAMA Daisuke†, YAMATO Masayuki, TSUBOKURA Tetsuya, TAKAHASHI Minoru, OKANO Teruo*
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