細胞療法研究開発センター細胞製造工程に関する研究開発
細胞製造工程に関する研究開発
開発の背景
抽出された課題とその解決策
手作業・開放系培養でのコンタミの危険性の存在
自動化閉鎖系培養systemの導入
製造工程中の不十分な品質検査
製造工程中のリアルタイム品質管理モニタリングsystemの導入、ER/ES format
ER/ES：電磁的記録及び電子署名
出発原材料(細胞)や生物由来原料の品質・規格の揺らぎやそれに起因する工程の変
ICH Q TrioにあるRA, RM, DS, in-process monitoringの導入
RA：Risk Assessment, RM: Risk Management, DS : design space
膨大な製造コスト
製品のトレースが可能となる製造,品質,人員,購入,運営管理system導入
-IT based-細胞製造情報統合ソフトの開発-
抽出課題を解決するSmart Cell Processing （SCP) の開発
SCP system configuration In-line Holographic Microscopyの開発・導入
SCP system configuration In-process monitoringの開発・導入
SCP System configuration 培地解析 by LC-MS/MS
SCP system configuration
製造施設・製造工程統合管理システムの開発
FY2015-FY2017 Publication list
Differentiation potential of Pluripotent Stem Cells correlates to the level of CHD7
Takako Yamamoto, Chiemi Takenaka, Yasuhiro Ohshima, Yusuke Yoda, Kenichi Kagawa, Shin Kawamata、Scientific Reports 2018 Jan 10;8(1):241.
A defined culture method enabling the establishment of ring sideroblasts from
induced pluripotent cells of X-linked sideroblastic anemia. Shunsuke Hatta, Tohru Fujiwara, Takako Yamamoto, Kei Saito, Mayumi Kamata, Yoshiko Tamai, Shin Kawamata and Hideo Harigae Hematologica 2018 Jan in press
Identification of a Gene Encoding Slow Skeletal Muscle Troponin T as a Novel Marker for Immortalization of Retinal Pigment Epithelial Cells. Takuya Kuroda, Satoshi Yasuda, Hiroyuki Nakashima, Nozomi Takada, Satoko Matsuyama, Shinji Kusakawa, Akihiro Umezawa, Akifumi Matsuyama, Shin Kawamata, and Yoji Sato, Scientific Reports 2017 Aug 15;7(1):8163. doi: 10.1038/s41598-017-08014-w
Report of the International Stem Cell Banking Initiative Workshop Activity: Current Hurdles and Progress in Seed-stock Banking of Human Pluripotent Stem Cells. Jung-Hyun Kim, Andreas Kurtz, Bao-Zhu Yuan, Fanyi Zeng, Geoff Lomax, Jeanne F. Loring, Jeremy Crook, Ji Hyeon Ju, Laura Clarke, Maneesha S. Inamdar, Martin Pera, Meri Firp, Michael Sheldon, Nafees Rahman, Orla O’Shea, Patricia Pranke, Qi Zhou, Rosario Isasi, Ruttachuk Rungsiwiwut, Shin Kawamata, Steve Oh, Tennielle Ludwig, Tohru Masui, Tom Novak, Tsuneo Takahashi, Wataru Fujibuchi, Soo Kyung Koo, Glyn N Stacey. Stem Cell Translational Medicine 2017 (in press)
Autologous Induced Stem-Cell-Derived Retinal Cells foe Macular Degeneration Mandai M, Watanabe A, Kurimoto Y, Hirami Y, Morinaga C, Daimon T, Fujihara M, Akimaru H, Sakai N, Shibata Y, Terada M, Nomiya Y, Tanishima S, Nakamura M, Kamao H, Sugita S, Onishi A, Ito T, Fujita K, Kawamata S, Go MJ, Shinohara C, Hata KI, Sawada M, Yamamoto M, Ohta S, Ohara Y, Yoshida K, Kuwahara J, Kitano Y, Amano N, Umekage M, Kitaoka F, Tanaka A, Okada C, Takasu N, Ogawa S, Yamanaka S, Takahashi M. N Engl J Med. 2017 16;376(11):1038-1046
Report of the International Regulatory Forum on Human Cell Therapy and Gene Therapy Products. Hayakawa T, Harris I, Joung J, Kanai N, Kawamata S, Kellathur S, Koga J, Lin YC, Maruyama Y, McBlane J, Nishimura T, Renner M, Ridgway A, Salmikangas P, Sakamoto N, Sato D, Sato Y, Toda Y, Umezawa A, Werner M, Wicks S. Biologicals 2016 44, 476-479
Ultra-sensitive detection of tumorigenic cellular impurities in human cell-processed therapeutic products by digital analysis of soft agar colony formation. Shinji Kusakawa, Satoshi Yasuda, Takayuki Kuroda, Shin Kawamata and Yoji Sato, 2015 Science Reports| 5:17892|DOI:10.1038/Srep 17892
A Simple and Efficient Method of Slow Freezing for Human Embryonic Stem Cells and Induced Pluripotent Stem Cells. Keitaro Imaizumi, Momoe Iha, Naoki Nishishita, Shin Kawamata, Shinichi Nishikawa, Teruo Akuta Methods in Molecular Biology DOI 10.1007/7651_2015_211 Springer Science+Business Media, New York, 2015
Controlled Growth and the Maintenance of Human Pluripotent Stem Cells by Cultivation with Defined Medium on Extracellular Matrix-Coated Micropatterned Dishes. Chiemi Takenaka, Hiroshi Miyajima, Yusuke Yoda, Hideo Imazato, Takako Yamamoto, Shinichi Gomi, Yasuhiro Ohshima, Kenichi Kagawa, Tetsuji Sasaki, Shin Kawamata PLoS ONE | DOI:10.1371/journal.pone.0129855 June 26, 2015
Human Gingival Integration-Free iPSCs; a Source for MSC-Like Cells. Yasuyuki Umezaki, Yoshiya Hashimoto, Naoki Nishishita, Shin Kawamata, Shunsuke Baba International Journal of Molecular Sciences 2015, 16 (6): 13633-48
Protective effects of human iPS-derived retinal pigmented epithelial cells in comparison with human mesenchymal stromal cells and human neural stem cells on the degenerating retina in rd1 mice. Sun J, Mandai M, Kamao H, Hashiguchi T, Shikamura M, Kawamata S, Sugita S, Takahashi M. Stem Cells. 2015 May 33(5):1543-53. doi: 10.1002/stem.1960
Speech and lectures at international symposium and meetings in 2017
Annual meeting International Society of Stem Cell Banking Initiative, Boston, USA in June 2017
Annual meeting International Society Stem Cell Initiative, in Sheffield, UK in October 2017
4th African Genetic Human Society, in Cairo, Egypt in November 2017