Research & Development Center for Cell TherapyResearch for cell manufacturing process

Research for cell manufacturing process

Complicated work for operators in CPC today

SCP Solves the major challenges with manual production

Chance of contamination by open culture system

Automated closed cell culture system with ER/ES

Insufficient monitoring

Introduction of process monitoring by process analytical technology (PAT)

High Variability of raw materials and process inconsistency

Introduction of concept of Risk management in ICH Q trio

Inadequate quality control and product release criteria

Paradigm shift to from QbT to QbD and new production control solution

Huge cost for product

Reduce cost by QbD and new control solution

Development of Smart Cell Processing (SCP) that solves the hurdles

SCP system configuration Development of in-line Holographic Microscopy

SCP system configuration Development of In-process monitorin

SCP System configuration medium analysis by LC-MS/MS

SCP system configuration

Development of data integration system by IT solution

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