Considering Cell Therapy Product "Good Manufacturing Practice" Status

被引:34
作者
Bedford, Patrick [1 ]
Jy, Juliana [1 ]
Collins, Lucas [1 ]
Keizer, Steven [1 ]
机构
[1] CCRM, Toronto, ON, Canada
关键词
cell therapy; clinical trials; regulatory; manufacturing; good manufacturing practices; international perspective;
D O I
10.3389/fmed.2018.00118
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
引用
收藏
页数:4
相关论文
共 6 条
[1]  
[Anonymous], 2015, HLTH CANADA GUIDANCE
[2]  
George Bobby, 2011, Perspect Clin Res, V2, P94, DOI 10.4103/2229-3485.83228
[3]   Clinical development of CAR T cells-challenges and opportunities in translating innovative treatment concepts [J].
Hartmann, Jessica ;
Schuessler-Lenz, Martina ;
Bondanza, Attilio ;
Buchholz, Christian J. .
EMBO MOLECULAR MEDICINE, 2017, 9 (09) :1183-1197
[4]   Uncertainty and innovation: Understanding the role of cell-based manufacturing facilities in shaping regulatory and commercialization environments [J].
Isasi, Rosario ;
Rahimzadeh, Vasiliki ;
Charlebois, Kathleen .
APPLIED AND TRANSLATIONAL GENOMICS, 2016, 11 :27-39
[5]   Clinical translation and regulatory aspects of CAR/TCR-based adoptive cell therapies-the German Cancer Consortium approach [J].
Krackhardt, Angela M. ;
Anliker, Brigitte ;
Hildebrandt, Martin ;
Bachmann, Michael ;
Eichmueller, Stefan B. ;
Nettelbeck, Dirk M. ;
Renner, Matthias ;
Uharek, Lutz ;
Willimsky, Gerald ;
Schmitt, Michael ;
Wels, Winfried S. ;
Schuessler-Lenz, Martina .
CANCER IMMUNOLOGY IMMUNOTHERAPY, 2018, 67 (04) :513-523
[6]   Regulatory approval for autologous human cells and tissue products in the United States, the European Union, and Japan [J].
Yano, Kazuo ;
Watanabe, Natsumi ;
Tsuyuki, Kenichiro ;
Ikawa, Taisuke ;
Kasanuki, Hiroshi ;
Yamato, Masayuki .
REGENERATIVE THERAPY, 2015, 1 :45-56