Development and production of good manufacturing practice grade human embryonic stem cell lines as source material for clinical application

被引:28
作者
De Sousa, P. A. [1 ,2 ,3 ]
Downie, J. M. [1 ]
Tye, B. J. [1 ]
Bruce, K. [1 ]
Dand, P. [1 ]
Dhanjal, S. [4 ]
Serhal, P. [6 ]
Harper, J. [4 ]
Turner, M. [5 ]
Bateman, M. [1 ]
机构
[1] Roslin Cells Ltd, Nine Edinburgh Bioquarter,9 Little France Rd, Edinburgh EH16 4UX, Midlothian, Scotland
[2] Univ Edinburgh, Ctr Clin Brain Sci, Chancellors Bldg,49 Little France Crescent, Edinburgh EH16 4SB, Midlothian, Scotland
[3] Univ Edinburgh, MRC Ctr Regenerat Med, 5 Little France Dr, Edinburgh EH16 4UU, Midlothian, Scotland
[4] UCL, Inst Womens Hlth, Ctr PGD, London WC1E 6HX, England
[5] Scottish Natl Blood Transfus Serv, 21 Ellens Glen Rd, Edinburgh EH17 7QT, Midlothian, Scotland
[6] Ctr Reprod & Genet Hlth, 230-232 Great Portland St, London W1W 5QS, England
基金
英国惠康基金;
关键词
DERIVATION; CULTURE;
D O I
10.1016/j.scr.2016.08.011
中图分类号
Q813 [细胞工程];
学科分类号
摘要
From 2006 to 2011, Roslin Cells Ltd derived 17 human embryonic stemcells (hESC) while developing (RCM1, RC-2 to -8, -10) and implementing (RC-9, -11 to -17) quality assured standards of operation in a facility operating in compliance with European Union (EU) directives and United Kingdom(UK) licensure for procurement, processing and storage of human cells as source material for clinical application, and targeted to comply with an EU Good Manufacturing Practice specification. Here we describe the evolution and specification of the facility, its operation and outputs, complementing hESC resource details communicated in Stem Cell Research Lab Resources. (C) 2016 Published by Elsevier B.V.
引用
收藏
页码:379 / 390
页数:12
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