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

De Sousa, PA; Downie, JM; Tye, BJ; Bruce, K; Dand, P; Dhanjal, S; Serhal, P; ... Bateman, M; + view all (2016) Development and production of good manufacturing practice grade human embryonic stem cell lines as source material for clinical application. Stem Cell Research , 17 (2) pp. 379-390. 10.1016/j.scr.2016.08.011. Green open access

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Abstract

From 2006 to 2011, Roslin Cells Ltd derived 17 human embryonic stem cells (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.

Type: Article
Title: Development and production of good manufacturing practice grade human embryonic stem cell lines as source material for clinical application
Open access status: An open access version is available from UCL Discovery
DOI: 10.1016/j.scr.2016.08.011
Publisher version: https://doi.org/10.1016/j.scr.2016.08.011
Language: English
Additional information: © Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
Keywords: Science & Technology, Life Sciences & Biomedicine, Cell & Tissue Engineering, Biotechnology & Applied Microbiology, Cell Biology, DERIVATION, CULTURE
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > UCL EGA Institute for Womens Health
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > UCL EGA Institute for Womens Health > Reproductive Health
URI: https://discovery.ucl.ac.uk/id/eprint/10050806
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