4.2 Article

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

Journal

STEM CELL RESEARCH
Volume 17, Issue 2, Pages 379-390

Publisher

ELSEVIER SCIENCE BV
DOI: 10.1016/j.scr.2016.08.011

Keywords

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Funding

  1. Scottish Enterprise Economic Development Agency [PM07321]
  2. Wellcome Trust [130810]

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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.

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