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

P. A. De Sousa, J. M. Downie, B. J. Tye, K. Bruce, P. Dand, S. Dhanjal, P. Serhal, J. Harper, M. Turner, M. Bateman

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish
Pages (from-to)379-390
Number of pages12
JournalStem Cell Research
Volume17
Issue number2
Early online date26 Aug 2016
DOIs
Publication statusPublished - 1 Sep 2016

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