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

doi:10.1016/j.scr.2016.08.011

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

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

Abstract / Description of output

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 language	English
Pages (from-to)	379-390
Number of pages	12
Journal	Stem Cell Research
Volume	17
Issue number	2
Early online date	26 Aug 2016
DOIs	https://doi.org/10.1016/j.scr.2016.08.011
Publication status	Published - 1 Sept 2016

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10.1016/j.scr.2016.08.011

De Sousa P Development and production
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title = "Development and production of good manufacturing practice grade human embryonic stem cell lines as source material for clinical application",

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.",

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AU - De Sousa, P. A.

AU - Downie, J. M.

AU - Tye, B. J.

AU - Bruce, K.

AU - Dand, P.

AU - Dhanjal, S.

AU - Serhal, P.

AU - Harper, J.

AU - Turner, M.

AU - Bateman, M.

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

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

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