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.
authors.affiliation: Roslin Cells Limited, Nine Edinburgh Bio-Quarter, 9 Little France Road, Edinburgh EH16 4UX, UK; Centre for Clinical Brain Sciences, University of Edinburgh, Chancellors Building, 49 Little France Crescent, Edinburgh EH16 4SB, UK; MRC Centre for Regenerative Medicine, University of Edinburgh, 5 Little France Drive, Edinburgh, Scotland EH16 4UU, UK. Electronic address: paul.desousa@ed.ac.uk.
authors.forename: P A
authors.initials: PA
authors.lastname: De Sousa
authors.affiliation: Roslin Cells Limited, Nine Edinburgh Bio-Quarter, 9 Little France Road, Edinburgh EH16 4UX, UK.
authors.forename: J M
authors.initials: JM
authors.lastname: Downie
authors.affiliation: Roslin Cells Limited, Nine Edinburgh Bio-Quarter, 9 Little France Road, Edinburgh EH16 4UX, UK.
authors.forename: B J
authors.initials: BJ
authors.lastname: Tye
authors.affiliation: Roslin Cells Limited, Nine Edinburgh Bio-Quarter, 9 Little France Road, Edinburgh EH16 4UX, UK.
authors.forename: K
authors.initials: K
authors.lastname: Bruce
authors.affiliation: Roslin Cells Limited, Nine Edinburgh Bio-Quarter, 9 Little France Road, Edinburgh EH16 4UX, UK.
authors.forename: P
authors.initials: P
authors.lastname: Dand
authors.affiliation: Centre for PGD, Institute for Women's Health, University College London, WC1E 6HX, UK.
authors.forename: S
authors.initials: S
authors.lastname: Dhanjal
authors.affiliation: Centre for Reproductive and Genetic Health, 230-232 Great Portland Street, London, W1W 5QS, UK.
authors.forename: P
authors.initials: P
authors.lastname: Serhal
authors.affiliation: Centre for PGD, Institute for Women's Health, University College London, WC1E 6HX, UK.
authors.forename: J
authors.initials: J
authors.lastname: Harper
authors.affiliation: Scottish National Blood Transfusion Service, 21 Ellen's Glen Rd, Edinburgh EH17 7QT, UK.
authors.forename: M
authors.initials: M
authors.lastname: Turner
authors.affiliation: Roslin Cells Limited, Nine Edinburgh Bio-Quarter, 9 Little France Road, Edinburgh EH16 4UX, UK.
authors.forename: M
authors.initials: M
authors.lastname: Bateman
mesh_terms: D018929:Cell Culture Techniques / Q000592:standards*; D002454:Cell Differentiation; D002478:Cells, Cultured; D033161:Government Regulation; D000066449:Human Embryonic Stem Cells / Q000166:cytology*; D006801:Humans; D011786:Quality Control