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

- Development and implementation of GMP hESC derivation & banking capability
- Methods culminating in non-GMP and GMP hESC lines published in SCR Lab Resources
- Compliance with EU Directives, UK licensure and US Guidance for GMP manufacture
- HESC lines suitable as source material for clinical applications

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.