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

Stem Cell Res. 2016 Sep;17(2):379-390. doi: 10.1016/j.scr.2016.08.011. Epub 2016 Aug 26.

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.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Cell Culture Techniques / standards*
  • Cell Differentiation
  • Cells, Cultured
  • Government Regulation
  • Human Embryonic Stem Cells / cytology*
  • Humans
  • Quality Control