The
pluripotent nature of
human embryonic stem cells (hESC) makes them very attractive as a source of various cell types that could be used therapeutically in
regenerative medicine. However, eliminating all sources of contamination, animal-derived or human cell-derived, during hESC derivation and propagation is necessary before hESC derivatives can be used clinically. Although there is continuing progress toward this goal, none of the methods to date to produce hESC lines under
good manufacturing practices (GMP) has been published. The long-term success for GMP compliance depends critically on maintaining and implementing a stringent
quality control system which is also dictated by the regulatory authorities in different countries. In this unit, an approach is described based upon the experience of this author and others towards achieving clinical-grade hESC lines systematically involving all the steps from start to finish under GMP environment. This unit provides a basic layout for GMP set up to achieve
quality controls, a step-by-step guide to producing new hESC lines under defined conditions, and
standard operating procedures used to achieve this outcome. Curr. Protoc.
Stem Cell Biol. 6:1A.4.1-1A.4.31. (c) 2008 by John Wiley & Sons, Inc.
