This article appears in the following Human Molecular Genetics issue: Stem Cells and Regeneration [View the issue table of contents]
Good manufacturing practice and clinical-grade human embryonic stem cell lines
1 Department of Medicine and 2 Department of Clinical Science, Intervention and Technology, Karolinska Institutet and 3 Vecura, Clinical Research Center, Karolinska University Hospital Huddinge, SE-14186 Stockholm, Sweden 4 Regea, Institute of Regenerative Medicine, University of Tampere and Tampere University Hospital, FI-33014 Tampere, Finland
* To whom correspondence should be addressed. Tel: +46 858583858; Fax: +46 858587575; Email: outi.hovatta{at}ki.se
Received January 30, 2008; Revised February 12, 2008; Accepted March 6, 2008
Human embryonic stem cell (hESC) lines, after directed differentiation, hold the greatest potential for cell transplantation treatment in many severe diseases. Good manufacturing practice (GMP) quality, defined by both the European Medicines Agency and the Food and Drug Administration, is a requirement for clinical-grade cells, offering optimal defined quality and safety in cell transplantation. Using animal substance-free culture media, feeder cells or feeder-free matrix in derivation, passaging, expansion and cryopreservation procedures, immune reactions against animal proteins in the cells, and infection risk caused by animal microbes can be avoided. It is also possible to apply GMP to animal components if no better options are available. In recent production of GMP-quality hESC lines, feeder cells had been cultured in fetal bovine serum, and the medium supplemented with an animal protein containing a serum replacement component. Using embryos cultured in a GMP laboratory, isolating the inner cell mass mechanically, deriving lines on human feeder cells originally cultured in xeno-free medium in a GMP laboratory, and using xeno-free media for derivation and culture of hESC lines themselves, GMP-quality xeno-free hESC lines could be established today. Human serum is a xeno-free component available today, but many chemically defined media are under development.
These authors contributed equally to this work.
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