Derivation of embryonic stem cell lines in GMP conditions – a protocol

by Alexey Bersenev on June 25, 2012 · 0 comments

in cell product, embryonic/iPS, protocols

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Regulatory agencies put a big emphasis on GMP-grade xeno-free production of cellular products for clinical use. Currently, the most of embryonic stem cell-derived lines have been produced with use of animal components. Nature Protocols published an open access protocol for GMP-grade derivation of embryonic stem cell lines:

… it is worth bearing in mind that neither of the reported trials used hES cells derived a priori under current GMP (cGMP) conditions; rather they used those that were reclassified at great expense from research grade lines.

It is our opinion that xeno-free (XF) lines should be used for clinical trials. The only hES cell lines derived ab initio for clinical use were made in Singapore from embryos imported from Australia, and they were derived in the presence of animal products. These lines are now distributed at minimal cost to California-based researchers by BioTime…

Also watch related video (a look inside of GMP-suite!)
Also look at earlier publication of Dusko Ilic’s group.

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