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ESI Announces Production of Clinically-Compliant Human Embryonic Stem Cell
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ES Cell International Pte Limited (ESI) has announced the production and banking of four clinically-compliant human embryonic stem cell (hESC) lines – i.e. stem cell lines made under conditions of current Good Manufacturing Practice, highlighted in an edition of the journal Nature.
Another four lines should be banked within the next four to five weeks. To ESI’s knowledge, no other group in the world has derived hESC lines to cGMP standards and is willing to make them available to the research community.
ESI intends to distribute research-grade versions of the cells to academic researchers worldwide through the ASTAR Singapore Stem Cell Consortium (SSCC).
The SSCC Stem Cell Bank will be responsible for growing up the cells under non-cGMP conditions for distribution, around the end of this year, to academic researchers at a modest cost without IP reach-through.
This development will facilitate laboratory research whilst allowing users the option of later securing from ESI the clinically-compliant versions of exactly the same cell lines that they are using for their research.
Commenting on the announcement, Dr Alan Colman, CEO of ESI, said, "We are very excited about this development, which has tremendous implications for the research with hESCs as a source of new cell therapies in the future."
"We hope the take-up rate of the research-grade material will be high, as researchers should be encouraged by the prospect of a simpler transition of hESC-based cell therapy applications from the laboratory to the clinic."
ESI will retain direct control over the distribution of the cGMP-grade, master cell bank samples, as well as over any distribution to commercial entities.
Using ESI protocols, all the lines have been derived from blastocyst embryos by stem cell scientists from Sydney IVF Limited, Australia and ESI, Singapore, at Q-Gen Pty Limited, a GMP facility in Brisbane, Australia.
The embryos, all frozen for over two years at Sydney IVF, were donated with full informed consent after stringent donor screening and testing.
These derivations incorporated the use of cGMP-qualified human adult feeder cells that are also currently being used for therapeutic purposes in the US.
