
The partners said that they intend to establish a bank of Good Manufacturing Practice-grade human embryonic stem cell lines with Advanced cell's "single-ceblastomere" technique for deriving embryonic stem cells without damage to the embryo.
“Until we developed our single blastomere technology,
embryonic stem cell research had been synonymous with the destruction of human embryos,” stated Robert Lanza, MD, ACT CSO.
“In stark contrast to embryonic stem cells lines currently available for research, such as those on the NIH registry, our single blastomere technique does not destroy the embryo. One of the benefits to an ability to create new hESC lines without destroying embryos is that it addresses ethical concerns of certain researchers.”
ACT's single blastomere technique relies on isolating a single cell from a 4 to 8 cell embryo utilising a one-cell biopsy approach similar to that used in pre-implantation genetic diagnostics (PGD). According to recent literature, one-cell biopsy as part of PGD is carried out routinely around the world, and one to two thousand children are born every year in the United States and Europe after being conceived by in vitro fertilization using one-cell biopsy and PGD.
Cell lines will be created and stored using protocols that meet regulations of both the European Medicines Agency and the US Food and Drug Administration, according to Marlborough, Mass.-based Advanced Cell.
Scotland-based Roslin Cells will be responsible for maintaining the banked hESC lines, which will be made available for both research and commercial purposes. It will also promote access to the hESC lines from the bank as research reagents to both academic and commercial entities.
The partners plan to publish a commercialisation license "so that third parties will have a reasonable, predictable path to commercialisation of products using the same hESC lines that they may use in animal model studies for preclinical data," the firms said in the statement.
Proceeds from licenses will be shared by Advanced Cell and Roslin Cells but financial details of the agreement were not disclosed.
"Through the creation of hESC lines derived using our proprietary 'embryo-safe' technique, we fully expect Roslin Cells to quickly become a leading hESC bank for Europe, North America, and Asia," Advanced Cell interim chairman and CEO Gary Rabin said. "We foresee major demand for these embryonic stem cells from both researchers and commercial interests across the globe."