Advanced Cell Technology and Roslin Cells collaborate to produce
embryonic stem cells
7 Jan 2011
Advanced Cell Technology Inc and Scottish company Roslin Cells
Ltd have agreed to collaborate to establish a bank of GMP-grade human
embryonic stem cell (hESC) lines using ACT’s proprietary 'single-ceblastomere'
technique for deriving embryonic stem cells without damage to the
The collaboration contemplates that the hESC lines will be
created and stored using protocols that meet the regulatory
standards of the European Medicines Agency (EMA) and US FDA.
Roslin Cells, which is an offshoot of the Roslin Institute, will
be responsible for maintaining the banked hESC lines, which will be
made available for both research and commercial purposes. By
utilizing GMP and careful characterization and documentation of the
resulting hESC lines, it is intended that the banked hESC lines will
be suitable to move readily from laboratory settings into clinic
programs, thereby speeding translation research into human
treatments. Predictability in price and commercialization terms is a
key feature of the goals of the collaboration.
Roslin Cells will promote access to the hESC lines from the bank
as research reagents to both academic and commercial entities. In
addition, ACT and Roslin Cells will publish a commercialization
license so that third parties will have a reasonable and predictable
path to commercialization of products using the same hESC lines that
they may use in animal model studies for preclinical data.
Commercialization licenses will also provide access to the cell
lines biologics master file in order to establish regulatory
compliance. Proceeds from commercialization licenses, including
milestone and royalty payments, will be shared between ACT and
“The relationship with Roslin Cells has grown out of our
initiatives in Europe over the past year, and comes as part of our
close efforts with the Scottish Development agency. Along with the
recent announcement of our European Orphan drug designation filing
in our Stargardt’s disease treatment program, the relationship with
Roslin Cells signals the expansion of our commercial initiatives in
Europe, and, more broadly, markets around the world,” said ACT’s
Interim Chairman and CEO, Gary Rabin.
“Roslin Cells is already one of the leading organizations in GMP
manufacturing of stem cells. 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. We foresee major demand for these
embryonic stem cells from both researchers and commercial interests
across the globe.”
“Until we developed our single blastomere technology, embryonic
stem cell research had been synonymous with the destruction of human
embryos,” stated Robert Lanza, MD, Chief Scientific Officer at ACT.
“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
The Company’s single blastomere technique relies on isolating a
single cell from a 4 to 8 cell embryo utilizing 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.
“The availability of our ‘embryo safe’ hESC lines has sparked
interest in many quarters, including at institutions that have been
opposed to conducting embryonic stem cell research in the past,”
continued Dr. Lanza. “We are exploring opportunities to provide our
cells to those institutions.