Feb 5 2010
International Stem Cell Corporation (OTCBB:ISCO),
www.internationalstemcell.com,
announced today that its new cell production facility has passed final
building inspection, which will enable development and manufacturing of
the company and its partners’ clinical-grade stem cell products.
ISCO has designed and built a unique cell manufacturing facility in
Oceanside, California consisting of separate “suites” for development
and production of different cell types from the company’s proprietary
human parthenogenic stem cell (hpSC) technology. The facility is located
in close proximity to the fertility clinics that provide donated human
eggs (oocytes) under ISCO’s recently-established partnerships and also
near leading Californian research institutions with whom ISCO
collaborates on fundamental stem cell biology and therapeutic
applications.
ISCO will implement its parthenogenic stem cell processes at this
facility during 2010 and adopt current good manufacturing practice
(cGMP) standards. In parallel, ISCO will collaborate with world-leading
scientists to demonstrate the therapeutic applicability and the
potential immune-rejection advantages of hpSC lines relative to other
stem cell classes.
Like embryonic stem cells (ESCs), hpSCs are pluripotent (i.e. have the
capacity to become almost any cell type in the body), yet avoid ethical
issues associated with destruction or use of viable human embryos.
Unlike induced pluripotent stem cells (iPSs), hpSCs do not require
manipulation of gene expression back to a less differentiated stage,
which may prove to be a safety or regulatory obstacle. However, unlike
both ESCs and iPSs, hpSCs can be created in a homozygous form such that
each line can be an immunological match for millions of patients.
Dr. Andrey Semechkin, ISCO’s CEO, says: “Our ability to work in this
modern facility gives International Stem Cell Corporation the capacity
to generate the world’s first cGMP quality hpSC lines. It marks an
important milestone since it both expands the resources available to our
scientists and expands ISCO’s ability to execute on its plan to become
the premier provider of immune-matched stem cells to the global research
community. Through these cells, ISCO will be able to treat a range of
degenerative diseases in genetically diverse populations around the
world.”
SOURCE International Stem Cell Corporation