ISCO’s stem cell manufacturing facility has passed final building inspection, enabling it to implement the processes and cGMP standards needed to produce clinical-grade products.
Pharma’s interest in the potential of stem cell therapies continues to grow, despite ethical objections from some groups, and researchers will now have access to a source of human parthenogenic stem cells (hpSC).
International Stem Cell Corporation (ISCO) believes its proprietary hpSCs avoid some of the ethical concerns, because they use unfertilised oocytes, and will have less significant safety and regulatory hurdles than alternatives.
To meet demand for hpSCs ISCO is building a facility in Oceanside, California, US. The site houses separate suites for development and production of different cell types from ISCO’s hpSC technology.
Having passed final building inspection ISCO will begin implementing its parthenogenic stem cell processes at the facility and adopt current good manufacturing practices (cGMP).
In parallel, ISCO will collaborate with scientists to demonstrate the therapeutic potential and immune-rejection advantages of hpSC lines compared to alternative stem cell classes.
ISCO has partnerships with various universities and companies, including Novocell, a California-based company that is developing treatments for diabetes and other chronic diseases.
The company’s wholly-owned subsidiary, Lifeline Cell Technology, also has manufacturing and distribution partnerships with Millipore, Invitrogen and Cell Systems Biotechnologie Vertrieb.
ISCO believes that its hpSCs have benefits over embryonic, induced pluripotent (iPS) or adult stem cells which minimise the likelihood of ethical, safety and regulatory concerns.
hpSCs are derived from parthenogenetically activated human oocytes. Parthenogenesis is a form of asexual reproduction and by removing the need for fertilisation ISCO expects to avoid ethical opposition.
Furthermore, hpSCs are produced without the need for forced change of gene expression systems and consequently will face fewer safety and regulatory hurdles than iPS, according to ISCO.