International Stem Cell (ISC) has reported that its new cell production facility in Oceanside, California has passed final building inspection, which will enable development and manufacturing of the company and its partners' clinical-grade stem cell products.
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ISC’s facility consists of separate suites for development and production of different cell types from the company’s proprietary human parthenogenic stem cell (hpSC) technology.
The company has established the facility in close proximity to the fertility clinics that provide donated human eggs (oocytes), under it’s recently-established partnerships. It is also near to the Californian research institutions with whom ISC collaborates on fundamental stem cell biology and therapeutic applications.
ISC is expected to implement its parthenogenic stem cell processes at this facility during 2010, and adopt current good manufacturing practice (cGMP) standards. In parallel, the company will collaborate with scientists to demonstrate the therapeutic applicability and the potential immune-rejection advantages of hpSC lines relative to other stem cell classes.
Andrey Semechkin, CEO of International Stem Cell, said: “Our ability to work in this modern facility gives ISCO 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.”
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