BioTime, Inc. a biotechnology company that develops and markets products in the field of regenerative medicine, announced that two human Embryonic Stem (hES) cell lines, ESI-014 and ESI-017, developed by a BioTime subsidiary have been approved by the National Institutes of Health (NIH) for inclusion in the NIH Human Embryonic Stem Cell Registry. This approval opens the door to the use of these cell lines in Federally funded research. To BioTime's knowledge, these are the first such cell lines approved for Federal funding that were derived under conditions designed to be compliant with current Good Manufacturing Practices (cGMP) for human clinical use.
“This approval is key to our strategy of making our bank of GMP-compliant hES cell lines the industry standard for the development of a wide array of new human therapeutic products,” said Michael D West, PhD, president and CEO of BioTime. “We believe our ESI hES cell lines are the best characterized and documented lines available today. Our clinical grade hES cell lines were derived using procedures and documentation that are in compliance with current Good Tissue Practices (cGTP) and cGMP, which we believe will facilitate the transition of therapeutic products derived by researchers from these cell lines from laboratory to clinical use. We're grateful the NIH has approved the use of ESI-014 and ESI-017 and we look forward to working with researchers to translate the science into commercially successful therapeutic products.”
The NIH created the Human Embryonic Stem Cell Registry in 2001 in order to facilitate research using human embryonic stem cells. The registry now includes hES cell lines that meet certain eligibility criteria including ethical derivation and informed consent. Only research projects using hES cell lines listed in the Registry are eligible for Federal funding.
ESI-014 and ESI-017 were developed by ES Cell International Pte. Ltd. (ESI), a wholly owned subsidiary of BioTime. ESI is one of the earliest pioneers of human embryonic stem cell technology. The ESI hES cell lines were produced free of animal feeder cells, are fully characterized, and have been assessed for pluripotency and karyotypic stability. As part of a collaboration with the California Institute of Regenerative Medicine (CIRM), BioTime has supplied research grade versions of the cells to dozens of researchers throughout California, including researchers at universities that are part of the University of California system.
BioTime has agreed to provide a complete genome sequence to these collaborators by the Fall of 2011 to facilitate future human use of products derived from these cell lines. BioTime expects to seek NIH approval of ESI's other GMP-compliant hES cell lines, which have also been provided to CIRM-funded researchers. Another ESI cell line is being evaluated by a large pharmaceutical company for potential use in its product development programme.
BioTime, a biotechnology company focused on regenerative medicine and blood plasma volume expanders. It develops and markets research products in the field of stem cells and regenerative medicine, including a wide array of proprietary ACTCellerate cell lines, culture media, and differentiation kits.