Cleveland, Ohio-based Athersys, Inc. said on February 28 that it has successfully produced a clinical grade master cell bank and initial product doses intended to support its clinical trial activity in 2007 and 2008.
The master cell bank and dose production runs were completed under Good Manufacturing Practices (GMP) by Lonza, a contract manufacturer of biopharmaceuticals headquartered in Basel, Switzerland.
MultiStem is a multipotent adult progenitor cell (MAPC)-based product manufactured under Athersys’s specifications and release criteria.
MultiStem are stem cells isolated from the bone marrow and other non-embryonic tissue sources that have the potential to develop into a range of cell types and can be expanded extensively ex vivo while retaining their potency.
Dr. Catherine Verfaillie and her colleagues initially discovered and characterized these stem cells, as described in a series of publications in leading scientific journals.
Since then, a growing number of labs around the world have isolated and characterized non-embryonic stem cells that display the fundamental properties described by Verfaillie and her colleagues.
“We view GMP production as an important milestone for Athersys, and for the advancement of MAPC-based products in the clinic,” said Athersys president B.J. Lehmann. “This achievement further demonstrates that we can readily transfer the cell isolation and production processes to third parties. Additionally, we believe that our master cell bank gives us the potential to manufacture hundreds of thousands or more MultiStem doses from a single donor, enabling us to advance multiple programs into clinical development, and treat patients with a variety of conditions.”
Athersys has completed multiple animal studies demonstrating that MultiStem can be safely infused and provides significant benefit in a number of disease models.
The company is developing MultiStem to treat patients for certain cardiovascular disorders, stroke, bone marrow transplantation and oncology support, as well as other disease indications.
Contact: http://www.lonza.com
Contact: B.J. Lehmann, 216-431-9900, bjlehmann@athersys.com
