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Thursday, March 29, 2007 10:06:21 AM
Pluristem Upgrading Its Manufacturing Facility to Support $200 Million in Production Capacity for PLX - I
Thursday March 29, 8:30 AM EDT
NEW YORK, Mar 29, 2007 (BUSINESS WIRE) -- Pluristem Life Systems, Inc. (PLRS), a cell therapy Company dedicated to the commercialization of cell therapy products for a variety of indications, has announced it will upgrade and enlarge its existing manufacturing facility to Support $200 Million in Production Capacity for PLX - I. The additional 6,900 square foot will double in size the Company's facilities and is expected to be ready this summer. This facility will manufacture PLX-I, the Company's introductory product to address the bone marrow transplant market, for Phase I clinical trials and large scale commercial production.
Zami Aberman, Pluristem CEO, stated: "We continue to execute our strategy of controlling the entire commercialization process, from harvesting placenta cells and umbilical cord blood to product development and expansion, and product sales. We anticipate completion of the new facilities and GMP (Good Manufacturing Practice) certification prior to the initiation of Phase I clinical trials, planned to begin during 2007." The Company intends to commercialize PLX-I and several prospective cell therapy products in the United States as well as the rest of the world.
Once complete, Pluristem's initial annual production capacity for its proprietary PLX (PLacenta eXpanded) cells will be approximately 14,000 doses of PLX-I per year with an estimated value of $200 million. Pluristem is spending about $500,000 to lease additional space adjacent to its current facilities, adding bioreactors, support equipment and other infrastructure improvements.
Mr. Aberman added, "We are able to increase the production capability of this new facility by another 300% very quickly. This enables us to scale our production as we gain market share and still keep our expenses under control."
Pluristem is in the process of implementing GMP controls to provide a reliable quality assurance environment per US Food and Drug Administration (FDA) requirements. These requirements call for process and organizational controls to ensure authenticity, integrity and confidentiality for all product records from design, manufacture, testing, packing, storage and other product development processes.
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