HAIFA, Israel, Oct. 23, 2012 (GLOBE NEWSWIRE) -- Pluristem Therapeutics, Inc. (Nasdaq:PSTI) (TASE:PLTR), a leading developer of placenta-based cell therapies, announced today a milestone in the build-out of its new clinical Good Manufacturing Process (cGMP) manufacturing facility for its Placental eXpanded (PLX) cells in MATAM Park, Haifa, Israel. Pluristem has initiated the Installation Qualification (IQ) validation process through Biopharmax Group Ltd., the company which is handling the build-out of Pluristem's facility. Following successful IQ, an Operation Qualification (OQ) will begin which marks the final stage of the build-out process prior to handing the facility over to Pluristem. The IQ/OQ validation includes systems such as the Heating, Ventilation, and Air Conditioning (HVAC), the Water for Injection (WFI), the Oil Free Air (OFA) and gas process systems.
Once constructed, the new facility will have the capacity to produce commercial grade PLX cells which will complement Pluristem's current manufacturing facility, with over 40,000 square feet. Once constructed, and assuming the PLX cells product candidates are successfully developed and approved by the regulators, the new facility would have the capacity to produce PLX cells for the treatment of over 150,000 patients annually estimated by Pluristem at $1 billion in production value.
Zami Aberman, Chairman and CEO of Pluristem commented, "We are extremely pleased with the progress of erecting one of the most technological advanced commercial grade cell manufacturing facility in the world."Pluristem had first announced in July 2011 that it is expanding its manufacturing facility as part of Pluristem's strategy to develop its "top-of-the-line" intellectual property and manufacture its cell therapy product candidates in July 2011. Pluristem's new regenerative medicine facility is designed specifically to meet both FDA and EMA regulatory requirements, as well as the standards outlined by the Israeli Ministry of Health. For more information, please visit: http://www.pluristem.com/index.php?option=com_content&view=article&id=176:-april-6&catid=4&Itemid=104 About Pluristem Therapeutics Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PLTR) is a leading developer of placenta-based cell therapies. The Company's patented PLX (PLacental eXpanded) cells are a drug delivery platform that releases a cocktail of therapeutic proteins in response to a host of local and systemic inflammatory and ischemic diseases. PLX cells are grown using the company's proprietary 3D micro-environmental technology and are an "off-the-shelf" product that requires no tissue matching prior to administration. Pluristem is focusing on the development of PLX cells administered locally to potentially treat systemic diseases and potentially obviating the need to use the intravenous route.
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