FDA approves Pluristem cell production facility

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Pluristem's Haifa plant can produce 150,000 doses of PLX cells annually.

Pluristem Therapeutics Ltd. (Nasdaq:PSTI; DAX: PJT: PLTR) today reported that the US Food and Drug Administration has approved its new facility for manufacturing stem cells for clinical and commercial use. The approval of the facility allows Pluristem to participate in advanced clinical trials in the US.

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At its new state-of-the-art GMP manufacturing facility in Haifa's MATAM park, Pluristem has implemented its proprietary, fully automated 3D cell expansion manufacturing platform that uses its patented high-throughput culturing technologies, 3D bioreactors, and downstream equipment. Pluristem's facility has the ability to efficiently produce approximately150,000 doses of PLX cells annually, with batch-to-batch consistency, which potentially translates into significant economic value

Pluristem CFO Yaky Yanay said, "As a result of this approval, 2014 will be a year of clinical trials for us. We will enter at least one and maybe two Phase II trials in the orthopdedics field, and a more preliminary trial in preeclampsia during pregnancy. The first two trials are large and so we won't have results this year but we there could be results in 2014 for the preeclampsia trial."

Pluristem chairman and CEO Zami Alberman said, "We believe we have the largest, scalable, most efficient, most consistent and controlled process for manufacturing cell therapies. Knowing that the 'Process is the Product' in cell therapy, we have established our leadership position in the industry by focusing on our 3D commercial scale cell manufacturing processes. To be a successful company in the industry, we believe it is imperative to possess and control the manufacturing processes we have developed at Pluristem. We believe this FDA approval, combined with the approval given by the Paul-Ehrlich-Institute (PEI) of Germany announced on January 23, 2014, is an indication that these regulatory bodies see our proprietary 3D manufacturing process as a valid and sustainable commercial scale solution for potential cell therapies."

Published by Globes [online], Israel business news - www.globes-online.com - on March 6, 2014