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March 6, 2014
06:05 EDTPSTIPluristem's commercial scale cell manufacturing process approved by FDA
Pluristem Therapeutics announced that the FDA has reviewed Pluristem's comparability studies of its PLacental eXpanded, or PLX, cell products and granted approval for the company to manufacture these products in its new commercial-scale cell manufacturing facility. 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 approximately 150,000 doses of PLX cells annually, with batch-to-batch consistency, which potentially translates into significant economic value.
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July 8, 2014
05:45 EDTPSTIPluristem Therapeutics initiates S Korean arm of Phase II IC trial
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