Pluristem Therapeutics Says FDA Oks Commercial Scale Cell Manufacturing Process

(RTTNews) - Pluristem Therapeutics Inc. (PSTI) announced that the United States Food and Drug Administration or FDA has reviewed the company'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.

"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.... 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," stated Zami Aberman, Chairman and CEO of Pluristem.