06.06.14
The U.S. Food and Drug Administration (FDA) has approved Pluristem Therapeutics Ltd.'s new facility for manufacturing stem cells for clinical and commercial use. The approval allows Pluristem to participate in advanced clinical trials in the United States.
At its new state-of-the-art GMP manufacturing facility in Haifa's MATAM park, Pluristem has implemented its proprietary, fully automated 3-D cell expansion manufacturing platform that uses its patented high-throughput culturing technologies, 3-D bioreactors, and downstream equipment. Pluristem's facility can produce about 150,000 doses of PLX cells annually, with batch-to-batch consistency, which potentially translates into significant economic value, according to the company.
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."
"We believe we have the largest, scalable, most efficient, most consistent and controlled process for manufacturing cell therapies," Pluristem Chairman/CEO Zami Alberman added. "Knowing that the 'Process is the Product' in cell therapy, we have established our position in the industry by focusing on our 3-D 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, is an indication that these regulatory bodies see our 3-D manufacturing process as a valid and sustainable commercial scale solution for potential cell therapies."
At its new state-of-the-art GMP manufacturing facility in Haifa's MATAM park, Pluristem has implemented its proprietary, fully automated 3-D cell expansion manufacturing platform that uses its patented high-throughput culturing technologies, 3-D bioreactors, and downstream equipment. Pluristem's facility can produce about 150,000 doses of PLX cells annually, with batch-to-batch consistency, which potentially translates into significant economic value, according to the company.
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."
"We believe we have the largest, scalable, most efficient, most consistent and controlled process for manufacturing cell therapies," Pluristem Chairman/CEO Zami Alberman added. "Knowing that the 'Process is the Product' in cell therapy, we have established our position in the industry by focusing on our 3-D 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, is an indication that these regulatory bodies see our 3-D manufacturing process as a valid and sustainable commercial scale solution for potential cell therapies."