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news.The US Food and Drug Administration (FDA) has reviewed Pluristem Therapeutics' comparability studies of its PLacental eXpanded (PLX) cell products and granted approval to manufacture these products in its new commercial-scale cell manufacturing facility.
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At the new GMP manufacturing facility, the company has implemented its proprietary, fully automated 3D cell expansion manufacturing platform that uses its patented high-throughput culturing technologies, 3D bioreactors, and downstream equipment.
The company’s facility has the ability to efficiently produce about 150,000 doses of PLX cells per year, with batch-to-batch consistency, which potentially translates into significant economic value.
Pluristem chairman and CEO Zami Aberman said the company believes that it has 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," Aberman said.
"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."
The company’s GMP manufacturing site is located in MATAM industrial park, in Haifa, Israel and is equipped with 500m² of rooms in which PLX cells can be manufactured to support clinical trials and for commercial demand at time of regulatory approval.