Pluristem Therapeutics, Inc. has received approval from the FDA for the comparability studies of its PLacental eXpanded (PLX) cell products and was granted approval for the manufacture these products at its new commercial-scale cell manufacturing facility.

“We believe we have the largest, scalable, most efficient, most consistent and controlled process for manufacturing cell therapies,” said Zami Aberman, chairman and chief executive officer of Pluristem. “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, is an indication that these regulatory bodies see our 3D manufacturing process as a valid and sustainable commercial scale solution for potential cell therapies.”

At its new GMP manufacturing facility, the company has implemented its fully automated 3D cell expansion manufacturing platform that uses high-throughput culturing technologies, 3D bioreactors, and downstream equipment. According to the company, the facility has the ability to produce approximately 150,000 doses of PLX cells annually, with batch-to-batch consistency.