Pluristem Therapeutics, a developer of placenta-based cell therapies, today announced that the FDA has reviewed Pluristem's comparability studies of its PLacental eXpanded (PLX) cell products and granted approval for the company to manufacture these products in 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," stated Zami Aberman, Chairman and CEO 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 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."
At its new state-of-the-art GMP 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 approximately150,000 doses of PLX cells annually, with batch-to-batch consistency, which potentially translates into significant economic value.
About Pluristem's 3D Manufacturing
Pluristem's state-of-the-art GMP manufacturing site is located in MATAM industrial park, in Haifa, Israel and is equipped with 500 square meters of clean rooms in which PLX cells can be manufactured to support clinical trials and for commercial demand at time of regulatory approval. Pluristem develops and manufactures its products in full compliance with international quality standards, including US Food and Drug Administration (FDA), European Medicines Agencies (EMA), current Good Manufacturing Practices (cGMP) requirements and International Conference on Harmonization (ICH) quality guidelines. Pluristem believes that controlling the process is the key to success and invests significantly in developing highly efficient, cutting-edge culturing systems for its PLX cell therapy products.