Pluristem Therapeutics has announced that it has completed the approval process and received final clearance from a fifth regulatory agency for its 3D cell therapy manufacturing processes in use at its new facility in Haifa. The latest approval comes from Israel's Ministry of Health and follows similar clearances from the U.S. Food and Drug Administration, the European Union 's Qualified Person, Germany 's Paul Ehrlich Institute, and the South Korean Ministry of Food and Drug Safety.
"This latest regulatory clearance further validates our proprietary cell manufacturing processes, which we believe are state-of-the-art and unmatched in the cell therapy arena. Our Haifa facility has the capacity to produce approximately 150,000 doses of PLX cells annually, with batch-to-batch consistency, which potentially translates into significant economic value," stated Pluristem CEO Zami Aberman. "This latest approval also exemplifies our strategy of working with multiple regulatory bodies in order to establish Pluristem as a leading developer of cell therapies and to set the standards for this area of manufacturing," added Aberman.
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 in sufficient quantities to support late-phase clinical trials and commercial demand at time of regulatory approval. Pluristem manufactures its products in full compliance with the U.S. Food and Drug Administration (FDA) and European Medicines Agencies (EMA) current Good Manufacturing Practices (cGMP). Pluristem believes that control of the production process is critical for the successful manufacture of cell therapies and invests significantly in developing highly efficient, cutting-edge culturing systems for its range of PLX cell products.