Pluristem Therapeutics’ new manufacturing facility has been approved by European auditors and has received the Qualified Person Declaration. The approval allows the company to use cell therapies manufactured at its facility in Haifa, Israel, in Phase I-III trials conducted in the EU.
The audit for manufacturing and cell expansion operations covered design, construction, and validation of the new facility, equipment, utilities, and quality management systems in accordance with GMP legislation, directives and guidelines.
The facility houses the company’s fully automated 3D cell expansion manufacturing platform that uses high-throughput culturing technologies, 3D bioreactors, and downstream equipment, with the ability to produce approximately 150,000 doses of PLX cells annually.
"This Qualified Person declaration enables us to expand our clinical site locations into any European Union member nation through each phase of our trials," stated Zami Aberman, chairman and chief executive officer of Pluristem. "We believe Pluristem's advanced, commercial scale cell manufacturing facility is one of our Company's key strategic assets and gives us significant competitive advantage in the industry as we move our clinical development pipeline forward."