Pluristem Therapeutics achieved a milestone in the build-out of its new clinical cGMP manufacturing facility for its Placental eXpanded (PLX) cells in Matam Park, Haifa, Israel. The company initiated the Installation Qualification (IQ) validation process through Biopharmax Group, which is handling the build-out of the facility. Following successful IQ, an Operation Qualification (OQ) will begin, which marks the final stage of the process. The IQ/OQ validation includes systems such as the Heating, Ventilation, and Air Conditioning (HVAC), the Water for Injection (WFI), the Oil Free Air (OFA) and gas process systems.

Once completed, the 40,000-sq.-ft. facility will have the capacity to produce commercial grade PLX cells. If the PLX cells product candidates are successfully developed and approved, the new facility would have the capacity to produce PLX cells for the treatment of more than 150,000 patients annually. The new regenerative medicine facility is designed specifically to meet FDA and EMA regulatory requirements, as well as the Israeli Ministry of Health standards.  

Zami Aberman, chairman and chief executive officer of Pluristem said, “We are extremely pleased with the progress of erecting one of the most technological advanced commercial grade cell manufacturing facility in the world.”