Pluristem Therapeutics Achieves Milestone Towards Completion of Its New GMP Manufacturing Facility for Commercial Production of PLX Cells
Published: Oct 23, 2012
HAIFA, Israel, Oct. 23, 2012 (GLOBE NEWSWIRE) -- Pluristem Therapeutics, Inc. (Nasdaq:PSTI) (TASE:PLTR), a leading developer of placenta-based cell therapies, announced today a milestone in the build-out of its new clinical Good Manufacturing Process (cGMP) manufacturing facility for its Placental eXpanded (PLX) cells in MATAM Park, Haifa, Israel. Pluristem has initiated the Installation Qualification (IQ) validation process through Biopharmax Group Ltd., the company which is handling the build-out of Pluristem's facility. Following successful IQ, an Operation Qualification (OQ) will begin which marks the final stage of the build-out process prior to handing the facility over to Pluristem. 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.