Pluristem (PSTI) Initiates IQ Process at cGMP Facility
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Pluristem Therapeutics, Inc. (Nasdaq: PSTI) 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.
Once constructed, the new facility will have the capacity to produce commercial grade PLX cells which will complement Pluristem's current manufacturing facility, with over 40,000 square feet. Once constructed, and assuming the PLX cells product candidates are successfully developed and approved by the regulators, the new facility would have the capacity to produce PLX cells for the treatment of over 150,000 patients annually estimated by Pluristem at $1 billion in production value.
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.
Once constructed, the new facility will have the capacity to produce commercial grade PLX cells which will complement Pluristem's current manufacturing facility, with over 40,000 square feet. Once constructed, and assuming the PLX cells product candidates are successfully developed and approved by the regulators, the new facility would have the capacity to produce PLX cells for the treatment of over 150,000 patients annually estimated by Pluristem at $1 billion in production value.
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