The new 28K GMP facility will be capable of a expanding production capacity
PSTI has entered into an agreement with MTM – Scientific Industries Center Haifa Ltd., for the leasing and construction of a new state-of-the-art GMP manufacturing facility. The new facility will be located in existing facilities in MATAM Park, Haifa, Israel and will support the manufacturing of PLX (Placental eXpanded) cell product candidates for the treatment of critical limb ischemia (NYSE:CLI), intermittent claudication (IC), adjuvant hip replacement surgery, muscle injuries, pulmonary hypertension (NYSE:PH) and other diseases.
The Bottom Line: The facility must be cGMP/GTP compliant for clinical cell manufacturing and designed specifically to meet both EMA and FDA regulatory requirements, as well as the standards outlined by the Israeli Ministry of Health. Once constructed … the new facility would have the capacity to produce PLX cells for the treatment of over 150,000 patients annually.