Pluristem Life System’s have completed upgrading and restructuring their manufacturing facilities to produce PLX-I, the company’s first biological product, for Phase I trials. Upon approval, the facilities could support production and shipping of more than $500,000 worth of PLX-I per day, according to the company.
“PLX-I can be used for the treatment of blood disorders and it could also be helpful in additional clinical indications like autoimmune disorders or cardiovascular diseases,” Zami Aberman, CEO, states. “It is a valuable product and we have made a strategic decision to control the production in-house. To assist us in successful Phase I clinical trials and the ultimate approval by the FDA, we have upgraded and restructured as a GMP-compliant facility.”
The manufacturing facilities include 13 units totaling 7,000-sq-ft and five cleanroom units totaling 3,000-sq-ft.