Pluristem Therapeutics has moved its operations into an advanced GMP facility near Matam Park in Haifa, Israel. The facility will focus on the production of mass quantities of PLacental eXpanded (PLX) cells that can be grown using Pluristem’s 3D bioreactor technology. The new manufacturing facility will have the capability to produce different PLX product candidates with the potential capacity of over 150,000 doses annually, according to the company. Additionally, if more indications are approved by regulators for clinical trials, the new facility will enable the firm to supply PLX cells to conduct these additional trials in parallel, added a company official.
“With this new manufacturing facility, our company is capable of combining the ideal characteristics of a supply source in the placenta with a proprietary expansion technology that successfully addresses the issues of reproducibility and cost to provide high numbers of reproducible batches of the highest quality PLX cells,” said Zami Aberman, chairman and CEO of Pluristem. “Our new facility allows increasing the yield from one placenta to over ten times the yield from our previous pilot facility, and puts us in a very strong competitive position compared to traditional two-dimensional expansion technologies.”
Pluristem Therapeutics is engaged in the development of placenta-based cell therapies. PLX cells constitute a drug delivery platform that releases a cocktail of therapeutic proteins in response to a host of local and systemic inflammatory and ischemic diseases, explained Aberman. These include critical limb ischemia, intermittent claudication, adjuvant hip replacement surgery, muscle injuries, pulmonary hypertension and a number of other disorders. According to the agreement, the lease of the new facility will commence as of January 2012 for a period of approximately five years with an option to extend the lease for an additional five years.