Pluristem Therapeutics has set its sights on a new cGMP manufacturing facility for its Placental eXpanded (PLX) cells, in Haifa, Israel. Pluristem has begun the installation qualification (IQ) validation process through Biopharmax, the company which is handling the build-out of the new facility. Following successful IQ, an operation qualification will begin, which marks the final stage of the build-out process prior to handing the facility over to Pluristem.
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 sq ft. Once constructed, and assuming the PLX cells product candidates are successfully developed and approved by 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 US$1 billion in production value.
In July 2011, Pluristem announced that it is expanding its manufacturing facility to develop its intellectual property and manufacture its cell therapy product candidates. The company's new regenerative medicine facility is designed specifically to meet both FDA and EMA regulatory requirements, as well as the standards outlined by the Israeli Ministry of Health.
Pluristem's patented PLX cells are a drug-delivery platform that releases a cocktail of therapeutic proteins in response to a host of local and systemic inflammatory and ischaemic diseases. PLX cells are grown using the company's 3D micro-environmental technology and are an "off-the-shelf" product that requires no tissue matching prior to administration. Pluristem is focusing on the development of PLX cells administered locally to potentially treat systemic diseases and potentially obviating the need to use the intravenous route.