Pluristem to open new PLX facility
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.