Israel-based Pluristem Therapeutics, Inc. recently announced the initiation of the final validation steps for its new state-of-the-art manufacturing facility. Subsequent to this validation, Pluristem will take possession of the facility.
The validation process include the validation of several installation systems including heating, ventilation and air conditioning (HVAC), water, oil free air and sterile room systems.
According to Pluristem, this facility is the world’s first commercial cell therapy manufacturing facility.
Pluristem develops placenta based cell therapies. The cells from placenta are derived using the company’s proprietary PluriX therapy and are known as PLacental eXpanded (PLX) cells.
The new facility will have the capacity to produce PLX cells for the treatment of over 150,000 patients per annum representing $1 billion in production value if and when the PLX cells product are successfully developed and approved by the regulators.
In addition, the new facility will enable Pluristem to supply PLX cells to conduct clinical trials which are approved by regulators for additional indications.
We note that Pluristem has collaboration deals with companies like United Therapeutics Corporation
(UTHR - Analyst Report
Management believes that PLX cells can be effective in supporting bone marrow transplantation and in treating bone marrow suppression from radiation and chemotherapy.
Earlier, Pluristem had announced that the US Food and Drug Administration (FDA) updated the former related to its application to designate PLX cells orphan drug status in the treatment of aplastic anemia.
According to FDA, Pluristem is required to provide additional information and data for further analysis before the FDA can determine if the PLX cells can qualify for orphan drug designation for aplastic anemia, which affects less than 200,000 people in the US.
Celgene Cellular Therapeutics, a wholly owned subsidiary of Celgene Corporation
(CELG - Analyst Report
is also doing research on stem cells derived from the human placenta as well as from the umbilical cord for the treatment of different diseases.
We currently have a Neutral recommendation on Pluristem, which carries a Zacks #3 Rank (Hold).