Pluristem Begins Up Scaling Its PLX Cell Bioreactors
Scale Up of Bioreactors to Allow Production of About 30 Billion Cells With Each Reactor Run
HAIFA, Israel, Mar 12, 2012 (GlobeNewswire via COMTEX) -- Pluristem Therapeutics, Inc. (Nasdaq:PSTI) (TASE:PLTR) today announced that it has initiated the process of scaling up the Company's manufacturing bioreactors from their current size of 5 liter (L) to 15L. The up scaling process is being coordinated to go on-line as part of Pluristem's current plant expansion. With the completion of the scaling up process, Pluristem will be positioned to become the leading manufacturer of cells for a variety of product candidates.
The 15L bioreactors will accommodate the commercial production of Pluristem's PLacental eXpanded (PLX) cells that will be used in both the Company's upcoming pivotal Critical Limb Ischemia (CLI) clinical trial and the subsequent commercial sales of the cell product once approved.
Utilizing Pluristem's proprietary 3D manufacturing technology, a 15L bioreactor will yield approximately 30 billion PLX cells per reactor run, enough PLX cells for 100 doses at a dose of 300 million cells, the dose that will be used in the CLI clinical trial.
"The large-scale manufacturing of our PLX cells is vital to the success of our clinical trials and subsequently important for the potential commercialization of our PLX products," said Zami Aberman, Chairman and CEO of Pluristem. "Today, we initiated an additional important step in our industrialization process, where we utilize our proprietary 3D production technology, in order to manufacture trillions of cells in a stable, fully controlled and cost effective manufacturing operation. I believe that these competitive advantages strongly position us to provide viable therapies to millions of patients around the world once our products are fully developed and approved." |
