Leading placenta-based cell
therapy developer Pluristem Therapeutics announced the U.S. FDA has reviewed
the company’s comparability studies of PLacental eXpanded (PLX) cell products
and has granted approval for Pluristem to manufacture these products in its
new, commercial-scale cell manufacturing facility.
Pluristem has established
its industry leadership position by focusing on its 3-D commercial-scale cell
manufacturing process, and the company believes it has the largest, most
efficient, most consistent and most controlled process for manufacturing cell
therapies.
“To be a successful company
in the industry, we believe it is imperative to possess and control the
manufacturing processes we have developed at Pluristem,” said Pluristem
Chairman and CEO Zami Aberman. “We believe this FDA approval, combined with the
approval given by the Paul-Ehrlich-Institute (PEI) of Germany announced on Jan.
23, 2014, is an indication that these regulatory bodies see our proprietary 3-D
manufacturing process as a valid and sustainable commercial-scale solution for
potential cell therapies.”
At Pluristem’s new,
state-of-the-art GMP manufacturing facility, located in MATAM industrial park
in Haifa, Israel, the company has implemented its proprietary and fully
automated 3-D cell expansion manufacturing platform, which uses patented high
throughput culturing technologies, 3-D bioreactors, and downstream equipment.
This facility is capable of efficiently producing around 150,000 doses of PLX
cells each year with batch-to-batch consistency, which will potentially
translate into great economic value.
For more information about
Pluristem, visit the company’s website at visit www.pluristem.com
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