Pluristem gets German approval for cell therapy manufacturing process

04-Feb-2014 - Last updated on 04-Feb-2014 at 13:49 GMT

Pluristem gets German approval for cell therapy plant

German regulators have approved a 3D manufacturing process that Pluristem Therapeutics claims can produce cell therapies faster and more cheaply than standard methods.

The Paul-Ehrlich-Institute (PEI) approved the production of placenta-derived mesenchymal-like Adherent Stromal Cells (ASCs) at the plant in Haifa, Israel last month, just days before the release of positive results from trials of Pluristem’s muscle therapy, PLX-PAD.

Pluristem investor relations director, Karine Kleinhaus, told BioPharma-Reporter.com the manufacturing processes used at the site a completely different from methods used by other cell therapy firms like Dendreon and Argos Therapeutics.

“Our production method is proprietary and completely different from the current standard for expanding and modifying mesenchymal-like adherent stromal cells. We are approximately 70 times more efficient than the current industry standard for producing these types of cells and our costs are approximately 5% of the cost of the industry standard.”

Pluristem’s therapies are based on modified stromal cells derived from donated placentas, each of which is used to manufacture up to 10,000 treatments.

Kleinhaus explained that: “We take the cells from the placenta, screen and then expand them into intermediate cell stock, which is frozen and then thawed when they are to be put into our proprietary bioreactors, which modify the cells into our different cell products.

“The bioreactors are part of a tightly controlled, precise and self-enclosed system designed to produce our cells and operated in our own manufacturing facilities,” she continued, adding that “they are fully automated.”

Pluristem claims the Haifa site can manufacture 150,000 doses of its cell therapies each year, but, the firm is not yet ready to launch any of its therapies according to Kleinhaus who said: “we are still in the process of conducting trials and there are multiple milestones to achieve before commercialization.”

In related news, earlier this week Pluristem announced that the US National Institute of Allergy and Infectious Diseases (NIAID) – part of the US National Institutes of Health (NIH) – will begin a trial of its PLX-RAD product as a treatment for radiation therapy later this month.