Thermo Fisher, Pluristem partner to scale up regenerative cell therapy manufacturing

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The partnership aims to combine Thermo Fisher’s experience in bioproduction with Pluristem’s work in cell therapy manufacturing, including a recent trial that evaluated placental stromal cell doses derived from multiple donor organs. (Pixabay)

Placenta-based cell therapy company Pluristem Therapeutics has launched a collaboration with Thermo Fisher Scientific to help scale up the manufacturing of regenerative medicines, with the goal of building a large-scale industry capable of producing millions of doses.

The partnership aims to combine Thermo Fisher’s experience in bioproduction and supply chains with Pluristem’s work in cell therapy manufacturing, clinical development and quality control, the companies said in a statement.

“From early on, our strategy was to build an in-house manufacturing facility,” said Pluristem’s president and co-CEO, Yaky Yanay. “Having achieved that, we are now in a unique position within the industry, and have a broad understanding of its needs.”

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Pluristem described how over 850 companies worldwide are developing regenerative medicines and advanced therapies, with over 900 clinical trials underway, plus several international product approvals in the past year.

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For the regenerative medicine sector to serve more patients, the company called for changes in the supply chain of equipment, consumables, reagents and storage systems.

“Thermo Fisher, known for its biopharmaceutical infrastructure, materials supply, logistics, and manufacturing expertise, is a perfect partner for Pluristem,” Yanay said in the statement. “This initiative has the potential to advance the industry significantly, allowing regenerative medicine to realize its potential, treating millions of patients globally while reducing healthcare spending.”

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Haifa, Israel-based Pluristem, which develops treatments based on placenta-derived adherent stromal cells, unveiled topline results last month from a phase 2 study of its PLX-PAD cell therapy. The trial of 172 patients with intermittent claudication, or painful cramps associated with peripheral artery disease, represented the company’s largest data set to date. After one year (PDF), patients treated with two intramuscular administrations of 300 million PLX-PAD cells showed improvements of 51% in maximal walking distance compared to placebo, with a p-value of 0.015. As a secondary endpoint, the study also evaluated Pluristem’s proprietary manufacturing approach of developing doses originating from different placentas, which demonstrated a smaller improvement in walking distance, with 42%, and with a weaker p-value of 0.043.

“The unique PLX platform and manufacturing processes we developed enable us to confirm donor-to-donor and batch-to-batch comparability and achieve optimal clinical benefits,” Pluristem Chairman and Co-CEO Zami Aberman said at the time. “These results suggest that PLX-PAD cells may be efficacious in the treatment of PAD and could significantly reduce the need for invasive procedures in these patients.”