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Pluri has launched PluriCDMO, a new contract development and manufacturing organization business that will offer cell therapy manufacturing services.
On Jan. 8, 2024, Pluri, an Israel-based biotech company, announced it launched a new business division named PluriCDMO that will offer cell therapy manufacturing services as a contract development and manufacturing organization (CDMO). The new division includes a 47,000-ft2 good manufacturing practice (GMP) cell therapy production facility.
Through this new division, Pluri will offer services relating to early preclinical development through late-stage clinical trials and commercialization. The company has expanded its experience over the past two decades to include process and analytical development, process scale-up, validation, logistics, automation, and regulatory approved comparability studies, according to a company press release.
The company operates a proprietary, patented bioreactor system that enables 3D cell expansion, allowing it to produce high-quality cells in mass quantities via an automated, fully controlled, and validated process. In addition, the company’s PluriMatrix technology enables industrial-scale production of cell-based products.
Pluri’s technology supports large-scale growth of cells and provides batch-to-batch consistency. It is also scalable, cost-effective, GMP-compliant, and has been used to support late-stage clinical trials in key jurisdictions, including FDA, the European Medicines Agency, Israeli’s Ministry of Health, Japan’s Pharmaceuticals and Medical Devices Agency, and the Ministry of Food and Drug Safety of the Republic of Korea, the company stated in its press release.
“Opening the CDMO division is a strategic move that we expect will boost revenues and cash flow utilizing our … technology and manufacturing facility,” said Yaky Yanay, Pluri’s CEO and president, in the press release. “PluriCDMO’s vision is to provide our clients with … access to valuable knowledge in cell therapy development that has been generated over the [past] two decades. PluriCDMO … can accelerate the development efforts of our partners and provide better control of the risks.”
“Pluri has an established track record of development and manufacturing in this arena and has solved many of the challenges that confront innovative companies in the cell therapy market,” said Andy Lewin, who was appointed as chief commercial officer at Pluri to lead the CDMO division, in the press release. “The [c]ompany has developed innovative production technologies, which allow it to offer large scale (and further scalable) production of cell-based products in GMP grade. Pluri’s technology, long-standing collaborations, and extensive experience enable the manufacturing of a wide range of products, including [m]esenchymal
[s]tem [c]ells (MSCs), [i]nduced [p]luripotent [s]tem Cells (iPSCs), [e]xtracellular [v]esicles (EVs) and gene-modified cells, including CAR-T [chimeric antigen receptor T] cells.”