The biotech company Pluri has launched a new business division offering cell therapy manufacturing services as a Contract Development and Manufacturing Organization (CDMO): PluriCDMO.

PluriCDMO will offer its unique knowledge and technology and over 20 years of development and manufacturing experience. Its state-of-the-art Good Manufacturing Practice (GMP) cell therapy production facility is expected to help customers and partners address key challenges in the development and manufacturing of cell-based therapies.

PluriCDMO will offer services relating to early preclinical development, through latestage clinical trials and commercialization, with a mission to deliver high-quality, essential therapies to patients. Over the past two decades, Pluri has cultivated a wealth of experience in process and analytical development, process scale-up, validation, logistics, automation, and regulatory approved comparability studies.

The company’s proprietary, patented bioreactor system enables 3D cell expansion, producing high-quality cells in mass quantities through an automated, fully controlled and validated process. Pluri’s unique technology supports the large-scale growth of cells, with unique batch-to-batch consistency in a scalable, cost-effective manner, under GMP conditions, and has been used to support late-stage clinical trials in key jurisdictions, including the United States Food and Drug Administration; 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.

Furthermore, the company’s PluriMatrix technology enables unprecedented industrial scale production of cell-based products. Pluri has appointed industry expert, Andy Lewin, to lead the business of its CDMO division. Lewin brings 25 years of commercial leadership experience within the CDMO sector in global companies including Ascend Gene and Cell Therapies, Oxford Biomedica, and AGC Biologics.

Cell-based products “Pluri has an established track record of development and manufacturing in this arena and has solved many of the challenges th0at confront innovative companies in the cell therapy market,” said Lewin. “The company 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 Mesenchymal Stem Cells, Induced Pluripotent Stem Cells, Extracellular Vesicles and gene modified cells, including CAR-T cells. Pluri offers a level of support to its partners that is second to none. I am excited to lead this new division, addressing the prevalent challenges and need in this sector, helping to accelerate the development and commercialization of high-quality cell and gene therapy products.”

For more information on PluriCDMO, visit: http://www.pluri-biotech.com/cdmo