Pluri Inc., a biotech company, launched a new business division offering cell therapy manufacturing services as a contract development and manufacturing organization (CDMO), PluriCDMO.

PluriCDMO will offer development and manufacturing services from its state-of-the-art, 47,000 sq.-ft. GMP cell therapy production facility to help customers address key challenges in the development and manufacturing of cell-based therapies.

PluriCDMO will offer services for early preclinical development through late-stage clinical trials and commercialization. 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 bioreactor system enables 3D cell expansion, producing high-quality cells in mass quantities through an automated, fully controlled, and validated process. Pluri’s technology supports the large-scale growth of cells, with unique batch-to-batch consistency in a scalable, cost-effective manner, under GMP conditions. The company’s PluriMatrix technology enables industrial scale production of cell-based products.

Pluri appointed Andy Lewin to lead the CDMO division. Lewin brings 25 years of commercial leadership experience within the CDMO sector in global companies including Ascend Gene and Cell Therapies Ltd., Oxford Biomedica, and AGC Biologics Inc.

“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 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 (MSCs), Induced Pluripotent Stem Cells (iPSCs), Extracellular Vesicles (EVs) and gene modified cells, including CAR-T cells.