Pluri Inc. has officially introduced a new business division, PluriCDMO™, dedicated to providing cell therapy manufacturing services as a Contract Development and Manufacturing Organization (CDMO). Leveraging over 20 years of development and manufacturing experience, along with unique knowledge and technology, PluriCDMO™ aims to address key challenges in the development and manufacturing of cell-based therapies through its state-of-the-art 47 thousand square foot Good Manufacturing Practice (GMP) cell therapy production facility.
PluriCDMO™ offers a comprehensive range of services, spanning early preclinical development through late-stage clinical trials and commercialization. With a mission to deliver high-quality, essential therapies to patients, PluriCDMO™ has amassed considerable expertise in process and analytical development, process scale-up, validation, logistics, automation, and regulatory-approved comparability studies over the past two decades.
At the core of Pluri's capabilities is its proprietary, patented bioreactor system that facilitates 3D cell expansion, enabling the production of high-quality cells in mass quantities through an automated, fully controlled, and validated process. This technology supports large-scale cell growth with unique batch-to-batch consistency in a scalable, cost-effective manner under GMP conditions. Pluri's bioreactor system has been utilized to support late-stage clinical trials in key jurisdictions, including the United States Food and Drug Administration (FDA), the European Medicines Agency, Israel’s Ministry of Health, Japan’s Pharmaceuticals and Medical Devices Agency, and the Ministry of Food and Drug Safety of the Republic of Korea. Additionally, the company's PluriMatrix™ technology enables unprecedented industrial-scale production of cell-based products.
To lead the CDMO division, Pluri has appointed industry expert Andy Lewin, who brings 25 years of commercial leadership experience within the CDMO sector, having worked with global companies such as Ascend Gene and Cell Therapies Ltd., Oxford Biomedica, and AGC Biologics Inc.
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