Pluri Launches Advanced Global Cell Therapy Contract Development and Manufacturing Organization

• Pluri, an established global leader in the development and manufacturing of cell-based therapeutics, launches new revenue-generating Contract Development and Manufacturing Organization (CDMO) division.
• PluriCDMO will help innovative companies develop and manufacture life-changing therapies within the rapidly growing $5.2 billion cell and gene therapy sector.
• PluriCDMO includes Pluri’s well-established team as well as a Good Manufacturing Practice (GMP) facility and a state-of-the-art, proprietary bioreactor system enabling 3D cell expansion and supporting the manufacture of stem cells, Induced Pluripotent Stem Cells, Exosomes and Immuno therapeutics.
• PluriCDMO will offer manufacturing support from the preclinical and development stages to late stage clinical and commercial production, including fill and finish and logistics.
• Andy Lewin, an experienced CDMO executive, will head the new business division.
  

HAIFA, Israel, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Pluri Inc. (Nasdaq: PLUR) (TASE: PLUR) (“Pluri” or the “Company”), a leading biotech company that transforms cells into solutions that promote global wellbeing and sustainability, today announced it 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 47 thousand square foot 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.

Clean Room, Pluri’s Manufacturing Facility

PluriCDMO will offer services relating to early preclinical development, through late-stage 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 (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. Furthermore, the Company’s PluriMatrix technology enables unprecedented industrial scale production of cell-based products.