-
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 – Pluri Inc. (Nasdaq: PLUR) (TASE: PLUR), 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.
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)
- European Medicines Agency; Israeli’s Ministry of Health
- Japan’s Pharmaceuticals and Medical Devices Agency
- 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. Mr. 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 Andy 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. 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.”
Pluri’s CEO and President Yaky Yanay said, “Opening the CDMO division is a strategic move that we expect will boost revenues and cash flow utilizing our well-established technology and manufacturing facility. PluriCDMO™’s vision is to provide our clients with the best-in-class facility, but more importantly, the access to valuable knowledge in cell therapy development that has been generated over the last two decades. PluriCDMO™, as a high-end boutique CDMO, can accelerate the development efforts of our partners and provide better control of the risks. We believe that our proposition is strong and unique, working with PluriCDMO™ can be the launching pad that so many companies can benefit from. Our new CDMO division is another reflection of Pluri’s strategy to use our robust 3D cell expansion assets and in-house production facilities to create long-term value for our shareholders.”
About Pluri Inc.
Pluri is pushing the boundaries of science and engineering to create cell-based products for commercial use and is pioneering a biotech revolution that promotes global wellbeing and sustainability. The Company’s technology platform, a patented and validated state-of-the-art 3D cell expansion system, advances novel cell-based solutions for a range of challenges— from medicine and climate change to food scarcity, animal cruelty and beyond. Pluri’s method is uniquely accurate, scalable, cost-effective and consistent from batch to batch. Pluri currently operates in the field of regenerative medicine, food-tech and biologics and offers CDMO services. The company establishes partnerships that leverage its 3D cell-based technology for various industries that require effective, mass cell production. To learn more, visit us at www.pluri-biotech.com.
To learn the identities of all competitors within this rapidly expanding market, view the “Global Database of Cell and Gene Therapy CDMOs, 2024“.
