Pluri Launches Advanced Global Cell Therapy Contract Development and Manufacturing Organization
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Insights
The launch of PluriCDMO™ by Pluri Inc. marks a significant strategic expansion into the Contract Development and Manufacturing Organization sector for cell-based therapeutics. This move taps into the burgeoning $5.2 billion cell and gene therapy market, which is experiencing rapid growth due to advancements in biotechnology and increased demand for personalized medicine. The decision to leverage their existing expertise and facilities to provide end-to-end manufacturing solutions from preclinical to commercial stages could potentially open up new revenue streams and enhance the company's market positioning. The presence of a proprietary bioreactor system for 3D cell expansion is particularly noteworthy as it indicates a competitive advantage in terms of scalability and quality consistency, which are critical factors in the biotech manufacturing space.
Furthermore, the appointment of Andy Lewin, a seasoned executive with a track record in the CDMO industry, suggests a strong commitment to the success of this division. His experience could be instrumental in navigating regulatory landscapes and establishing robust client relationships. As biotech companies often face significant challenges in scaling up production to meet clinical and commercial demands, Pluri's full-spectrum CDMO services could attract a diverse clientele, potentially leading to a diversified revenue base. The long-term impact on Pluri's financial health will depend on the division's ability to secure contracts, maintain high-quality standards and manage operational costs effectively.
Pluri's strategic addition of a CDMO division is a forward-looking initiative that could have a profound effect on its financial performance. By capitalizing on its established GMP facility and proprietary bioreactor technology, Pluri is positioning itself to capture a larger share of the cell and gene therapy manufacturing market. The ability to offer a range of services, including the production of Mesenchymal Stem Cells, Induced Pluripotent Stem Cells and CAR-T cells, positions Pluri to address the needs of a wide array of clients in the biotech sector.
From a financial perspective, the move is likely to enhance Pluri's revenue diversification and could lead to improved cash flow. However, the success of this venture will hinge on the company's ability to efficiently scale up operations and manage the intricate logistics and regulatory requirements associated with cell therapy production. Investors will be keen on monitoring the uptake of PluriCDMO™'s services and any strategic partnerships that may arise, as these will be critical indicators of the division's contribution to Pluri's overall financial health. Additionally, the initial investment and ongoing operational expenses associated with running a CDMO will need to be balanced against the potential for increased margins and long-term shareholder value.
The regulatory landscape for cell and gene therapies is complex and varies significantly across jurisdictions. Pluri's experience in navigating this environment, as evidenced by their successful interactions with major regulatory bodies such as the FDA and EMA, is a substantial asset. The ability to conduct regulatory approved comparability studies and produce therapies under GMP conditions is critical for clients in the sector.
In terms of legal and regulatory implications, Pluri's expansion into the CDMO space will require ongoing attention to compliance with global standards. The legal expertise Pluri has garnered over 20 years will be vital in ensuring that their services meet the stringent requirements for cell therapy manufacturing. This includes intellectual property considerations, as the proprietary nature of PluriMatrix™ technology and their bioreactor system could give rise to patent licensing opportunities or necessitate defensive strategies against infringement. For clients and investors, Pluri's robust legal framework and regulatory compliance are reassuring factors that mitigate risk and enhance the credibility of their CDMO services.
- 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.
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.”
For further information on PluriCDMO™ please visit http://www.pluri-biotech.com/cdmo/
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 or follow us on LinkedIn and X (formerly known as Twitter).
Safe Harbor Statement
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws. For example, Pluri is using forward-looking statements when it discusses the potential benefits and services that may be provided by PluriCDMO™, that it expects that PluriCDMO™ will provide it with revenues and cash flow, and that PluriCDMO™ is another reflection of its strategy to use its robust 3D cell expansion assets and in-house production facilities to create long-term value for its shareholders. These forward-looking statements and their implications are based on the current expectations of the management of Pluri only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements about Pluri: changes in technology and market requirements; Pluri may encounter delays or obstacles in launching and/or successfully completing its clinical trials, if necessary; its products may not be approved by regulatory agencies, its technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; it may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with its processes; its products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; its patents may not be sufficient; its products may harm recipients or consumers; changes in legislation with an adverse impact; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluri to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluri undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluri reference is made to Pluri's reports filed from time to time with the Securities and Exchange Commission.
Media Contacts
Investors: investor.relations@pluri-biotech.com
Israel Media: Shachar Yental at shacharye@gitam.co.il
U.S. Media: Nathan Miller at nathan@miller-ink.com / Brianna Ziegler at brianna@miller-ink.com
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/ec1ceff2-66b3-4772-b37a-e8b73bdef9c1
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