Orgenesis and Adva Biotechnology to Develop and Distribute Advanced Automated Culturing System for Cell Therapy Manufacturing
GERMANTOWN, Md., Feb. 06, 2018 (GLOBE NEWSWIRE) -- Orgenesis Inc., (OTCQB:ORGS), a service and research company in the field of the regenerative medicine industry with a focus on cell therapy development and manufacturing for advanced medicinal products, today announced it has entered into an agreement with Adva Biotechnology Ltd., an innovator of enhanced bioprocessing solutions, for the development of an automated culturing system for use in the provision of contract manufacturing services, as well as Orgenesis’s therapeutic development. This system has the potential to enable cost-efficient and automated manufacturing for autologous cell therapies.
Orgenesis intends to develop this technology through its joint venture with Atvio Biotech Ltd. for its in-house clinical development programs and expects to distribute the systems globally through MaSTherCell and its CDMO partners.
Vered Caplan, Chief Executive Officer of Orgenesis, stated, “Automated cell culture systems are instruments that mechanically carry out the steps involved in growing and maintaining a cell culture. The system we are co-developing Atvio Biotech and Adva Biotechnology achieves a safer, more secure and more stable large-scale production of cell cultures. The enhanced technology that we intend to implement in our systems world-wide is not only highly versatile, but also highly expandable which opens up our ability to grow various types of cells for a broad range of customer and manufacturing needs. We’re working with producers of state-of-the-art advanced cell manufacturing equipment for our development and manufacturing facilities. Now, we’re taking it a step further by collaborating directly with companies like Adva to improve our processes.”
As part of the collaboration, Orgenesis will finance part of the development and invest in the system’s market development and validation. This agreement is part of Orgenesis’s continued commitment toward nnovation in the field of autologous cell therapies by advancing their availability to patients and reducing costs by enabling closed-system automation.
The system is designed to allow single-use, closed end-to-end automated manufacturing of suspension cells such as iPSC, ES, T Cells, NK and Dendritic cells. As the field of cell therapy advances, there is a growing need for additional manufacturing capacities and technologies in a cost-effective, innovative, and automated manner. Once fully developed, the system should be able to significantly reduce cost and enhance manufacturing capacity for cell therapy companies catering to patients in need of such therapies.
About Atvio Biotech Ltd.
Atvio is a privately held, Israeli-based CDMO focused on process development, upscaling, automation and virus manufacturing for cell therapies. The company is located in Haifa utilizing the unique Israeli innovative ecosystem and a highly experienced talent pool.
Orgenesis is a vertically-integrated biopharmaceutical company with expertise and unique experience in cell therapy development and manufacturing. Through its Israeli subsidiary, Orgenesis Ltd., Orgenesis is a pioneer in the development of technology designed to successfully reprogram human liver cells into glucose-responsive, fully functional, Insulin Producing Cells (IPCs). Orgenesis believes that converting the diabetic patient's own tissue into insulin-producing cells has the potential to overcome the significant issues of donor shortage, cost and exposure to chronic immunosuppressive therapy associated with islet cell transplantation. Through its Belgian subsidiary, MaSTherCell S.A., a global Contract Development and Manufacturing Organization (CDMO), Orgenesis is able to deliver optimized process industrialization capacities to cell therapy organizations, and speed up the arrival of their therapies onto the market. From technology selection to business modeling, GMP manufacturing, process development, quality management and assay development, MaSTherCell's teams are fully committed to helping their clients fulfill their objective of providing sustainable and affordable therapies to their patients. MaSTherCell operates in a validated and flexible facility located in the strategic center of Europe within the Walloon healthcare cluster, Biowin. This integrated approach supports the Company's business philosophy of bringing to market significant life-improving medical treatments. For more information, visit www.orgenesis.com.
Notice Regarding Forward-Looking Statements
This press release contains forward-looking statements that involve substantial uncertainties and risks. These forward-looking statements are based upon our current expectations, estimates and projections and reflect our beliefs and assumptions based upon information available to us at the date of this release. We caution readers that forward-looking statements are predictions based on our current expectations about future events. These forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions that are difficult to predict. Our actual results, performance or achievements could differ materially from those expressed or implied by the forward-looking statements as a result of a number of factors, including, but not limited to, successful development of our culturing technology, the risk that the culturing technology will not work as intended or will not be accepted in the marketplace, the sufficiency of working capital to realize our business plans, the realization of our development plans even if agreements are concluded, the development of our transdifferentiation technology as therapeutic treatment for diabetes which could, if successful, be a cure for Type 1 Diabetes; our technology not functioning as expected; our ability to retain key employees; our ability to satisfy the rigorous regulatory requirements for new procedures; our competitors developing better or cheaper alternatives to our products and the risks and uncertainties discussed under the heading "RISK FACTORS" in Item 1 of our Annual Report on Form 10-K for the fiscal year ended November 30, 2016, and in our other filings with the Securities and Exchange Commission. We undertake no obligation to revise or update any forward-looking statement for any reason.
(investors) Tirth Patel
Released February 6, 2018