Orgenesis Announces Collaboration Agreement With SCTbio To Expand Pocare Sites In The Czech Republic And Enhance Capabilities For The Production Of Lentivirus Vectors

Orgenesis Inc. (“Orgenesis”), a global biotech company working to unlock the full potential of cell and gene therapies (CGT) through its US-based point-of-care (POCare) services subsidiary, Morgenesis LLC (“Morgenesis”), has signed a collaboration agreement with SCTbio, a full-service contract development and manufacturing organization (CDMO) specializing in cell-based therapy and viral vectors. The goal of the collaboration is to open new point-of-care (POCare) sites within the Czech Republic and leverage SCTbio’s GMP facility for the production of lentivirus vectors to support Morgenesis’ POCare worldwide customers, including use in CAR-T cell and gene therapies (CGTs).

Orgenesis’ POCare Platform, including its Orgenesis Mobile Processing Units and Labs (OMPULs), overcomes conventional processing challenges by enabling high-quality standards and sterile, scalable onsite processing of CGTs, near local hospitals and treatment facilities. The POCare centres and OMPULs are designed to shorten the implementation time of new production, while offering a more cost-effective environment and enabling local scalability.

Lentiviral vectors are part of the family of retroviral vectors and are a fundamental component of the cell therapy manufacturing process, ensuring the delivery of the therapeutic genes into the patient’s cells. SCTbio brings expertise in retroviral vector GMP production with a deep knowledge of state-of-the-art manufacturing technologies and quality control (QC) methods.

Ludek Sojka, Chief Executive Officer at SCTbio, stated, “We are looking forward to collaborating with Orgenesis. Its POCare Platform is a unique technology supporting the development of potentially breakthrough CGTs, and we recognize the great potential for utilizing long-term experience of our team and our GMP lentiviral vector manufacturing capabilities to support Orgenesis-powered breakthroughs in Central Europe and beyond.”

Vered Caplan, CEO of Orgenesis, commented, “This partnership reflects our commitment to helping bring potential breakthrough cell therapies to market in a cost-effective, high-quality and scalable manner. We look forward to teaming with SCTbio to expand our POCare CGT production services to the region, as well as leveraging their lentiviral vector production as a key element supporting our CAR-T customers in the EU.”

About SCTbio
SCTbio is a cell-based therapy and retroviruses vector CDMO spun out from SOTIO Group in 2021, led by a tight-knit team that has been through every stage of process and product development over the last decade, bringing SOTIO’s autologous cell therapies into phase III. From its 2,000 sqm facility in Central Europe, SCTbio offers personal attention through long-term manufacturing partnerships, offering strategic development and regulatory guidance alongside full services covering GMP production, testing and logistics of advanced therapy medicinal products, including genetically modified and viral vectors.

The breadth of its experience means that SCTbio delivers the highest quality collaboration through a range of services ensuring GMP compliance for the full life cycle of drug development, that include technology transfers, process development, clinical manufacturing services, fill and finish, quality control, QA/QP release, storage and logistics.

SCTbio is member of PPF Group.

For more information , visit SCTbio.com.

About Orgenesis
Orgenesis is a global biotech company working to unlock the full potential of cell and gene therapies (CGTs) in an affordable and accessible format at the point of care. The Orgenesis POCare Platform is comprised of three enabling components: a pipeline of licensed POCare Therapeutics that are processed and produced in closed, automated POCare Technology systems across a collaborative POCare Network. Orgenesis identifies promising new therapies and leverages its POCare Platform to provide a rapid, globally harmonized pathway for these therapies to reach and treat large numbers of patients at lowered costs through efficient, scalable, and decentralized production. The POCare Network brings together patients, doctors, industry partners, research institutes and hospitals worldwide to achieve harmonized, regulated clinical development and production of the therapies. For more information, visit www.orgenesis.com.