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SCTbio and Cyto-care collaborate to improve cell therapy cryopreservation and logistics capabilities in Europe
Prague, Czech Republic and Vienna, Austria, June 15, 2023 – SCTbio, a full-service contract development and manufacturing organization (CDMO) specializing in cell-based therapy and viral vectors, and Cyto-care.eu GmbH, a company that specializes in providing advanced solutions for cell therapy and regenerative medicine, have signed a collaboration agreement to improve the quality of cryopreservation for cell therapy development in Europe. The goal of the collaboration is to address the critical need for efficient collection, cryopreservation, quality control and logistics capabilities of leukapheresis materials to support various aspects of the cell therapy workflow.
Cell collection through leukapheresis procedure is a key enabling step for manufacturing advanced cell therapies products (ATMPs), cutting-edge medicines made from human cells or tissue that are today life-saving therapies. The quantity and quality of collected immune cells, like T cells and natural killer cells used for cell therapies, directly impact the potency, safety and efficacy of the final therapeutic product. As such, efficient cryopreservation and logistics of these leukapheresis materials are critical to ensure the preservation of cell viability and functionality during transportation and storage.
SCTbio and Cyto-care.eu are dedicated to pushing the boundaries of delivering the highest quality and integrity of blood materials drawn from leukapheresis to healthcare professionals in Europe, to advance medical research and support development of personalized therapies, ultimately leading to improved patient outcomes. Together, Cyto-care.eu and SCTbio will provide a reliable and accessible platform for collecting, characterizing, preserving, and transporting leukapheresis samples.
Luděk Sojka, CEO of SCTbio, stated, “We are thrilled to combine both forces and expertise with Cyto-care.eu, a European leader in producing quality blood-based products from leukapheresis, through this strategic partnership. As the cell and gene therapy field continues to advance, the demand for leukapheresis materials is expected to increase. Clinical trials and commercial production of these therapies require a consistent and reliable supply of high-quality blood-derived products to meet patient needs.”
“Through rigorous analysis and in-depth discussions with the experts of the field, the Needle-to-Freezing time has been identified as a crucial factor for success for the development and manufacturing of ATMPs,” said Klaus Fischer, Cyto-care.eu’s Managing Director. “Through this collaboration with SCTbio, we can ensure that our leukapheresis products from patients and from donors continue to meet the high-quality standards of our customers’ requirements.”
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 & finish, quality control, QA/QP release, storage and logistics.
Cyto-care.eu performs leukapheresis, providing both cells and knowledge around cells. Our products include R&D-grade as well as clinical (patient) leukapheresis. With more than 1,100 recallable donors on file, we can supply any project with high-quality leukopaks. With over 20 years of experience in the collection and processing of human cells and rare materials, we have accumulated profound knowledge and expertise in the field of cell & gene therapy and related supply chains. GMP conditions for healthy donors and for patients are implemented on request, allowing the quick transformation of your project from R&D to clinical study protocols and to commercialization.
Thursday, 15 June 2023