Handling and manufacturing of cell therapy products within the hospital
Cell therapy is a form of treatment that requires involvement of several specialized units within Karolinska University Hospital, such as the Vecura tissue units and the Center for Apheresis and Stem Cell Handling (CASH).
Vecura is a development facility that produces investigational medicinal products for cell and gene therapy. Many different types of cells are processed, based on need and demand. Go directly to the Vecura web site.
The Center for Apheresis and Stem Cell Handling (CASH)
CASH provides routine services, conducts clinical research and carries out therapeutic apheresis for clinical use. CASH handles stem cells, blood cells and vascular grafts.
Permits and Inspection
The tissue facilities have specific capabilities for handling cells and tissues for both health care and clinical research. Tissues and cells for therapeutic use in humans are handled in tissue facilities that require permits and that must comply with the Health and Social Care Inspectorate (IVO), formerly the National Board of Health and Welfare, and the Swedish Medicinal Products Agency directive pursuant to the Act (2008:286) on standards of quality and safety in use of human tissues and cells.
Health and Social Care Inspectorate (IVO)
IVO is the licensing and regulatory authority when tissues and cells are to be used in humans for purposes other than pharmaceutical manufacturing.
Medicinal Products Agency
The Medicinal Products Agency issues licenses for running tissue facilities involved with handling human tissues and cells to be used for the manufacture of medicinal products. When cells are significantly modified, they are classified as medicinal products. In such cases manufacturing authorization from the MPA is required, the handling of the cells needs to be in accordance with Good Manufacturing Practices (GMP) and the finished medicinal product must be released by a qualified person (QP).
Phone: +46 (0)70-756 22 60
E-mail: Fredrik Öhrn