Department for Cell Therapy

Dag JosefsenHead of department
Dag Josefsen
Head of department

The Department for Cell Therapy at Oslo University Hospital brings together clinical cell collection, cell processing, GMP manufacturing, translational research, quality management and the development of advanced therapy medicinal products (ATMPs). Located at Radiumhospitalet, the Department supports established cellular treatments and the translation of new cell and gene therapies from research into clinical use. The Department is led by Dag Josefsen, MD, PhD, who has extensive clinical, scientific and managerial experience in cell therapy, haematopoietic stem-cell transplantation, cancer immunotherapy and GMP manufacturing. As Head of Department, he has overall responsibility for its clinical services, personnel, quality systems and regulated manufacturing infrastructure.

History and development

Supporting access to commercial CAR-T therapy

The Department has a crucial role in enabling Norwegian patients to receive commercially available CAR-T therapies. It collects the patient’s white blood cells by apheresis and performs quality-assured preparation, labelling, documentation and transfer of the cellular starting material to the commercial manufacturer. The final CAR-T product is returned to the hospital for administration. Through specialised personnel, controlled procedures and close coordination with clinical teams and manufacturers, the Department provides the operational link between Norwegian patients and commercial CAR-T production.

 

Organisation

The Department is organised into five closely connected units, supported by dedicated pre-GMP and quality-control facilities.

Cell Therapy Laboratory Unit

Led by Kristina Folvik, the Unit provides the laboratory and patient-related services required for routine cell therapy at Oslo University Hospital. Its activities include apheresis and bone-marrow collection, quality control, cell processing, cryopreservation, storage, distribution and infusion of cellular products, including haematopoietic cells for autologous and allogeneic transplantation and T-cell starting material for commercial CAR-T manufacturing.

Advanced Cell Therapy Unit – ACT Centre

Led by Anna Pasetto, PhD, the ACT Centre coordinates the development and clinical translation of ATMPs. It provides a support infrastructure for regulatory strategy, process and analytical development, validation, technology transfer, agreements and preparation for GMP manufacturing, helping academic, hospital-based and commercial projects progress towards clinical trials.

Translational Research Unit

Led by Else Marit Inderberg, PhD, the Translational Research Unit connects laboratory research with clinical cell-therapy development. It provides immunomonitoring for academic and industry-sponsored trials and expertise in cellular assays, molecular biology, tumour immunology, cancer vaccines and adoptive T-cell therapies, including CAR-T and TCR-T approaches.

Quality Unit

The Quality Unit maintains and develops the quality-management system supporting the Department’s regulated activities. Its responsibilities include document control, training, deviations and CAPA, change control, risk management, qualification, validation and oversight of compliance with GMP and applicable cell and tissue requirements. Cecilie Nguyen currently serves as Quality Manager.

Islet Cell Group

Led by Hanne Scholz, PhD, senior scientist and Director of the Human Islet Isolation Facility, the Islet Cell Group has expertise in human pancreatic islet isolation and transplantation, beta-cell replacement, regenerative medicine, tissue engineering and diabetes research. The group isolates and prepares donor-derived islets for clinical transplantation and develops strategies to improve islet survival and function. In collaboration with Uppsala University Hospital and Sana Biotechnology, donor islets were engineered and GMP-manufactured at Oslo University Hospital as UP421 for a first-in-human study evaluating whether hypoimmune, insulin-producing islet cells can survive and function after intramuscular transplantation in people with type 1 diabetes without immunosuppressive treatment.

Supporting development facilities

Pre-GMP Facility

Managed by Thomas Nesset, the Pre-GMP Facility supports process and analytical development before formal GMP manufacturing. It provides a controlled environment for process optimisation, scale-up, testing of raw materials and equipment, analytical-method development, operator training and preparation of documentation for technology transfer, reducing technical and regulatory risk before clinical-grade production.

Quality Control Laboratory

Managed by Daniel Lycke Kristiansen, the new QC Laboratory is being established within ATMP Norway as a specialised national resource for ATMP testing. Its capabilities include rapid sterility testing, mycoplasma testing, digital PCR-based analyses, endotoxin testing and product-specific analytical methods, strengthening national QC capacity and supporting more efficient development and release of advanced therapies in Norway.

Together, these units and facilities provide an integrated pathway from cell collection and translational research through pre-GMP development, GMP manufacturing, quality assurance and quality control to clinical use.
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