State-of-the-art infrastructure designed to support the complete lifecycle of ATMP development, from pre-clinical research to GMP production.
Our network consists of specialized Good Manufacturing Practice cleanroom facilities, pre-GMP laboratories and a Quality Control (QC) laboratory located at Norway's major university hospitals.
Aseptic manufacturing
Automated cell processing
Long-term nitrogen storage
In-process and release testing
Together, the nodes form a coordinated national infrastructure covering pre-GMP development, GMP manufacturing, quality control, training, regulatory support and clinical translation, with projects assigned according to their technical requirements, maturity and the specialised competence and capacity available at each location. Photo: OUS
OUS-Radium provides an integrated pathway from pre-GMP development to GMP manufacturing. Services include project assessment, process and analytical development, scale-up, automation, operator training, technology transfer, GMP production of cell-based products, in-process testing, cryopreservation and local QC support. The node has experience with CAR-T, TCR-T, NK-cell products, dendritic-cell vaccines, stromal cells and GMP-grade cellular starting materials. Photo: OUS
OUS-Riks provides GMP manufacturing capacity at Rikshospitalet, particularly for hospital-based cell-therapy programmes that benefit from close integration with clinical departments. The node supports both manual and automated manufacturing and is being developed to accommodate multiple closed and automated cell-processing platforms, including projects such as CAR-T therapies for autoimmune and other indications. Photo: OUS
The Haukeland node provides regional pre-GMP and GMP capabilities for western Norway. Its services include early process development, testing and optimisation of cell-manufacturing workflows, preparation for GMP transfer, local QC support and access to GMP manufacturing. The node expands national access outside Oslo and contributes expertise in areas such as hematological malignancies and non-viral CAR-T development. Photo: Katrine Sunde
The national QC laboratory is being established as ATMP Norway’s central GMP quality control resource at Radiumhospitalet. It will provide rapid sterility testing, mycoplasma testing, ddPCR-based analyses, and other product-specific methods, together with analytical development, qualification, validation and method transfer. Its purpose is to reduce reliance on laboratories abroad and provide coordinated national QC capacity for ATMP development and manufacturing. Photo: OUS