Process development and production of advanced therapy medicinal products (ATMP)
The Karolinska ATMP Center channels research results with therapeutic potential through a process that prepares them for pharmaceutical production. Once process development is complete, production can begin. The finished drug can then be passed on to clinical trials.
For the purposes of process development and production, Karolinska Institutet and Karolinska University Hospital have facilities that are available to academic researchers, clinicians and, to a limited extent, companies:
Pre-GMP oversees the step from research finding to pharmaceutical production. Here, different methods are tested, and the process details planned by the researchers are scrutinised to establish an efficient and robust process that provides optimum product quality and ensures patient safety. Actual GMP-production then takes place in Vecura’s clean room environments.
In order to forward a medicinal product to healthcare for patient treatment or trials, different permits are required depending on the product. For all trials involving ATMPs at Karolinska University Hospital, an opinion from the hospital’s prioritization council as well as approval from the Ethical Review Board and the Swedish Medical Products Agency is required. In some cases, notification to the Swedish Work Environment Authority, including a risk assessment from the Biosafety Committee, is also necessary.
The activities of the Karolinska ATMP Center comprise research, process development, production and clinical trials.
Karolinska University Hospital offers its patients four of the six ATMP treatments that have been approved in Sweden.
Core facilities for ATMP
At Karolinska Institutet there is the Pre-GMP (Good Manufacturing Practice) core facility, which provides access to office and laboratory space, equipment and expertise for the preparation of drug production.
At Karolinska University Hospital there is the Vecura core facility, which produces ATMP for clinical trials in compliance with GMP.
The Department of Clinical Immunology and Transfusion Medicine at Karolinska University Hospital assists in the production of specific cells from patients for use in the manufacture of tailored ATMP at Vecura.
The GMP CCK production facility at the foundation Cancer Centre Karolinska (CCK) is closely affiliated with Karolinska University Hospital and Karolinska Institutet.
The Radiopharmacy facility at Karolinska University Hospital is a specialised pharmaceutical laboratory that prepares gene therapies for infusion into patients.