IFE Radiopharmaceutical Production consists of the departments of Aseptic and Sterile Production, Visual Control and Packing, Chemical Quality Control, Microbiological Quality Control, Warehousing and Logistics as well as the Department for Process and Validation.
Being a contract manufacturer for the commercial production of radiopharmaceuticals is our most comprehensive activity. We also produce radiopharmaceuticals for clinical testing and have expertise in both sterile and aseptic production. For several years, IFE has collaborated with Bayer (formerly Algeta) on product development, expansion and building of premises and equipment for contract production of Xofigo, a drug based on the radioisotope Ra-223, which is used for the treatment of cancer patients with spread to the skeleton. The product was approved in the United States in May 2013, and in Europe in November 2013. IFE has since May 2013 routinely produced Xofigo.
IFA has, in cooperation with partners, built up and installed a lot of new equipment, both automated lines and more manual equipment. An example is an automated packing line which includes automated visual inspection using robots, automated labeling of glass, and labeling of lead pots that protect the radioactive drug/glass. The production of radiopharmaceuticals is carried out in accordance with the pharmaceutical authorities’ strict quality requirements and GMP regulations (Good Manufaturing Practice). This implies, among other things, that employees are qualified for all the tasks that are performed, equipment is thoroughly tested and checked before use, all work and all control routines are carried out according to written procedures and everything is carefully documented. All equipment used is qualified according to established guidelines. The Process and Validation department is responsible for the maintenance and calibration of production equipment, re-qualification of processes, production equipment and technical systems. IFE is continuously working on routines and quality assurance to comply with pharmaceutical authorities as well as radiation protection authorities. Our employees must be exposed to the lowest possible risk while at the same time delivering a safe product to health personnel and to the individual patient.
IFE Radiopharmaceutical Production is working on a number of development projects. It is of utmost concern for IFE to safeguard this activity and be able to offer small start-up companies production opportunities, where the requirements for the production of pharmaceuticals are complied with, while at the same time safeguarding radiation protection concerns. IFE Pharmaceutical Production also offers quality control services to our customers, including sterile testing of radiopharmaceuticals in both the commercial and clinical phases, as well as the development of radiochemical / chromatographic methods. The sector is also responsible for production planning, procurement, goods reception and warehousing.