Development of new production technologies for biopharmaceuticals

Diatec Monoclonals is currently running a grant supported research project which involves 10 partners with the aim of developing and improving production technologies for new biologics manufacturing. The project has a total budget of 36 million NOK and is supported by the BIA-program at the Norwegian Research Council. BIA funds industry-oriented research and is a broad-based programme supporting high-quality R&D projects with good business and socio-economic potential. The project will be running until the end of 2021.

Abstract: Development of new production technologies for biopharmaceuticals

Biotherapeutics make up a class of drugs including proteins and peptides, which are generally produced in living organisms and used for treatment of a wide variety of diseases including cancer, diabetes, and rheumatoid arthritis. These products also provide genuinely new strategies against infectious agents and orphan diseases alike. Despite the wide and highly increasing use of biotherapeutics and their commercial and economic value there is currently no established commercial manufacturing of biotherapeutics in Norway. Biotherapeutics may be further processed to radiopharmaceuticals consisting of radiolabeled conjugates used for diagnostic or treatment purposes. The overall goal for this R&D-project is to establish new production technologies enabling competitive process development and manufacturing for protein based pharmaceuticals, including radiopharmaceuticals. As a necessary approach the aim of this R&D-project will be to develop improved bioreactor upstream processes, improved analytical methods for better product characterization and new production process automatization including use of robotics during radioisotope handling. Furthermore, the project will include set-up of new test facilities based on method transfer and development for both new GMP upstream and downstream (purification) processes. The project will be a collaboration between different scientific and technical partners with expertise within cell cultivation, bioanalytical methods, biopharmaceutics process manufacturing (upstream and downstream), process sensor technologies, manufacturing of radiopharmaceuticals, automatization and robotics. The current project aims to be an initiator for the Norwegian pharmaceutical industry through stimulating and enabling the building of new competitive biopharmaceutical business on a large scale within a highly promising area.