At Diatec Monoclonals we are also investing heavily in R&D.
We are currently engaged in two big R&D projects, partially funded by the Research Council of Norway. Both projects are in collaboration with several other partners, including companies in the biopharma and medtech space, research institutions and universities.
Project duration: 2018-2021
RCN funding: NOK 16.0 Million
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. Biotherapeutics may be further processed to radiopharmaceuticals consisting of radiolabeled conjugates used for diagnostic or treatment purposes.
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.
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 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.
Project duration: 2020-2022
RCN funding: NOK 6.9 Million
We aim to use robots for antibody production, to improve working conditions, avoid contamination, and ensure the highest possible quality of each batch.
Antibodies are large molecules that cells of our immune system produce naturally. In the healthcare industry, antibodies are used in R&D, for pharmaceuticals and/ or in vaccines.
Industrial scale production of antibodies in labs still take place inside cells, and it is important to make sure the cells are thriving. The cells grow in flasks called bioreactors; in order to thrive, they need nutrients (called medium), correct temperature, and right amounts of O2 and CO2. The cells have to be fed and “changed” regularly. “Changed” means that the nutritious medium will accumulate waste from the cells, and need to be replaced. A flask looks like a rectangular drinking bottle, and is divided into two chambers; one where antibodies are collected and can be harvested; the other where waste media is collected, and subsequently emptied and replaced. Thriving cells means more antibodies produced.
Using live cells to make antibodies for drugs is called biopharma production. This is a very complex production method, and very demanding on the operators who perform the work. To decrease the load on our operators, we want software and robots to take over parts of the process, such as feed and change, harvesting antibodies, and parts of the huge amount of measurements and logging that is required by authorities when working with diagnostics or pharmaceuticals. Antibody production takes place in clean rooms, where the hygiene requirements are extremely strict. Our biggest source of contamination are actually the people working in the rooms.
In a scenario where there is an urgent need for large amounts of antibodies, i.e. an emergency needs for vaccines or pharmaceuticals, the robots can work 24/7, seven days per week, to ensure the urgent need is met, without creating extreme working conditions for our employees.