Biological medicines are among the most significant achievements in medicine, since they are more specific, have fewer side effects and are able to cure previously incurable diseases. Slovenia has also had some success in this area: the first biomedicine approved in the USA was developed by Lek and the National Institute of Chemistry.
The main challenge in the manufacturing of biomedicines is their complexity; they are namely proteins produced by genetically modified cells in controlled environments – bioreactors. The smallest of changes in the cells, the manufacturing environment and the conditions can significantly affect the final quality and efficiency of the medicinal product. Even though biopharmaceutics is one of the most promising branches with the estimated market value of USD 190 billion in 2019, it is currently facing the lack of manufacturing capacities and the difficulties related to the transfer of technology from laboratories to the production level.
Metronik cooperates in the activities of the BioPharm.SI programme, which connects the top-level Slovenian companies and research organisations, as a consortium partner. The main goal of the programme is development of stable, high-quality and reproducible biomedicine manufacturing processes. The programme is based on the excellent possibility of launching the developed products on the global market, also via the Novartis network.
The foundation of the research programme will be the development of stable cell line, regular monitoring of the process parameters with newly developed methods and devices, IT and analytical support, modelling and simulation of processes that will be able to predict and regularly direct the manufacturing flow. Furthermore, the programme will comprise the development of a continuous process in which large amounts of medicines can be produced with small reactors on an on-going basis.
With its innovative solutions, BioPharm.Si will put Slovenia on the biopharmaceutical global map; it will stimulate the transfer of the research results to the market and offer competitive advantage to companies. Its principal outcome will be the patents and innovations, new products, services and technologies, more private investments in research and development, new companies, increased added value and jobs with high added value.
