We are preparing for the launch of the MabionCD20 medicinal product on the European and US markets and we are implementing contract manufacturing services (CDMO).
Projects currently in progress
A MabThera/Rituxan (rituximab) biosimilar drug, whose efficacy and safety were clinically confirmed. It is the first such advanced drug developed in Poland. We are currently at the final stage of works aimed at marketing the drug in Europe and the United States.
This is our most advanced in-house project.
We are implementing the project as part of contract manufacturing services for Novavax, Inc. (USA). To date, as part of the collaboration, we have successfully completed the transfer of technology for the production of vaccine antigen (i.e., recombinant protein that is the active ingredient of the vaccine), and analytics of this product to our manufacturing facility. We are now commencing regular pharmaceutical production of the antigen under Good Manufacturing Practice (GMP) standards. Our product will go into Novavax’s global manufacturing network and will be our contribution to the fight against the COVID-19 pandemic. This is a very good example of how we are experts in therapeutic proteins. Regardless of the expression system, the structure of the protein, or its application (treatment or prevention of disease), we can deliver a product that meets the highest standards.
Therapeutic biosimilar monoclonal antibodies
We are in the initial stages of selection for the development of further biosimilar drugs. We will keep you updated on the details.
We believe that there is a huge demand for advanced therapies in indications that, due to smaller patient populations, do not receive the attention of major players in the pharmaceutical market. In our view, this is a very important, under-addressed segment of the pharmaceutical market, while also being very attractive to companies that are technologically and organizationally advanced and dynamic. We feel that this is one of the spaces that we can fill by supporting unaddressed medical needs, which is important for regulators and, above all, patients.
We are currently working to initiate a collaboration to research, develop and commercialize the MabionCD20 medicinal product based on rituximab for specific clinical indications in the area of autoimmune diseases.