‘Smart Growth’ Operational Programme
Co-funding was provided for the project entitled: ‘Development of an innovative form of medicine containing a monoclonal antibody for use in the treatment of non-specific enteritis’. The value of the granted aid was PLN 57,847,160.39. The total cost of project implementation is PLN 107,809,664.70.
The purpose of the project is to develop an innovative form (formulation) of a medicinal product that contains a monoclonal antibody biosimilar to vedolizumab (trade name Entyvio®) – a medicinal product obtained through DNA recombination in cells where a gene that codes its amino acid sequence has been introduced. It is used for the treatment of adult patients with ulcerative colitis (which causes inflammation and ulcers of the intestinal lining) or Crohn’s disease (which causes inflammation of the gastrointestinal tract). In addition, the project aims to develop a laboratory-scale culture and purification process that is much more efficient than the original vedolizumab manufacturing process and then resize it to a commercial scale.
Co-funding was provided for the project entitled: ‘Development of a monoclonal antibody with a more favourable safety profile for use in the treatment of psoriasis’.The value of the granted aid was PLN 64,045,249.31. The total cost of project implementation is PLN 124,185,682.80.
The purpose of the project is to develop a monoclonal antibody biosimilar to ustekinumab, which is characterised by an improved safety profile. Ustekinumab, marketed as Stelara®, is a medicinal product used for the treatment of psoriasis, psoriatic arthritis and Crohn’s disease. An improved safety profile for the biosimilar ustekinumab will be obtained by using a different cell line in the production process other than that of the reference product. Using genetic engineering methods, the cell line will receive specific enzymes that provide the protein obtained with a typically human glycosylation profile, as opposed to the mouse glycosylation profile of the reference product.
Co-funding was provided for the project entitled: ‘Development of a globally innovative technology for manufacturing therapeutic antibodies based on bacterial expression systems, integrating stainless steel and single-use technologies’.The value of the granted aid was PLN 6,785,029.97. The total cost of project implementation is PLN 16,962,574.96.
The purpose of the project is to develop a globally innovative technology for the production of a fragment of a monoclonal antibody obtained in E.coli cells using DNA recombination technology. The project involves the implementation of work based on an innovative technology for the production of an mAbs fragment based on bacterial expression systems. The implementation of the results will make it possible to launch a highly effective in-house production of the protein fragment in question. The scope of development work includes research aimed at increasing the scale of the new process to a fully GMP-compliant manufacturing scale, while at the same time, developing analytical and biological methods. The process innovation planned to be implemented on a global scale involves the integration of the conventional stainless-steel technology used in both downstream and upstream processes with innovative single-use solutions, which until now, have never been used for manufacturing reference substances. This innovation will increase the flexibility and cost effectiveness of manufacturing operations compared to the reference product, while maintaining a high level of product safety, which is an innovation on a global scale. The project is a response to the growing number of patients with macular damage (AMD, DME, RVO) caused, among others, by social and demographic developments associated with the ageing population. The implementation of the project aims to develop the world’s first industrial-scale technology for the antibody fragment under study in the project.
Co-funding was provided for the project entitled: ‘Development of a universal model for testing pharmacokinetics of therapeutic monoclonal antibodies at the pre-clinical trial stage using the domestic pig model’. The value of the granted aid was PLN 1,587,119.30. The total cost of project implementation is PLN 2,818,986.49.
The purpose of the project is to develop a universal model for testing monoclonal antibodies at the pre-clinical trial stage using the domestic pig model with induced immunotolerance for human therapeutic monoclonal antibodies (mAb). The project involves R&D work aimed at developing a new animal model based on the domestic pig with induced immunotolerance for human therapeutic monoclonal antibodies.
The result of the project will enable a more rapid optimisation of the pre-clinical trial stage and will contribute to shorter time-to-market. The result of the project will be characterised by a high potential for commercialisation and will respond to the needs of pharmaceutical manufacturers who intend to develop biotechnological drugs.
Co-funding was provided for the project entitled: ‘Development of an innovative technology for manufacturing a monoclonal antibody used for the treatment of multiple sclerosis’. The value of the granted aid was PLN 19,980,826.34. The total cost of project implementation is PLN 49,952,065.84.
The project’s objective is to present a production technology for a monoclonal antibody using CHO cell lines, followed by the commencement of the production of a biosimilar drug used in the treatment of multiple sclerosis, whose reference biological drug is manufactured using NS0 mouse cell lines. The development work planned in the project will include a shift from the production of protein on a medium scale (50 L) to full-scale production, applying GMP standards (1,000 L), while devising analytical and biological methods.
The process innovation planned for implementation on the basis of the project’s results will facilitate more efficient production of a biosimilar that will be safe to use (a smaller risk of immunogenic action of an antibody than with the reference drug). Additionally, the new technology developed as part of the project will make it possible to achieve 5 to 10 times greater efficiency in the manufacturing process in comparison to the NS0 cell line. By optimising the protein production process, it will be possible, among other things, to reduce the amount of process materials, culture media and additional media components used. Increased process efficiency will lead to lower production costs, which combined with price pressure from legislation and the introduction of generic substitutes, will significantly reduce the cost and increase the availability of multiple sclerosis treatment using biopharmaceuticals.