Biotechnology Development at ICGEB

Serbia-Italy cooperation project for the production of therapeutic monoclonal antibodies

A new technology transfer project, MabTHER, has been established to strengthen Serbia’s capacity to develop monoclonal therapeutic antibodies (Mab).

The project, generously supported by the Autonomous Region of Friuli Venezia Giulia, involves the ICGEB Biotechnology Development Unit BDU with more than 25 years’ experience in providing Member States with resources and know-how to expand the availability of, and access to, quality life-saving biotherapies.

The Agreement was signed at the Regional headquarters in Trieste by ICGEB Director-General Dr. Lawrence Banks, and Councillor Alessia Rosolen, Regional Councillor for Labor, Training, Education, Research, University and Family. Also present for the occasion was Dr. Natasa Skoko, Head of the BDU in Trieste, and Dr. Zana Bojic-Trbojevic, partner from the Institute for the Application of Nuclear Energy INEP. The MabTHER initiative focuses on knowledge transfer for the development and production of the Mab biosimilar Trastuzumab (a monoclonal antibody used to treat breast and stomach cancer).

The direct beneficiaries of the project include Serbian researchers and officials at INEP who will be supported in acquiring the necessary skills for successful technology transfer. A 6-week practical technology transfer course will follow, at the BDU in Trieste, Italy, where the researchers will gain advanced knowledge and skills in different aspects of the Trastuzumab biosimilar manufacturing process.

The Technology transfer will be followed by BDU staff assisting researchers in replicating the Trastuzumab manufacturing process in Serbia, making use of local facilities and in collaboration with local industries. Overall, the project is expected to last 12 months.

“Building local manufacturing capacity and skills is a cornerstone for job creation, wealth and local stability-” said Dr. Banks. “This pilot initiative involves the transfer of technologies that the ICGEB has developed over many years of optimization so that biotherapeutics that meet all FDA and European Pharmacopoeia standards can be transferred to the Serbian industry. These products can then be produced and marketed locally at a price significantly lower than those of usual international supply chains, thus making health care more affordable for local populations, while creating jobs and manufacturing capacity in Serbia and surrounding areas.”

Councillor Rosolen stated that “In addition to the scientific aspect, the production of low-cost drugs in Serbia touches a central issue for the regional administration: social sustainability”, adding that “Sharing knowledge and production techniques of these drugs with other nations pertaining to our territorial area, such as the Balkans, makes it possible to overcome the inequalities produced by the pharmaceutical market and produces positive effects, strengthening international cooperation and collaboration.”

The long-term goal of this project is to develop capacity and strengthen expertise to produce biosimilars in Serbia, as well as to consolidate the cooperation relationship of the Autonomous Region of Friuli Venezia Giulia in the area.

The spin-offs of the MabTHER project will allow improvement of the skills of Serbian research institutions in the production of biosimilar drugs, increasing opportunities for the development of low-cost, community-accessible products, as well as provide the technology for the production process of Trastuzumab and the reproducibility and “scale-up” of activities at INEP.

It will also provide an opportunity to deepen the collaboration between ICGEB, INEP and the industrial partner, which will lead to new projects for the joint development of additional biosimilar drugs.