Immunotherapy drugs are human cells that are reprogrammed in the laboratory to attack life-threatening cancer cells in the body. Unlike the drugs designed for cancer patients used today, which include chemotherapy and radiotherapy, they allow targeted action against cancer.
"The production of advanced and gene therapy medicines is very demanding and requires not only professional skills but also a deep understanding of the Good Manufacturing Practice system, which ensures high quality medicines throughout the European Union. Our experts from ÚHKT will not only impart theoretical knowledge of the field to the students of the Faculty of Biomedical Engineering of the CTU, but also plan to create a quality system in which trained students will be able to actively participate in the demanding work in clean rooms and the production of evaluated medicines for modern therapies," said Dr. Petr Lesný, team leader of ÚHKT.
The project will launch a new unique elective course "Cleanrooms and Good Practices for Advanced Therapeutics" in the winter semester of 2021, which emphasizes state-of-the-art knowledge in this area. The course will be a two-semester course and will be designed so that if there is a need for skilled workers in the production of immunotherapy products, CTU FBMI can quickly start block teaching.
It is planned to use the super-clean premises in the CTU FBMI building, the reconstruction of which for the needs of production will begin in the autumn. "The Faculty of Biomedical Engineering is the only faculty in the Czech Republic that not only can offer such a highly specialized subject, but is also unique in that it has the technology and facilities for the production of immunotherapeutic drugs. Our goal is to obtain state approval for production, and therefore we greatly appreciate the cooperation with the Institute of Human Immunotherapy, which is the only institute in the Czech Republic to have this state approval," adds Prof. Jozef Rosina, M.D., Ph.D., MBA, Dean of the Faculty.
The partner of the project is BLOCK CRS, which, within the framework of the TA ČR GAMA project, started in 2019 together with ÚHKT the cooperation on the design of production equipment for gene therapy and work with viral vectors.
Thanks to the cooperation between FBMI and the team of experts from the practice of manufacturing modern therapeutic drugs from ÚHKT, the availability of gene therapy for haemato-oncology patients in the Czech Republic will increase and at the same time there will be enough experts with knowledge of modern pharmaceutical manufacturing processes available in the Czech Republic.