First Russian GMP-Laboratory of Cell Technologies Opened in Obninsk
On January 20, on the basis of the Medical Radiological Research Center named after A.F. Tsyba, a branch of the Federal State Budgetary Institution National Medical Research Center for Radiology of the Russian Ministry of Health, hosted the grand opening of an innovative research and production complex for GMP-class cell technologies, including a bone marrow transplantation department in Obninsk.
The event was attended by: Mikhail Murashko, Minister of Health of the Russian Federation, Alexei Likhachev, Director General of the Rosatom State Corporation, Andrey Kaprin, Director General of the National Medical Research Center for Radiology of the Ministry of Health of Russia, Sergey Ivanov, Director of the Medical Radiological Research Center named after A.F. Tsyba, Vladislav Shapsha, Governor of the Kaluga Region.
One of the key tasks of the new complex is to develop and implement the latest cell therapy products for cancer treatment. The biotechnological products for protection against toxic damage, special diagnostic panels, tissue engineering structures and bioprostheses are to be produced in the future. The highest level of technical equipment makes it possible to solve here the widest range of special tasks related to biological protection and safety.
The development, production and use of high-tech drugs based on human cells are complex both from a medical point of view and from the point of view of industrial pharmacy. By decision of the Council of the Eurasian Economic Commission, dosage forms, including not only pharmaceutical substances, but also living human cells, are classified as “drugs based on somatic cells.” This class of drugs requires special technological equipment for production and quality control and is extremely sensitive to compliance with special storage and transportation conditions.
The boxes of the complex are designed for four high-tech drugs based on human cells produced isolated with no production lines intersected. The complex has its own biobank, a laboratory for finished dosage forms and quality control, its own water treatment and autoclaving facilities.
According to Andrey Kaprin, a special advantage of the complex is the in-house GMP production to support domestic healthcare in solving acute issues of import substitution of drugs to treat orphan diseases, and produce finished dosage forms and biotechnological products for personalized therapy. “It is a great achievement of the created research and production complex that it is close to the ‘sick bed’, which is critical for some complex expensive products to be used, for example, CAR-T cell therapy drugs,” Andrey Kaprin, the academician of the Russian Academy of Sciences, noted.