Setting up clinical and production-based biobanks in the healthcare system of the Russian Federation

Background. The therapeutic efficacy of skin grafts and various tissue equivalents in the treatment of many diseases is known. Special clinical biobanks are engaged in the procurement of such products, their processing, storage, provision of their safety measures, and preparation for use. The purpose of such biobanks is both the storage of tissues and cells and their subsequent delivery to medical institutions for the clinical use. The production-based biobanks allow the use of biomaterial for the manufacture of drugs and medical devices and are also an important component in the organization of medical care in many countries of the world. Objectives. To summarize the current concepts on the role of clinical and production-based biobanks in the system of providing medical care to the population in various countries of the world; to present the organizational and legal mechanisms of the tissue banking system using the example of the USA and the EU; to present solutions for creating the first biobanks of viable tissues in the Russian Federation using the example of a skin biobank. Material and methods. The review includes world literature publications on tissue banks, references to legal acts and documents regulating tissue donation in Russia and other countries, as well as issues of organizing the work of biobanks. Conclusion. This article introduces an overview of biological banking practices, the main types of grafts and tissue equivalents of skin, the areas of their possible use and the peculiarities of processing and storage technology. The discussion presents an opinions on what types of tissue banks can be created now to meet urgent medical needs, what products can be processed and stored in such banks, and what regulatory framework is required for their creation and operation.