Vol 6, No 2 (2024)

This research is devoted to the pressing issue of improving the microbiological monitoring of the production environment and quality control of products in the pharmaceutical and biotechnological industries. It is emphasized that these industries are currently among the most profitable sectors of the Russian economy, but their manufactured products are subject to particularly high quality requirements. The modern operating conditions of these enterprises give rise to certain problems that require a standardized approach to their solution. In this regard, the task of improving the microbiological monitoring of the production environment, as well as quality control of products, becomes particularly relevant in order to optimize production processes and increase the level of safety of the manufactured goods. The paper proposes an approach to the identification and analysis of critical points of production, depending on the sources of potential microbial contamination. For each of the identified critical points, an analysis of potential problems has been carried out, the solution of which will make it possible to increase the effectiveness of the microbiological control system.

Survival rate calculations for liver cancer patients at the federal level in the Russian Federation are only conducted in the North-Western Federal District and a few other individual administrative territories. In the first part of our study, we presented a detailed analysis of the prevalence of liver cancer, noting that the levels of standardized incidence and mortality rates in Russia and the North-Western Federal District are virtually identical, allowing us to consider the results of our study as nationally representative. The conducted research confirmed the seriousness of the issue of liver cancer among the population. However, certain advancements in patient treatment were recorded, with a significant increase in survival rates, primarily for one-year survival. For example, in the North-Western Federal District, one-year survival increased from 13.6% in 2000 to 23.1% in 2022, representing a 69.8% increase. At the same time, five-year survival rates remained largely unchanged. Increases in survival rates were observed in most age groups. A significant deficiency in the initial patient record-keeping was identified - insufficiently accurate determination of the stage of liver cancer. One-year survival rates for male and female liver cancer patients (22.7% and 22.1%) were nearly equal, as were the survival rates for liver cancer patients residing in urban and rural areas. Therefore, further improvement in the outcomes of treatment for this complex patient group can only be achieved through the implementation of regional and federal screening and epidemiological surveillance programs among populations at high and extremely high risk of developing hepatocellular carcinoma. 

The present review is devoted to such biotechnologically interesting polymers as chitin and chitosan, which form the cuticle of arthropods and the core of fungal cell wall. Chitosan is a linear polysaccharide containing D-glucosamine and N-acetyl-D-glucosamine residues, which has valuable biological properties. It is a product of deacetylation of chitin. Possessing pronounced muco-adhesive properties and controlled release ability, the chitosan is widely used in delivery of various therapeutic agents, such as anticancer drugs, antibiotics, proteins, nucleic acids, etc. Chitosan nanoparticles, micro- and nanocapsules, as well as hydrogels, can be developed for targeted delivery of drugs to specific organs and tissues. Initially, the attention of biotechnologists was focused on animal chitin, and basic methods for extracting and purifying this biopolymer took shape at this stage. Despite the complexity of the organization of the arthropod cuticle, the chitin in it is not covalently bound to other linear biopolymers and is organized into nanofibrils that form a fairly homogeneous matrix, therefore it is easier to extract than from the mycelium mass of fungi, where this biopolymer is tightly packed into microfibrils bound to the glucan matrix. The main stages of chitin extraction and its further modification into chitosan are deproteinization, demineralization, deacetylation, and the main methods of chitosan purification are filtration, dialysis and reprecipitation. After isolation, chitosan should be dried. To extract chitin from the fungi, the above classical chemical methods are often combined with the methods of “green chemistry” and industrial microbiology. The profitability of the production of chitin/chitosan from crustaceans and edible mushrooms is approximately at the same level. The cost of mushroom products can be reduced by using agricultural or forestry waste as nutrient substrates. This makes the use of fungi as sources of chitin/chitosan in forest regions rather promising.

The main sources of entry of pharmaceutical drugs and their active metabolites into drinking water are the pharmaceutical products consumed by the population, which are discharged through the sewage system, the effluents from pharmaceutical and medical organizations, as well as the by-products of agriculture, which ultimately form wastewater that passes through insufficiently effective treatment systems. The study is devoted to the development of approaches to the formation of a list of pharmaceutical products and their metabolites subject to state regulation. The importance of strengthening control over the use of such substances and conducting additional assessments of their negative impact on the environment is emphasized. In the course of the work, a comparative analysis of the active components in the top 20 best-selling pharmaceutical products on the Russian market was carried out using Russian and international literature sources. Regulatory legal acts regulating the classification of antibiotics and hormones by the degree of danger have been studied. Based on this, a preliminary list of medicinal substances that can potentially have a negative impact on the environment has been formed, mainly in accordance with the requirements of SanPiN 1.2.3685-21. The results of the study can be used for further assessments of the harmful effects of these substances and the development of measures for their regulation

The essay is dedicated to Professor, Doctor of Pharmaceutical Sciences Susanna Alexandrovna Minina – an outstanding scientist, gifted educator, and remarkable person. Professor Minina's professional career was closely connected with the Saint Petersburg State and Chemical and Pharmaceutical University. Her reminiscences of studying and working at the Leningrad Chemical-Pharmaceutical Institute from 1948 to 1968 are provided. Here, Professor S.A. Minina studied, then taught and headed the Department of Drug Technology and Phytopreparations from 1968 to 1994. She is the author of over 350 scientific papers, 31 author's certificates, and 5 patents, as well as 36 methodological developments. Susanna Alexandrovna Minina carried out significant work in training scientific personnel. Under her guidance, 40 candidate dissertations were successfully defended, and she also served as a scientific consultant in two doctoral dissertations. The students and followers of Professor Minina are successfully engaged in professional activities not only in Russia but also abroad. The main directions of S.A. Minina's scientific research included the development of technologies for phytopreparations and the creation of pharmaceutical forms based on substances of synthetic and natural origin. The results of her research have been implemented in industrial regulations for the production of drugs currently used in the pharmaceutical industry. The scientific and pedagogical activities of Susanna Alexandrovna Minina have been honored with government awards, including badges of distinction "Excellent of Healthcare" and "Excellent of Medical and Microbiological Industry of the USSR". S.A. Minina was awarded a diploma and a gold honorary medal of the Academy of Natural Sciences "For a practical contribution to the nation's health". We express special thanks to Alexander Borisovich Zaputryaev, the son of Susanna Alexandrovna, for assistance in summarizing archival materials provided from the family archive.