Methodology of Teaching an Academic Discipline "Standardization of Medicinal Products of Biotechnological Origin"

Abstract

The purpose of the article is to highlight the relevance of the methodology for teaching the academic discipline "Standardization of Medicinal Products of Biotechnological Origin", the features of analytical procedures during the analysis of such products by standardized methods, and the introduction of specific definitions into the educational and methodological complex of the discipline in order to modernize it and enhance the effectiveness of understanding the material by higher education students in Ukraine in accordance with the educational program "Industrial and Pharmaceutical Biotechnology" of the second (master's) level of higher education in the specialty G21 "Biotechnology and Bioengineering". Methods: analytical, systematic, and logical. Results. Medicinal products of biotechnological origin (BMPs) are drugs whose active substance is produced using living organisms or biological systems through modern biotechnology methods (recombinant DNA technology, hybridoma method, tissue engineering). The main groups of BMPs include recombinant proteins, monoclonal antibodies, blood clotting factors, erythropoietins, vaccines, and gene and cell therapy products. The principal differences between BMPs and synthetic and semi-synthetic medicinal products lie in their large molecular weight, complex spatial structure, heterogeneity, and sensitivity to external influences. This determines increased requirements for quality control in accordance with international ICH guidance documents (Q6B, Q5A–Q5E, Q2(R2), Q1A–Q1F). The introduction of the following definitions into the educational material is proposed: proving similarity, comparison with a reference drug, standardization of analysis methods and validation, comprehensive analytical and functional analysis, and confirmation of a high degree of similarity. Conclusions. The methodology of teaching the discipline is a combination of approaches, methods, and interactive tools that ensure the effectiveness of the learning process. The discipline expands students' knowledge of the procedure for pharmaceutical analysis of BMPs using standardized methods with appropriate validation procedures. Further harmonization of scientific research with European achievements ensures the implementation of new analytical methods for confirming the quality of medicinal products.