Modern approaches to bioanalytics and pharmaceutical development: lectures by specialists from «ЦФА» LLC in the SKMA

Timofey Nikolaevich Komarov, d. of pharm. sc. and Director of the Research Center at the «Центр Фармацевтической Аналитики» LLC, is currently on a working visit to the Department of Pharmaceutical and Toxicological Chemistry at the South Kazakhstan Medical Academy. The visit included lectures and discussion sessions on current trends in bioanalytics, quality control, and pharmaceutical development.

In addition to T. N. Komarov's lecture course, leading employees of the «Центр Фармацевтической Аналитики» LLC, P. K. Karnakova, D. S. Shchelgacheva, N. S. Bagaeva, and M. O. Popova, as well as I. E. Shokhin, General Director of the Pharmaceutical Analytics Center, participated in the educational process and conducted a series of thematic lectures for the audience online.
The lecture series covers a range of interconnected areas reflecting modern approaches to organizing and conducting bioanalytical research. The lectures cover the operating principles of a modern bioanalytical center, including structural models of analytical units, requirements for their architecture and zoning, and the fundamentals of building and maintaining a quality management system. Particular attention is paid to the standardization of analytical processes, ensuring data traceability, and integrating laboratory research into the overall pharmaceutical development system; these aspects were illustrated with a video presentation of the laboratory infrastructure of the digital analytical laboratory.
A significant portion of the lecture material is devoted to bioanalytical support for drug development and registration, in particular the methodological foundations of comparative dissolution kinetics and its role in substantiating pharmaceutical equivalence and interchangeability of drugs. Current regulatory approaches in the EAEU to assessing dissolution profiles, principles for selecting mathematical models and comparability criteria, and the potential for using the obtained data in the development and maintenance of registration dossiers are discussed. Sample preparation and analytical evaluation of biological samples are covered separately. Participants were presented with a systems analysis of the preanalytical stages of biospecimen processing, including the preparation of biological fluids, control of sources of analytical variability, and measures to reduce the likelihood of errors. Both fundamental theoretical principles and practical solutions applied in clinical and biopharmaceutical research are considered.
A separate section of the lecture course examines modern bioanalytical research methods, with an emphasis on ligand-binding analytical approaches and the specific application of commercial test systems. This section provides a detailed discussion of their validation requirements, as well as key parameters determining the reliability, reproducibility, and sensitivity of methods, and criteria for their compliance with current international and regional regulatory requirements.

The development of scientific publication activity is also being discussed. The Center for Pharmaceutical Analytics, LLC, is the founder of two specialized journals: "Development and Registration of Medicines" and "Herbarium." Timofey Nikolaevich presented the journals' editorial policies and outlined opportunities for academy staff to participate in publication projects aimed at advancing pharmaceutical science and botanical and pharmacognostic research.

The visit by Dr. T.N. Komarov makes a significant contribution to strengthening academic and scientific-practical ties. Lectures and discussions expand the participants' professional competencies, introducing them to current technologies and modern approaches used in bioanalytics and pharmaceutical development.