Development of a Unified Risk Analysis Protocol for a Production of Biotechnological Active Pharmaceutical Substance

Abstract for the thesis on the topic "Development of a unified protocol for risk analysis in the production of biotechnological AFS". Author: Zinchenko Gleb Valentynovich, 4th year student of the Faculty of Biology and Biotechnology of the Higher School of Economics The work includes: 42 pages, 9 tables, 2 figures. Number of sources: 26. Keywords: risk analysis, active pharmaceutical substance, pharmaceutical quality system. The aim of the work is to develop a form of a unified risk analysis protocol that can be used to identify and analyze possible risks in order to assess the impact of key factors in the biopharmaceutical production of various AFS. The research part consists in finding a suitable method for determining risks, collecting information about relevant similar risks in pharmaceutical industries, and developing the structure and form of the protocol. As part of the work, the main stages of obtaining biotechnological AFS are investigated. Based on the literature, the analysis of various methods of risk identification is carried out. The study identified and assessed risks of various nature, including risks of cross-contamination, risks associated with personnel, as well as general technical and technological risks. A form of a unified protocol for risk analysis has been developed with an emphasis on the main stages of the biotechnological production process. Using the developed form, a risk analysis was carried out in relation to the production of the biotechnological AFS "Etanercept" at Sputnik Technopolis LLC. According to the results of the risk analysis, it was found that the risks in the production of the drug "Etanercept" at the production site are minimal, additional risk reduction measures are not required. The developed form includes in the field of analysis all significant factors and parameters that can affect the quality of the final product of the analyzed production. The results obtained can be used in various pharmaceutical industries at the risk identification stage to identify and analyze significant factors and their degree of influence on the quality of the final product. The risk analysis protocol developed during the study can also be used in Sputnik Technopolis LLC in relation to other manufactured products.