Development and Standardization Strategy for Quality Control of a Recombinant Capripoxvirus-Vectored Vaccine Against Brucellosis

This work presents the development and implementation of a quality control and standardization strategy for a recombinant capripoxvirus-vectored vaccine against brucellosis. We conducted a comprehensive analysis of World Health Organization guidelines, the State Pharmacopoeia of the Republic of Kazakhstan, and regulatory documents governing quality control of biological medicinal products. Based on this analysis, we established a comprehensive panel of quality parameters encompassing physicochemical, molecular-genetic, biological, and microbiological characteristics of the vaccine, as well as assessment of residual process-related impurities. Using the developed strategy, we evaluated three pilot batches of the recombinant capripoxvirus-vectored brucellosis vaccine. The results demonstrated that all pilot batches met the established quality and safety requirements. The developed quality control and standardization strategy provides a foundation for further refinement of the evaluation system for recombinant vector-based brucellosis vaccines and for the preparation of regulatory documentation to support their clinical application.