SCALING COWPOX VACCINE PRODUCTION TECHNOLOGY: FROM DEVELOPMENT TO GMP STANDARDS

This paper presents a comprehensive analysis and systematization of the key stages of scaling the technological chain of production of cowpox vaccine, with an emphasis on the full-scale adaptation of production processes to strict criteria of good manufacturing practice (GMP). Special attention is paid to the detailed validation of all key stages, including virus cultivation, vaccine formation, lyophilization process and comprehensive quality control of the final product. Validation of key processes was carried out with careful elaboration of virus culture protocols, which included the use of the Nunc Cell Factory, ensuring high stability and reproducibility of the procedure. The introduction of improved methods of microbiological purity control at all stages of production, including regular checks for the presence of microorganisms and monitoring of environmental parameters, contributed to improving the reliability of the production process. Operational standardization was achieved through the integration of real-time systems for data monitoring and analysis, which helped minimize human error and improve production accuracy. As a result, key optimization strategies have been identified and implemented to improve production efficiency, including improving automation processes and digitalizing production lines. The results of the study represent a significant step forward in the development of veterinary vaccinology, providing a reliable basis for future developments and innovations in the field of prevention and treatment of infectious diseases in farm animals. The work highlights the importance of an interdisciplinary approach combining biological, engineering, and management competencies to achieve high standards of vaccine quality and safety. In light of the emerging challenges associated with changes in legislation and the development of new technologies, this work offers a platform for continuing research in the field of biotechnology and vaccine production aimed at adapting to the dynamic conditions of the veterinary industry.