Validation Studies of Some Stages of Drug Production from Equine Blood Plasma Regarding the Reduction of Extraneous Viruses

Abstract

Russian and foreign pharmacopoeias require at least two stages in the manufacturing process of medicinal products based on animal serum-plasma to provide at least a 4-log decrease in the concentration of extraneous viruses to minimize the risk of viral contamination in the corresponding intermediates after each stage. The enzymolysis and thermal denaturation stages involved in the production of drugs based on equine blood plasma were validated for reduction of model enveloped viruses in influenza (RNA-containing) and smallpox vaccine (DNA-containing). Both stages were shown to provide the required level of inactivation of these model viruses in the corresponding drug intermediates, significantly minimizing the risk of their contamination with enveloped viruses.