V. V. Mashin, A. N. Sergeev, N. N. Martynova, A. N. Galiullina, O. G. Yakin, A. Yu. Grosheva, T. I. Glotova, V. V. Kataeva, N. V. Zagidullin
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引用次数: 0
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.
期刊介绍：
Pharmaceutical Chemistry Journal is a monthly publication devoted to scientific and technical research on the creation of new drugs and the improvement of manufacturing technology of drugs and intermediates. International contributors cover the entire spectrum of new drug research, including:
methods of synthesis;
results of pharmacological, toxicological, and biochemical studies;
investigation of structure - activity relationships in prediction of new compounds;
methods and technical facilities used; and
problems associated with the development of ecologically safe and economically feasible methods of industrial production.
In addition, analytical reviews of the international literature in the field provide coverage of the most recent developments around the world.
Pharmaceutical Chemistry Journal is a translation of the Russian journal Khimiko-Farmatsevticheskii Zhurnal. The Russian Volume Year is published in English from April.
All articles are peer-reviewed.
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