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.
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References
Rules of carrying out researches of biological medicines of the Eurasian Economic Union, Chap. 4 (2016).
V. V. Mashin, A. N. Sergeev, N. N. Martynova, et al., Khim.-farm. Zh., 56(2), 55 – 59 (2022).
V. V. Mashin, A. N. Sergeev, N. N. Martynova, et al., Khim.-farm. Zh., 56(4), 59 – 64 (2022).
A. V. Beilinson, “Sera,” in: Multivolume Guide to Microbiology, Clinic, and Epidemiology of Infectious Diseases [in Russian], Vol. 3, Medgiz, Moscow (1964).
MU 3.3.2.1758-03 Methods for determining the quality indicators of immunobiological preparations for the prevention and diagnosis of influenza, Moscow (2003).
L. Zaks, Statistical Evaluation [in Russian], Statistika, Moscow (1976).
WHO Guidance document on viral inactivation and removal procedure intended to assure the viral safety of blood plasma products, WHO Technical Report, Series No. 924, Annex 4 (2004).
CPMP / 268 / 95, Virus validation studies: The design, contribution and interpretation of studies validating the inactivation and removal of viruses, Committee for Proprietary Medicinal Products (CPMP) (1996).
C. P. Caricati, L. Oliveira-Nascimento, J. T. Yoshida, et al., Biotechnol. Prog., 29, 972 – 979 (2013); https://doi.org/10.1002/btpr.1758.
M. Farmer, A. Ebeling, T. Marshall, et al., Biomater., Artif. Cells, Immobilization Biotechnol., 20(2–4), 429 – 433 (1992); https://doi.org/10.3109/10731199209119663;PMID:1327242.
N. N. Savina, A. A. Ekimov, V. P. Trukhin, et al., Med. Ekstrem. Situatsii, No. 3 (2021); https://doi.org/10.47183/mes.2021.032.
N. N. Savina, A. A. Ekimov, M. A. Shuklina, et al., Med. Ekstrem. Situatsii, No. 4 (2022); https://doi.org/10.47183/mes.2022.047.
H. Dichtelmuller, D. Rudnick, B. Breuer, et al., Biologicals, 21(3), 259 – 268 (1993); https://doi.org/10.1006/biol.1993.1083.
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Translated from Khimiko-Farmatsevticheskii Zhurnal, Vol. 57, No. 12, pp. 38 – 42, December, 2023.
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Mashin, V.V., Sergeev, A.N., Martynova, N.N. et al. Validation Studies of Some Stages of Drug Production from Equine Blood Plasma Regarding the Reduction of Extraneous Viruses. Pharm Chem J 57, 1994–1997 (2024). https://doi.org/10.1007/s11094-024-03106-0
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DOI: https://doi.org/10.1007/s11094-024-03106-0