DEVELOPMENT AND STANDARDIZATION STRATEGY FOR QUALITY CONTROL OF A RECOMBINANT CAPRIPOXVIRUS-VECTORED VACCINE AGAINST BRUCELLOSIS
Main Article Content
Authors
K.K. Jekebekov
Research Institute for Biological Safety Problems, National Holding “QazBioPharm”, 25/1, Gvardeiskiy, Korday District, Zhambyl Region, 080409, Kazakhstan
S.U. Moldagulova
Research Institute for Biological Safety Problems, National Holding “QazBioPharm”, 25/1, Gvardeiskiy, Korday District, Zhambyl Region, 080409, Kazakhstan
A.S. Zhakypbek
Research Institute for Biological Safety Problems, National Holding “QazBioPharm”, 25/1, Gvardeiskiy, Korday District, Zhambyl Region, 080409, Kazakhstan
Ye.A. Shayakhmetov
Research Institute for Biological Safety Problems, National Holding “QazBioPharm”, 25/1, Gvardeiskiy, Korday District, Zhambyl Region, 080409, Kazakhstan
A. Ulankyzy
Research Institute for Biological Safety Problems, National Holding “QazBioPharm”, 25/1, Gvardeiskiy, Korday District, Zhambyl Region, 080409, Kazakhstan
Zh.S. Absatova
Research Institute for Biological Safety Problems, National Holding “QazBioPharm”, 25/1, Gvardeiskiy, Korday District, Zhambyl Region, 080409, Kazakhstan
G.D. Nakhanova
Research Institute for Biological Safety Problems, National Holding “QazBioPharm”, 25/1, Gvardeiskiy, Korday District, Zhambyl Region, 080409, Kazakhstan
E.Zh. Kalimolda
Research Institute for Biological Safety Problems, National Holding “QazBioPharm”, 25/1, Gvardeiskiy, Korday District, Zhambyl Region, 080409, Kazakhstan
E.P. Voronina
Research Institute for Biological Safety Problems, National Holding “QazBioPharm”, 25/1, Gvardeiskiy, Korday District, Zhambyl Region, 080409, Kazakhstan
T.I. Baiseit
Research Institute for Biological Safety Problems, National Holding “QazBioPharm”, 25/1, Gvardeiskiy, Korday District, Zhambyl Region, 080409, Kazakhstan
A.D. Omurtay
Research Institute for Biological Safety Problems, National Holding “QazBioPharm”, 25/1, Gvardeiskiy, Korday District, Zhambyl Region, 080409, Kazakhstan
S.O. Sadikaliyeva
Research Institute for Biological Safety Problems, National Holding “QazBioPharm”, 25/1, Gvardeiskiy, Korday District, Zhambyl Region, 080409, Kazakhstan
E.A. Bulatov
Research Institute for Biological Safety Problems, National Holding “QazBioPharm”, 25/1, Gvardeiskiy, Korday District, Zhambyl Region, 080409, Kazakhstan
Zh.T. Amanova
Research Institute for Biological Safety Problems, National Holding “QazBioPharm”, 25/1, Gvardeiskiy, Korday District, Zhambyl Region, 080409, Kazakhstan
K.A. Shorayeva
Research Institute for Biological Safety Problems, National Holding “QazBioPharm”, 25/1, Gvardeiskiy, Korday District, Zhambyl Region, 080409, Kazakhstan
S.Sh. Nurabayev
Research Institute for Biological Safety Problems, National Holding “QazBioPharm”, 25/1, Gvardeiskiy, Korday District, Zhambyl Region, 080409, Kazakhstan
O.V. Chervyakova
Research Institute for Biological Safety Problems, National Holding “QazBioPharm”, 25/1, Gvardeiskiy, Korday District, Zhambyl Region, 080409, Kazakhstan
Abstract
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.
Keywords
recombinant vaccine, quality control, standardization, brucellosis, capripoxvirus.
Article Details
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