Safety and Immunogenicity of Fully Liquid Hexavalent DTaP-IPV-HepB-Hib Vaccine in Healthy Infants in Russian Federation

Relevance. The production and quality control of any drugs are strictly regulated. In the case of antiviral vaccines, the requirements for their safety and protective activity are getting tougher every year. Vaccine manufacturers face three tasks: ensuring high immunogenicity, safety and availability of the drug. During the development and production of immunobiological drugs, manufacturers must demonstrate sufficient purification from technological impurities to ensure the purity of the drug. Technological impurities directly depend on the technological process and the expression systems used. The Vero cell line has been widely used in the production of various antiviral vaccines for many decades. Thus, the improvement of technological processes for the purification of vaccine preparations from proteins and DNA of Vero cells is still matter of current interest.Aims. Selection of resins and reagents for ion exchange chromatography to reduce the amount of technological impurities in the inactivated polio vaccine production.Materials and Methods. To obtain viral suspensions, producer cultures were infected with poliovirus type 1 (Sabin strain LSc 2ab), type 2 (Sabin strain P712 Ch 2ab), and type 3 (Sabin strain Leon 12a1b). Multiplicity of infection was 0.02 ± 0.01 TCD50/cell. To evaluate the efficiency of ion-exchange chromatography we determined the degree of purification of fractions from ballast proteins, the degree of purification of fractions from residual cellular DNA, and the degree of extraction of the target antigen using specific formulas.Results and discussion. More than 80 experiments have been performed to purify type 1, type 2, and type 3 poliovirus concentrates using various sorbents. In quality control of purified concentrates of type 1, type 2 and type 3 polioviruses, in addition to analysis for total protein, an analysis was performed for the presence of Vero cell proteins.Conclusion. The use of the proposed modifications of purification of concentrates of Sabin strains of poliovirus types 1, 2 and 3 using ion exchange chromatography allows to obtain inactivated viral products that meet the requirements of WHO and the European Pharmacopoeia both in biochemical parameters (the content of host-cell DNA and the content of ballast proteins, including host-cell proteins) and specific activity (D-antigen content). Furthermore, additional purification of vaccines using ion exchange chromatography allows to reduce the content of residual cellular DNA to almost zero, which makes the inactivated polio vaccine the most attractive for its inclusion in various combined vaccines.

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Safety and Immunogenicity of Fully Liquid Hexavalent DTaP-IPV-HepB-Hib Vaccine in Healthy Infants in Russian Federation

Cited by 2 publications

References 26 publications

DTaP-IPV-HB-Hib vaccine (Hexaxim): an update 10 years after first licensure

DTaP-IPV-HB-Hib vaccine (Hexaxim): an update 10 years after first licensure

Application of Ion Exchange Chromatography in the Development of Technology to Obtain Inactivated Poliovirus Vaccine

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