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The production of vaccines must comply with the quality management regulations for pharmaceutical production. Any vaccine preparation must undergo rigorous testing in a standardized quality inspection system to ensure the safety and effectiveness of the vaccine, so as to maximize the efficiency of the effect after vaccination. Reduce adverse reactions after immunization. Regardless of the scale of production, there must be a quality assurance agency and a quality appraisal agency.
Different detection means can be used depending on the vaccinogen, such as protein assay, nucleic acid assay, polysaccharide spectrometry, and the like. Various gel electrophoresis techniques, agarose gel electrophoresis, Western blotting and other techniques to determine the relative molecular mass and immunological properties of important vaccinogens; isocratic focusing techniques to determine the isoelectric point of vaccine components; biomarker technology for vaccine to determine the degree of glycosylation of the protein component.
The culture method is used to detect the contamination of microorganisms such as bacteria and mycoplasma. The tissue culture and electron microscopy techniques are used to detect the presence of virus contamination. The pure bacteria test detects the number of live bacteria, the total amount of bacteria and the total bacterial amount of the live bacteria of the live attenuated vaccine. The presence of other bacteria. The activity of bacterial toxin was detected by CHO cytotoxicity test and HeLa cytotoxicity test, and virus activity was detected by tissue culture method, cell infection effect, and plaque forming unit test.
It mainly identifies the immunogenic characteristics of vaccinium.
In vitro identification techniques: such as agglutination test, immunoprecipitation test, diffusion test, immunoelectrophoresis test, various ELISA techniques, immunofluorescence technology, Western blotting, etc. to detect the immunogenicity and immunoreactivity of important components of the vaccine.
In vivo identification: mainly refers to animal experiments. Various immunological indicators are detected after inoculation of the animal to determine the effect of the vaccine, and the adverse reactions and toxic effects of the vaccine can also be observed. Commonly used experimental animals for the detection of vaccines include mice, white rabbits, guinea pigs, hamsters, chickens, geese, primates, sheep, and horses.
Standardization of Vaccinogen
The meaning of standardization: biological agents contain major and non-essential components, the former must exist in a quantitative form so that it makes sense to carry out and maintain treatment. In addition, biological agents must also determine their fixed total biopotency. WHO encourages and advocates the use of standardized vaccines as much as possible. Standardization is an important means of maintaining high-quality vaccines. The quality of standardized preparations is very important for the effectiveness of specific treatments.Steps and objectives for standardization of immunogenic antigens.
Tetanus. Geneva, (1993) ‘The immunological basis for immunization.’ World Health Organization, (unpublished document WHO/EPI/Gen/93.13).
Julien Peetermans, Production, (1992) ‘quality control and characterization of an inactivated hepatitis A vaccine’, Vaccine, 10(1), S99-S101.
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