Method for producing rabies vaccine

Abstract

The invention discloses a method for producing a rabies vaccine. The method comprises the following steps: (1) culturing a rabies virus, and preparing a virus collection liquid; (2) purifying the virus, and preparing vaccine stoste; (3) mixing the vaccine stoste with auxiliary materials, so as to obtain the vaccine, wherein virus deactivation is carried out before or after the step (2); the step of virus purification in the step (2) comprises steps of anion exchange chromatography and hydroxyapatite and chromatography of which the sequences can be exchanged. By adopting the method for producing the rabies vaccine, the purity of antigen of the purified stoste can be remarkably purified, and the purity can meet standards (greater than 95%) of a recombinant DNA (Deoxyribonucleic Acid) technique treatment biological products; the impurity residue amount is further reduced, particularly the residue of HCP (Hexachlorophene) can be reduced, and the limit standard is remarkably greater than those of similar products of the conventional national formulary; the immunogenicity of effective components is further improved, and on the premise of higher NIH (National Institutes of Health) titer,the content of stoste proteins of each dosage of the vaccine is remarkably lower than limits of similar products of the conventional national formulary.

Description

technical field [0001] The invention belongs to the technical field of vaccine biology, and in particular relates to a production method of a rabies vaccine. Background technique [0002] Rabies is a highly fatal disease. Due to the lack of effective treatment, once a person enters the disease stage after being exposed to the virus, death is almost inevitable. Vaccination is the only effective means of controlling the occurrence and prevalence of human rabies. The 130-year practice of R&D, production and use of rabies vaccines has proved that the quality of rabies vaccines for human use has been continuously improved through continuous innovation of production methods, which is of great help to improving the protective effect of vaccines, saving the lives of more exposed people and reducing the risk of vaccine users. The incidence of adverse reactions is of great significance. [0003] In the existing production methods of human rabies vaccines, the purification process m...

AI Technical Summary

Problems solved by technology

[0006] (2) Poor controllability of active ingredient dosage

Due to the high content of impurities, it is impossible to use fast and accurate physical and chemical analysis methods to detect and control the dosage of active ingredients, and can only rely on NIH potency test method or ELISA test method

The test results of the two methods are not accurate, and the former test result has a large deviation range (according to the data released by the World Health Organization Expert Committee, the NIH potency test result deviation range is 25% to 400%); The total amount of related impurities (viruses with abnormal structure and low immunogenicity) has poor correlation with biological potency

If the dose of the active ingredient cannot be accurately controlled, the low dose may lead to immune failure; or the high dose may lead to an increase in the incidence of adverse reactions

[0007] (3) The preparation is complex and poor in stability

Excessive excipients not only increase the metabolic burden of the user, but also increase the production cost of the product

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