Process for preparing veterinary rabies inactivated and freeze-dried vaccine through suspension culture cell

Abstract

The invention relates to a process for preparing a veterinary rabies inactivated vaccine, in particular to a process for preparing a veterinary rabies inactivated and freeze-dried vaccine through a suspension culture cell. The method has the key point that: a bioreactor is used for large-scale suspension culture of baby hamster kidney BHK21-C13 cells and rabies virus is inoculated, and the rabiesvirus is subjected to mass propagation through a fed-batch and perfusion technology, so that a high-concentration and high-titer rabies antigen is obtained and concentrated, inactivated and purified to prepare the veterinary rabies inactivated vaccine; and thus, technical problems such as complexity, low antigen content, low effectiveness, large dosage, poor batch-to-batch variation and the like existing in the conventional process are solved.

Description

technical field [0001] The invention relates to a method for manufacturing an inactivated rabies vaccine for veterinary use, in particular to a process for producing an inactivated rabies lyophilized vaccine for veterinary use by suspension culture cells. Background technique [0002] About 93% of Chinese rabies patients are caused by domestic dogs, 6% are caused by cats, and a few are caused by pigs and mice. Therefore, the localization of veterinary rabies inactivated vaccines and domestic animals are regularly injected with rabies inactivated vaccines It is an important way to control and eliminate rabies in our country. At present, the production of veterinary inactivated rabies vaccines in China uses the traditional rotary bottle process, which is cumbersome and has low antigen content, which cannot meet the quality requirements. At present, there is no supply in the market. All veterinary inactivated rabies vaccines are completely dependent on imports, which are expens...

AI Technical Summary

Problems solved by technology

At present, the production of veterinary inactivated rabies vaccines in China uses the traditional rotary bottle process, which is cumbersome and has low antigen content, which cannot meet the quality requirements. At present, there is no supply in the market. All veterinary inactivated rabies vaccines are completely dependent on imports, which are expensive and costly. , It is difficult to promote and use in rural areas and economically backward areas, which is not conducive to the prevention and control of animal rabies. Therefore, the development of safe and efficient veterinary rabies inactivated vaccines, the localization of veterinary rabies inactivated vaccines as soon as possible, and the reduction of vaccine costs can be controlled. and eradication of rabies

[0003] At present, the domestic BHK21-C13 cell production of veterinary rabies vaccine still uses the traditional spinner bottle culture process, which has small batches, low efficiency, high labor intensity, and takes up a lot of space. Rabies virus strains (Flury strains, etc.) are inoculated to grow in a single layer The BHK21-C13 cells were maintained for 4-5 days, harvested at one time, frozen and thawed, and prepared into a vaccine

Because each spinner bottle is an independent cell culture unit, the cell quality, virus yield and titer of each bottle are different, and the operation is labor-intensive, resulting in large batch-to-batch variation of domestic rabies vaccines and high endotoxin caused by hidden contamination and other shortcomings

[0004] Reactor suspension culture BHK21-C13 cells to produce rabies virus technology is a way to solve the above problems, but at present there is no mature method of using BHK21-C13 cell suspension technology to manufacture veterinary rabies inactivated vaccine, and the specific process conditions need to be optimized. To achieve the purpose of producing high-quality veterinary rabies inactivated vaccine

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