Study On Detoxification And To Take Off Poison Process Of Acellular Pertussis (Component) Vaccine

Pertussis is an acute infectious disease caused by Bordetella pertussis infection.Acellular pertussis vaccine is an effective method to control the spread of the pertussis bacteria.By purification process, the extraction of acellular pertussis vaccine is immunogenic antigen composition in bacteria, removing the toxic substances that have no immunogenicity and cause adverse reactions. These components with high immunogenicity include pertussis toxin(PT), filamentous hemagglutinin(FHA), pertactin(PRN).The three different antigens purified by column chromatography, the three effective components PT, FHA and PRN of them were detoxified with different agents and different detoxification meth, retainning their components immunogenic and removing their pathogenic toxicity, then remove harmful detoxification agent by an effective way,proportionate consolidation, tested qualified, Be the acellular pertussis(component) vaccine mentioned herein.Detoxification is the key steps of removing the pertussis toxin toxicity, and retaining their biological original. The study is of great significance to product the pertussis vaccine of high effect and safe pertussis vaccine. The effects of the removal poison after detoxification of components, affects the efficacy and safety of the pertussis(component)vaccine. To explore the detoxification conditions of PT purification liquid, FHA purification liquid and PRN purification liquid, the way to take off poison after detoxification of PT and FHA, PRN purification liquid conducts research, is the main content of this article.This study PT purified liquid, FHA purified liquid, and PRN purified liquid were detoxified respectively with different methods, testing toxicity effect of the way taking off the poison after different detoxification, and according to the proportion of combination of component detoxified by different detoxification method, pertussis(component) vaccine concentrate should be carried out after full inspection. According to the different test results,the detoxification method of three components are:PT purification liquid diluted by PBSand glycerol. And then detoxified with glutaraldehyde and aspartate. FHA purification liquid diluted with PBS. And then detoxified with glycine and formaldehyde. PRN purification liquid diluted with carbonate buffer. And then joining the glutaraldehyde, L-lysine for the detoxification.In this paper, the purified liquids after detoxication use two different methods : dialysis and ultrafiltration to take off poison. After testing, sterile results show that the ultrafiltration method can ensure that aseptic; Residual amount of poison, such as Glutaraldehyde and formaldehyde, is so little difference between. And for the sake of manpower and time cost,ultrafiltration is a better choice.According to the method above for detoxification, then taking off the poison by ultrafiltration, is feasible. The acellular pertussis(component) vaccine produced are qualified.