Method for purifying detoxified pertussis vaccine antigen solution

Abstract

The invention provides a method for purifying a detoxified pertussis vaccine antigen solution, which comprises the following steps of: preadjusting the conductivity and pH of the detoxified pertussis vaccine antigen solution; ultrafiltering the detoxified pertussis vaccine antigen solution by adopting a hollow fiber ultrafiltering system; carrying out washing filtration and leaching on the hollowfiber ultrafiltering system with washing filtration liquid; and mixing the filtered pertussis antigen solution with leaching liquid obtained by leaching to obtain a purified pertussis vaccine antigensolution. According to the method for purifying the detoxified pertussis vaccine antigen solution, the detoxified acellular pertussis antigen solution is purified by adopting a hollow fiber ultrafiltering method so as to remove a detoxifying agent and a pigment molecule generated in the detoxifying process. The pertussis vaccine antigen solution obtained by purifying through the method is detected, and the glutaraldehyde, lysine content and antigen solution appearance of the pertussis vaccine antigen solution reach the standard specified by Chinese pharmacopoeia 2010 III. The method has the characteristics of high working efficiency, high yield, high valence of products, adaption for industrialized production, capabilities of realizing full-closed operation and reducing pollution risk, and the like.

Description

technical field [0001] The invention belongs to the field of biotechnology, and relates to a method for purifying a detoxified pertussis vaccine antigen solution, in particular to a method for purifying a detoxified acellular pertussis antigen solution by using a hollow fiber ultrafiltration method. Background technique [0002] Whooping cough (pertussis, whooping cough) is a highly contagious respiratory disease caused by Gram-negative bacillus pertussis. Neonatal and infant patients can cause apnea and cyanosis. Pertussis is highly contagious and difficult to diagnose in the early stage of the disease, so vaccination is the most economical and effective way to prevent and control pertussis. Pertussis vaccines currently on the market mainly include whole-cell pertussis vaccine and acellular pertussis vaccine. It is widely used because it retains a good immune effect without adverse reactions. According to different methods of effective antigen purification, the productio...

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Problems solved by technology

[0004] Although tangential flow filtration has many advantages compared with traditional flow dialysis, but at present, this technology has not been applied to remove the detoxification agent in the detoxified pertussis antigen solution at home and abroad.

This is because both pertussis toxin (PT) and filamentous hemagglutinin (FHA), the main components of the acellular pertussis vaccine, have strong hydrophobic aggregation properties, and significant flocculent aggregation will occur after detoxification treatment, and after diafiltration During the process, as small molecular chaperones are gradually replaced by buffer, this flocculation will increase, and the materials selected for ultrafiltration often have complex fluid channels, which will cause a decrease in tangential flow velocity and accumulation of protein precipitates Blockage, resulting in a sharp drop in work efficiency and harvest rate, so it is not suitable for industrialization needs

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