Method for removing residual dna in human Japanese encephalitis vaccine products by using hollow fiber membrane

A Japanese encephalitis and fiber membrane technology is applied to the field of removing residual DNA in human Japanese encephalitis vaccine products by using hollow fiber membranes, which can solve problems such as adverse reactions and cancer occurrence, and achieve easy operation and management, low cost, The effect of simple process

Active Publication Date: 2016-12-21
LIAONING CHENGDA BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] The Japanese encephalitis vaccine for humans is to inoculate Japanese encephalitis virus on suitable animal cells, and release the virus into the culture medium after reproduction, during which some residual host cells or their fragments will also be mixed in the culture medium. After clarification, concentration, inactivation, and purification, the stock solution of Japanese encephalitis virus vaccine will produce free host DNA and host DNA combined with antigenic protein. The stock solution also contains a large amount of host protein. The concentration and purification process will A certain proportion of free DNA is removed, but there will still be residual DNA, especially the DNA combined with the virus or antigen protein will remain in the purified stock solution. If the removal is not complete, this part of the residual DNA will be discarded together with the finished vaccine. Injected into the human body, it may cause adverse reactions in the human body, or may cause cancer

Method used

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  • Method for removing residual dna in human Japanese encephalitis vaccine products by using hollow fiber membrane
  • Method for removing residual dna in human Japanese encephalitis vaccine products by using hollow fiber membrane
  • Method for removing residual dna in human Japanese encephalitis vaccine products by using hollow fiber membrane

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Select a batch of Japanese encephalitis vaccine virus harvest liquid, and use a sleeve filter to clarify and filter it. The type of the sleeve filter system is TP012TV25TCTFELB, the pore size is 0.65 μm, and the membrane area is about 4.0m 2 , the inlet pressure of the feed liquid is less than 10PSI, the outlet pressure of the feed liquid is about 0PSI, the total volume of the processed human Japanese encephalitis vaccine harvest liquid is 230L-240L, and the total working time is 1.5h-2.0h. The whole clarification and filtration process The temperature of the feed liquid is guaranteed to be between 18°C ​​and 26°C. The liquid obtained after filtration enters the concentration process, and is made into a concentrated liquid of Japanese encephalitis vaccine for human use through an ultrafiltration concentration system. The batch number after inactivation is SA- 01, and then purified by a molecular sieve chromatography system, the batch number of the purified Japanese encep...

Embodiment 2

[0025] Select a batch of human Japanese encephalitis vaccine virus harvest liquid, and use the hollow fiber membrane to micro-filter it. The model of the hollow fiber membrane system is CFP-6-D-8A, the pore size is 0.65 μm, and the membrane area is about 4.0m 2 , the pressure at the inlet end of the feed liquid is less than 10PSI, the pressure at the outlet end of the feed liquid is about 0PSI, and the pressure at the return end of the feed liquid is less than 3PSI. 1.5h-2.0h, the temperature of the feed liquid is guaranteed to be between 18°C ​​and 26°C during the entire microfiltration process. The liquid obtained after filtration enters the concentration process, and is made into Japanese encephalitis vaccine concentrate through an ultrafiltration concentration system. After inactivation, the batch number is SA-03, and then purified through a molecular sieve chromatography system. The collected human The batch number of Japanese encephalitis vaccine purified liquid is SA-0...

Embodiment 3

[0028] Select a batch of human Japanese encephalitis vaccine virus harvest liquid, and use the hollow fiber membrane to micro-filter it. The model of the hollow fiber membrane system is CFP-6-D-8A, the pore size is 0.65 μm, and the membrane area is about 4.0m 2 , the pressure at the inlet end of the feed liquid is less than 10PSI, the pressure at the outlet end of the feed liquid is about 0PSI, and the pressure at the return end of the feed liquid is less than 3PSI. 0.8h-1.0h, the temperature of the feed liquid is guaranteed to be between 18°C ​​and 26°C throughout the microfiltration process. The liquid obtained after filtration enters the concentration process, and is made into Japanese encephalitis vaccine concentrate through an ultrafiltration concentration system. After inactivation, the batch number is SA-05, and then purified through a molecular sieve chromatography system. The collected human The batch number of the Japanese encephalitis vaccine purified liquid is SA-...

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Abstract

The invention relates to a method for removing residual DNA in an encephalitis B vaccine product for human by utilizing a hollow fiber membrane. The method is characterized in that an encephalitis B vaccine obtaining liquid for human is used as a raw material, other proteins and DNA in the encephalitis B vaccine obtaining liquid for human are removed through a hollow fiber membrane microfiltration process, the obtained filtered liquid is collected and is processed by an ultrafilration concentration system to prepare an encephalitis B vaccine concentrate for human, the concentrate is inactivated, and the obtained inactivated encephalitis B vaccine liquid for human is purified by using a molecular sieve chromatography purifying system. A certain proportion of DNA residual in the product is effectively removed through the microfiltration treatment of the virus obtaining liquid by the hollow fiber membrane without influencing the biological activity of the vaccine product, so the residual quantity of DNA in the finished vaccine product reaches a qualified standard.

Description

technical field [0001] The invention relates to a method for removing DNA and miscellaneous proteins in Japanese encephalitis vaccine products for human use, in particular to a method for removing residual DNA in Japanese encephalitis vaccine products for human use by using a hollow fiber membrane. The hollow fiber membrane mentioned in the present invention is a hollow fiber microfiltration membrane, and its main material is PP or PVDF. Background technique [0002] The Japanese encephalitis vaccine for humans is to inoculate Japanese encephalitis virus on suitable animal cells, and release the virus into the culture medium after reproduction, during which some residual host cells or their fragments will also be mixed in the culture medium. After clarification, concentration, inactivation, and purification, the stock solution of Japanese encephalitis virus vaccine will produce free host DNA and host DNA combined with antigenic protein. The stock solution also contains a lar...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K39/12
CPCY02A50/30
Inventor 高军白珠穆李旭李庆岸秦大伟石雅丽
Owner LIAONING CHENGDA BIOTECH
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