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Method for rapidly screening vaccine finished products by using dynamic light scattering technology

A dynamic light scattering and vaccine technology, which is applied to the measurement of scattering characteristics, resistance to media-borne diseases, instruments, etc., can solve the problem that the effectiveness and stability of vaccines cannot be quickly screened, the test results of finished vaccines cannot be quantitatively compared, and cannot reflect Inter-batch differences and other issues, to achieve the effect of improving stability and product quality, good stability of test results, and short test cycle

Pending Publication Date: 2022-08-09
LIAONING CHENGDA BIOTECH
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  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, the potency and thermal stability of traditional inactivated virus vaccines generally use animal experiments. However, animal experiments have certain defects: First, due to the influence of different animal batches, the test results of finished vaccines cannot be quantified and compared, and cannot reflect the differences between batches. The second is that the detection cycle of animal experiments is long, and it is impossible to quickly screen the effectiveness and stability of the vaccine under the current dilution ratio, thus restricting the production rate of the vaccine

Method used

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  • Method for rapidly screening vaccine finished products by using dynamic light scattering technology
  • Method for rapidly screening vaccine finished products by using dynamic light scattering technology
  • Method for rapidly screening vaccine finished products by using dynamic light scattering technology

Examples

Experimental program
Comparison scheme
Effect test

preparation example 1-7

[0040] Preparation example 1-7 provides a kind of Japanese encephalitis inactivated virus vaccine, adopts the following method:

[0041] The difference between the above preparation examples is: in the preparation process of the JE inactivated virus vaccine, the dilution ratio of the JE inactivated virus vaccine stock solution is specifically shown in Table 1.

[0042] The preparation method of JE inactivated virus vaccine is as follows: firstly, weigh human albumin in proportion, dissolve it in PBS solution to obtain a diluent, and control the salt concentration in the diluent to be 0.145mM and pH to be 7-8; then Take 10 mg of the JE inactivated virus vaccine stock solution and mix it with the above dilution to obtain the JE inactivated virus vaccine. Among them, the concentration of human serum albumin in the JE inactivated virus vaccine is 2%.

[0043] Table 1 Dilution ratio of JE inactivated virus vaccine stock solution in Preparation Examples 1-7

[0044]

preparation example 8-10

[0046] Preparation example 8-10 provides a kind of Japanese encephalitis inactivated virus vaccine, adopts the following method:

[0047] The difference between the above preparation example and preparation example 3 is: in the preparation process of the JE inactivated virus vaccine, the concentration of human albumin is specifically shown in Table 2.

[0048]The concentration of human albumin in the JE inactivated virus vaccine provided in Table 2 Preparation Example 3 and Preparation Example 8-10

[0049]

[0050]

[0051] Test results

[0052] Detect the JE inactivated virus vaccine provided in Preparation Example 1-10, and measure its particle size and aggregation temperature T respectively. agg Value, potency and thermal stability, and compared the test results.

[0053] Particle size and aggregation temperature T agg Value (the onset temperature of protein aggregation) was measured using a WYATT DynaProPlate Reader III high-throughput protein solution stability ...

Embodiment 1

[0081] Example 1 provides a method for rapidly screening finished vaccine products using dynamic light scattering technology.

[0082] The above method includes the following steps:

[0083] (1) According to the test results of Preparation Examples 1-10, the accelerated thermal stability test and the long-term stability test, the particle size test results of the JE inactivated virus vaccine were correlated with the titer and thermal stability test results to establish a dynamic Light Scattering Database.

[0084] (2) Selecting the finished JE inactivated virus vaccine synthesized at different dilution ratios in the same batch, and using the WYATTDynaPro Plate Reader III high-throughput protein solution stability analyzer to detect the particle size of each JE inactivated virus vaccine product; using The dynamic light scattering database can quickly determine the titer and thermal stability of the JE inactivated virus vaccine under each particle size, and simultaneously detec...

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Abstract

The invention relates to the technical field of vaccine quality detection, and particularly discloses a method for rapidly screening vaccine finished products by using a dynamic light scattering technology. The method comprises the following steps: firstly, determining the relationship among the particle size, the titer and the thermal stability of the vaccine, and establishing a dynamic light scattering database; and comparing the particle size of the vaccine to be detected with the dynamic light scattering database to screen out the optimal vaccine synthesis dilution ratio. Rapid screening of vaccine finished products can be achieved, the quality and production rate of the vaccine finished products are improved, and the method has the advantages of being easy to operate, high in screening efficiency and the like.

Description

technical field [0001] The present application relates to the technical field of vaccine quality detection, in particular to a method for rapidly screening finished vaccine products using dynamic light scattering technology. Background technique [0002] The traditional inactivated virus vaccine is to inoculate the virus on suitable animal cells. After propagation, the virus is released into the culture solution. After clarification, ultrafiltration concentration, inactivation and purification, the inactivated virus vaccine stock solution is obtained. The live virus needs to be stored for a longer time, and a protective agent needs to be added. The inactivated virus vaccine stock solution and the protective agent are mixed to form an inactivated virus vaccine. Since the vaccine product is composed of inactivated virus vaccine stock solution and protective agent, in order to reduce side effects, the inactivated virus vaccine stock solution will be diluted during the vaccine s...

Claims

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Application Information

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IPC IPC(8): G01N21/47G01N15/00G01N15/02G01N33/569
CPCG01N21/47G01N15/00G01N15/0211G01N33/56983G01N2015/0038G01N2015/0222Y02A50/30
Inventor 刘俊曹鹏于海李沛阳杨兵康文哲于宏跃
Owner LIAONING CHENGDA BIOTECH
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