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vaccine protector

A technology of vaccine protective agent and protective agent, which is applied in antiviral agents, antibody medical components, viruses/bacteriophages, etc. It can solve the problems of high cost of trehalose and increased vaccine costs, and achieve the effect of simple components

Active Publication Date: 2021-08-03
成都柏奥特克生物科技股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] But trehalose is costly and requires a higher concentration to work, thus increasing the cost of vaccine production

Method used

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Embodiment 1 Serum-free human rabies vaccine protective agent of the present invention

[0028] The formula of the vaccine protection agent is: 2.5 parts by weight of sucrose, 2.5 parts by weight of maltose, 0.3 parts by weight of urea, and 3 parts by weight of human albumin.

[0029] When in use, the vaccine protective agent is dissolved in a phosphate buffer solution with a NaCl content of 0.2% to 0.9% (m / v), and the purified inactivated virus solution is added to make the final concentration of sucrose in the mixture 2.5% (m / v). v), the final concentration of maltose is 2.5% (m / v), the final concentration of urea is 0.3% (m / v), and the final concentration of human serum albumin is 3% (m / v).

Embodiment 2

[0030] Embodiment 2 Serum-free human rabies vaccine protective agent of the present invention

[0031] The formula of the vaccine protection agent is: 5 parts by weight of sucrose, 5 parts by weight of maltose, 0.5 part by weight of urea, and 1 part by weight of human albumin, which are dissolved in phosphate buffer saline with a NaCl content of 0.2% (m / v).

[0032] When in use, the vaccine protective agent is dissolved in a phosphate buffer solution with a NaCl content of 0.2% to 0.9% (m / v), and the purified inactivated virus solution is added to make the final concentration of sucrose in the mixture 5% (m / v). v), the final concentration of maltose is 5% (m / v), the final concentration of urea is 0.5% (m / v), and the final concentration of human serum albumin is 1% (m / v).

[0033] The present invention will be further described in the form of experimental examples below.

experiment example 1

[0034] Effect comparison of experimental example 1 rabies vaccine protective agent

[0035] 1. Preparation of inactivated virus solution

[0036] 1. Production cells

[0037] The cells used for production are Vero cells cultured without serum (serum-free Vero cells for short), which are imported from ATCC in the United States.

[0038] 2. Poison species

[0039] The virus used for production is the fixed rabies virus rPV-2061 strain, which was introduced from the CDC of the United States.

[0040] 3. Stock solution preparation

[0041] (1) Cell culture: Serum-free Vero cells were cultured at 37°C after recovery, and were continuously passaged and expanded at a split ratio of 1:3. After expansion, the cells were made into cell suspension, according to 6×10 5 The density of cells / ml was inoculated into a fixed-bed bioreactor (referred to as "bioreactor", the same below), and serum-free culture medium was used for perfusion culture. Culture parameters: temperature=37.0° C.,...

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Abstract

The invention discloses a vaccine protection agent, which belongs to the field of biological products. The protective agent is composed of the following components: 2.5-5 parts by weight of sucrose, 2.5-5 parts by weight of maltose, 0.3-0.5 parts by weight of urea, and 1-3 parts by weight of human albumin. The protective agent can effectively improve the thermal stability of the vaccine, reduce the loss of freeze-drying activity, and does not add trehalose, thereby reducing the cost.

Description

technical field [0001] The invention belongs to the field of biological products. Background technique [0002] Inactivated virus vaccine is the main type of rabies vaccine at present, and its production mainly includes: cultivating and expanding rabies virus in vitro, inactivating virus, purifying virus, adding vaccine protective agent, freeze-drying and other steps. [0003] The vaccine protective agent plays an indispensable protective role in the activity of the vaccine during the storage of the virus liquid before freeze-drying, during the freeze-drying process, and during the storage stage after freeze-drying. [0004] Li Chunyan et al. determined the optimal freeze-drying protective agent formula to be 4% trehalose, 3% dextran 40, 1% sucrose, and 0.5% mannose by changing the contents of the main components of the three protective agents, including trehalose, dextran 40, and human serum albumin. Alcohol and 2% human serum albumin can reduce the potency of semi-finishe...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K47/42A61K47/26A61K47/36A61K47/22A61K39/205A61P31/14
CPCA61K39/12A61K47/22A61K47/26A61K47/36A61K47/42A61K2039/5252A61P31/14C12N2760/20134
Inventor 梁智杰黄林崔利凯陈坤黄磊
Owner 成都柏奥特克生物科技股份有限公司