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Respiratory syncytial virus resistance human immune globulin and preparation method thereof

A technology of human immunoglobulin and immunoglobulin, which is applied in the direction of antiviral immunoglobulin, immunoglobulin, peptide preparation methods, etc., can solve the problems of unstable properties and low efficiency of human immunoglobulin, and achieve long shelf life , large social and economic benefits, good specificity

Active Publication Date: 2016-05-25
哈尔滨派斯菲科生物制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] However, due to the strict requirements for the selection of raw materials and preparation conditions in the preparation of human immunoglobulins, the current human immunoglobulins generally have problems such as low efficiency and unstable properties.

Method used

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  • Respiratory syncytial virus resistance human immune globulin and preparation method thereof
  • Respiratory syncytial virus resistance human immune globulin and preparation method thereof
  • Respiratory syncytial virus resistance human immune globulin and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0054] 1. Screening and collection of plasma from donors:

[0055] Select the plasma, and use the neutralization test method to detect the neutralization titer of the respiratory syncytial virus antibody in the raw plasma should meet the following conditions: the neutralization titer is not less than 1:200; the protein content (detected by the biuret method) is greater than or equal to 56g / L; alanine aminotransferase (monitored by Lai's method) was not higher than 35 units; ELISA method was negative for syphilis, hepatitis B surface antigen, HIV-1 / HIV-2 antibody, and HCV antibody. Store in a freezer below -20°C, and the shelf life should not exceed 2 years.

[0056] 2. Determination of antibody titer in raw plasma by neutralization test:

[0057] (A) MEM cell culture medium (purchased from Gibco) of the plasma sample to be tested was pre-diluted 1:4 with cell maintenance medium (3% fetal bovine serum by volume, purchased from Gibco), and then inactivated at 56°C for 30 Minut...

Embodiment 2

[0087] 1. Screening and collection of plasma from donors:

[0088] Select the plasma, and use the neutralization test method to detect the neutralization titer of the respiratory syncytial virus antibody in the raw plasma should meet the following conditions: the neutralization titer is not less than 1:200; the protein content (detected by the biuret method) is greater than or equal to 56g / L; alanine aminotransferase (monitored by Lai's method) was not higher than 35 units; ELISA method was negative for syphilis, hepatitis B surface antigen, HIV-1 / HIV-2 antibody, and HCV antibody. Store in a freezer below -20°C, and the shelf life should not exceed 2 years.

[0089] 2. Determination of antibody titer in raw plasma by neutralization test:

[0090] (A) MEM cell culture medium (purchased from Gibco) of the plasma sample to be tested was pre-diluted 1:4 with cell maintenance medium (3% fetal bovine serum by volume, purchased from Gibco), and then inactivated at 56°C for 30 Minut...

Embodiment 3

[0112] 1. Screening and collection of plasma from donors:

[0113] Select the plasma, and use the neutralization test method to detect the neutralization titer of the respiratory syncytial virus antibody in the raw plasma should meet the following conditions: the neutralization titer is not less than 1:200; the protein content (detected by the biuret method) is greater than or equal to 56g / L; alanine aminotransferase (monitored by Lai's method) was not higher than 35 units; ELISA method was negative for syphilis, hepatitis B surface antigen, HIV-1 / HIV-2 antibody, and HCV antibody. Store in a freezer below -20°C, and the shelf life should not exceed 2 years.

[0114] 2. Determination of antibody titer in raw plasma by neutralization test:

[0115] (A) MEM cell culture medium (purchased from Gibco) of the plasma sample to be tested was pre-diluted 1:4 with cell maintenance medium (3% fetal bovine serum by volume, purchased from Gibco), and then inactivated at 56°C for 30 Minut...

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Abstract

The invention relates to respiratory syncytial virus resistance human immune globulin and a preparation method thereof. The titer of the respiratory syncytial virus neutralizing antibody is larger than or equal to 1:900. The preparation method includes the steps of firstly, screening out privilege plasma with titer of the respiratory syncytial virus neutralizing antibody not lower than 1:200; secondly, mixing screened-out efficient privilege plasma; thirdly, separating the mixed plasma through a low-temperature ethyl alcohol filter press method, purifying and separating out a immune globulin component II through the combination with the ion-exchange column chromatography method, and obtaining immune globulin with the purity of 98-100% through filtration, chromatography, ultrafiltration, preparation, low-pH incubation virus inactivation, nano-membrane filtration virus removal and subpackaging. The titer, purity and recycling rate of the respiratory syncytial virus resistance human immune globulin obtained through the preparation and production method are high, treatment can be conducted for the respiratory syncytial virus, and the respiratory syncytial virus resistance human immune globulin and the preparation method have advantages of being safe, effective and the like.

Description

technical field [0001] The invention relates to therapeutic blood products in the field of biopharmaceuticals, in particular to a respiratory syncytial virus human immunoglobulin and a preparation method thereof. Background technique [0002] Respiratory syncytial virus (RSV) belongs to the Pneumovirus genus of the Paramyxoviridae family. Virus particles are irregular spherical or filamentous with rough surfaces, with a diameter of about 300-500mn. There is an envelope composed of lipoproteins on the surface. There are helical nucleocapsids with a diameter of 13.5nm and a pitch of 6.5nm. RSV is one of the main pathogens of bronchiolitis and viral pneumonia in infants under 2 years old, and can induce or aggravate asthma. It is more common in winter and spring in northern my country, and more common in summer and autumn in the south. It is often associated with a sudden drop in temperature. Once the temperature rises, the incidence rate will drop. The annual epidemic season...

Claims

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Application Information

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IPC IPC(8): C07K16/10C07K1/36C07K1/34C07K1/18
CPCC07K16/1027C07K2317/10C07K2317/90
Inventor 孙婷杨金平李常禄于引航陈东明杨莉孙晓东闫磊
Owner 哈尔滨派斯菲科生物制药有限公司
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