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A kind of intravenous giant cell human immunoglobulin and its preparation method

A human immunoglobulin and giant cell technology, applied in the field of biopharmaceuticals, can solve problems such as low efficiency and unstable properties, and achieve the effect of improving survival rate and high specificity

Active Publication Date: 2019-04-19
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, because giant cell human immunoglobulin has strict requirements on raw material selection and preparation conditions, the current giant cell human immunoglobulin generally has problems such as low efficiency and unstable properties.

Method used

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  • A kind of intravenous giant cell human immunoglobulin and its preparation method
  • A kind of intravenous giant cell human immunoglobulin and its preparation method
  • A kind of intravenous giant cell human immunoglobulin and its preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0050] 1. Screening and collection of plasma from donors:

[0051] Select the plasma, and use the neutralization test method to detect the neutralizing titer of the giant cell antibody in the raw plasma should meet the following conditions: the neutralizing titer is not less than 1:20; L; Alanine aminotransferase (monitored by Lai's method) is not higher than 35 units; ELISA method to determine syphilis, hepatitis B surface antigen, HIV-1 / HIV-2 antibody, HCV antibody are all negative. Store in a freezer below -20°C, and the shelf life should not exceed 2 years.

[0052] 2. Determination of antibody titer in raw plasma by neutralization test:

[0053] (A) After the plasma sample is pre-diluted 1:4 with the MEM cell culture medium of the cell maintenance solution, it is inactivated at 56°C for 30 minutes, and then continues to be diluted 5 times, that is, the final 1:20 times dilution; The cell maintenance medium was 5% fetal bovine serum by volume, and both the cell maintenan...

Embodiment 2

[0084] 1. Screening and collection of plasma from donors:

[0085] Select the plasma, and use the neutralization test method to detect the neutralizing titer of the giant cell antibody in the raw plasma should meet the following conditions: the neutralizing titer is not less than 1:20; L; Alanine aminotransferase (monitored by Lai's method) is not higher than 35 units; ELISA method to determine syphilis, hepatitis B surface antigen, HIV-1 / HIV-2 antibody, HCV antibody are all negative. Store in a freezer below -20°C, and the shelf life should not exceed 2 years.

[0086] 2. Determination of antibody titer in raw plasma by neutralization test:

[0087] (A) MEM cell culture medium (purchased from Gibco) of the plasma sample to be tested was pre-diluted 1:4 with cell maintenance medium (fetal bovine serum with a volume percentage of 5%, purchased from Gibco), and then extinguished at 56°C. Live for 30 minutes, then continue to 5-fold dilution, that is, the final 1:20-fold diluti...

Embodiment 3

[0110] 1. Screening and collection of plasma from donors:

[0111] Select the plasma, and use the neutralization test method to detect the neutralizing titer of the giant cell antibody in the raw plasma should meet the following conditions: the neutralizing titer is not less than 1:20; L; Alanine aminotransferase (monitored by Lai's method) is not higher than 35 units; ELISA method to determine syphilis, hepatitis B surface antigen, HIV-1 / HIV-2 antibody, HCV antibody are all negative. Store in a freezer below -20°C, and the shelf life should not exceed 2 years.

[0112] 2. Determination of antibody titer in raw plasma by neutralization test:

[0113] (A) MEM cell culture medium (purchased from Gibco) of the plasma sample to be tested was pre-diluted 1:4 with cell maintenance medium (5% fetal bovine serum by volume, purchased from Gibco), and then inactivated at 56°C for 30 Minutes, and then continue to 5-fold dilution, that is, the final 1:20-fold dilution.

[0114] (B) Tak...

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Abstract

The invention relates to intravenously injected cytomegalovirus human immune globulin and a preparation method thereof, and the titer of a cytomegalovirus neutralizing antibody of the human immune globulin is larger than or equal to 1:500. The preparation method comprises the steps that 1, positive plasma with the titer of the cytomegalovirus neutralizing antibody larger than or equal to 1:20 is screened out; 2, the screened-out efficient positive plasma is mixed; 3, the mixed plasma is separated through a low-temperature ethanol filter-pressing method, an immune globulin component II is separated and purified by combining an ion-exchange column chromatography method, viruses are removed through filtration, chromatography, ultrafiltration, preparation, low-pH incubation virus inactivation and nanofilm filtration, the immune globulin with the purity of 98.5%-100% is obtained through subpackaging, and the antibody titer is not lower than 1:500. The cytomegalovirus human immune globulin prepared through the preparation and production method is high in antibody titer, purity and recovery rate and capable of conducting targeted treatment on cytomegalovirus, is an effectively drug for treating recessive and dominant infection caused by the cytomegalovirus in people, is safe and reliable and has larger social benefits and economic benefits.

Description

technical field [0001] The invention relates to therapeutic blood products in the field of biopharmaceuticals, in particular to a giant cell human immunoglobulin and a preparation method thereof. Background technique [0002] Human cytomegalovirus (HCMV), also known as human herpesvirus type 5 (HHV5), belongs to the betaherpesvirus subfamily. HCMV is one of the most common pathogens of human congenital virus infection, and the infection rate of this virus in adults in my country is as high as 95%. Ordinary people are usually recessive infection, but for immunocompromised populations, such as bone marrow and solid organ transplant recipients, HIV-infected patients and tumor patients, HCMV infection can lead to serious consequences. Primary or recurrent HCMV infection in pregnant women can cause neonatal intrauterine infection or perinatal infection to invade the fetus, which can cause central nervous system involvement, multiple organ damage, mental retardation or deafness i...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07K16/08C07K1/36C07K1/34C07K1/18
CPCC07K16/088C07K2317/10C07K2317/90
Inventor 杨莉于引航孙晓东闫磊孙婷
Owner 哈尔滨派斯菲科生物制药有限公司
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