Preparing method for human lymphocyte immune globulin antibody raw material

An immunoglobulin and lymphocyte technology, which is applied in the field of preparation of anti-human lymphocyte immunoglobulin raw materials, can solve the problems of multiple side effects of finished heteroantibodies, difficulty in the source of raw materials, etc., so as to improve the product safety factor, reduce production costs, and improve the The effect of product quality

Inactive Publication Date: 2007-08-15
CHANGSHA BOKANG BIOLOGY MEDICAL RES INST
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The purpose of the present invention is to overcome the disadvantages of the existing preparation methods, such as the difficulty in raw material sources and the large nu

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0011] Example 1: Preparation method of pig anti-human lymphocyte immunoglobulin raw material

[0012] The cells involved in the embodiment of the present invention include Jurkat cell line and human thymic lymphocytes, wherein the Jurkat cell line is purchased from ATCC, and the human thymic lymphocyte line is obtained from stillborn infants induced in a hospital for more than 6 months. In the embodiment, if no special instructions, all are conventional methods.

[0013] The CD antigen molecules of the purchased Jurkat cell line were detected by flow cytometry, and the results showed that: CD2 + Express 99.64%, CD3 + Express 99.99%, CD4 + Expression 91.66%, CD8 + Express 0.14%. At the same time, the CD antigen molecules of human thymic lymphocytes were detected by flow cytometry, and the results showed that: CD2 + Express 99.91%, CD3 + Expression 76.87%, CD4 + Expression 91.53%, CD8 + Expressed 91.53%.

[0014] The Jurkat cell line was inoculated in culture flasks of...

Embodiment 2

[0020] Example 2: Preparation method of rabbit anti-human lymphocyte immunoglobulin raw material

[0021] Using Jurkat cells, rabbits were immunized according to the immunization procedure stipulated in "Pharmacopoeia III" to prepare rabbit anti-human lymphocyte immunoglobulin raw material serum, and to perform E rosette formation inhibition test and lymphocytotoxicity according to the rabbit anti-human T cell immunoglobulin test standard Test, human erythrocyte antibody determination, human platelet antibody determination.

[0022] The results of E rosette formation inhibition test and lymphocytotoxicity test show that the antibody level obtained by immunizing rabbits with Jurkat cell line is the same as that obtained by immunizing rabbits with thymus lymphocytes, and both reach the level of rabbit anti-human T cell immunoglobulin in "Pharmacopoeia III". The verification standard of protein, that is, neither of them is lower than 1:512. However, when rabbits were immunized w...

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Abstract

The invention discloses a making method of antihuman lymphocyte immunoglobulin, which is characterized by the following: adopting Jurkat cell system to replace human thymic lymphocyte as immunogen; reducing manufacturing cost without removing antibody step; fitting for large scale of manufacturing with high safe coefficient.

Description

technical field [0001] The invention belongs to the field of preparation methods of biological preparation raw materials, and in particular relates to a preparation method of anti-human lymphocyte immunoglobulin raw materials. Background technique [0002] Anti-lymphocyte immunoglobulin (ATG) is a kind of biological immunosuppressant, which can activate complement after combining with T lymphocytes of patients, inhibit or remove T lymphocytes in human body, and is mainly used clinically for rejection of tissue and organ transplantation And the treatment of malignant immune diseases such as acute aplastic anemia. [0003] At present, the domestic ATG preparation method is as follows: use human thymus lymphocytes as the immunogen, and obtain the raw material serum of anti-human lymphocyte immunoglobulin products after immunizing pigs or rabbits. Globulin preparations. The human thymus lymphocyte line used for the preparation of this product is taken from a dead baby who was ...

Claims

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Application Information

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IPC IPC(8): C07K16/18C07K16/24
Inventor 李宏实
Owner CHANGSHA BOKANG BIOLOGY MEDICAL RES INST
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