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Purification method of human immunoglobulin for intravenous injection

A technology of human immunoglobulin and purification method, which is applied in the field of biopharmaceuticals, can solve problems such as side effects and allergic reactions, and achieve the effects of increasing sample loading, reducing production time limit, and easy to scale up production operations

Inactive Publication Date: 2018-10-09
HUALAN BIOLOGICAL ENG CHONGQING +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, there are mainly five types of immunoglobulins in human blood, each of which also includes multiple subspecies, among which IgA can cause anti-IgA in patients with congenital deficiency of IgA after infusion of intravenous human immunoglobulin, which may cause allergic reactions , produce side effects and become an unsafe factor

Method used

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  • Purification method of human immunoglobulin for intravenous injection
  • Purification method of human immunoglobulin for intravenous injection
  • Purification method of human immunoglobulin for intravenous injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment

[0050] 1. Test materials and instruments: strong anion exchanger, ultraviolet spectrophotometer, pH meter.

[0051] 2. Kits for the detection of IgA and IgM protein content: immunoglobulin A enzyme-linked immunosorbent assay kit; immunoglobulin M enzyme-linked immunosorbent assay kit.

[0052] 3. Detection of total protein content: biuret method

[0053] 4、试验材料:乙醇沉淀法制得的二次沉淀组分:01~18批,批号分别为M201709093、M201709093、M201709094、M201708087、M201708092、M201709095、M201709094、M201709094、M201709095、M201707066、M201707070、M201707071、M201709093、 M201709093, M201707078, M201710096, M201710098, M201710099.

[0054] Note: The batch numbers of batches 01 and 02 are the same batch number, and the batch numbers of batches 13 and 14 are the same batch number. This is because the production volume of one batch is large in the previous low-temperature ethanol production process, which can be divided into multiple times for chromatography.

[0055] 5. Required reagents:

[0056] 0.5mol / L sodium hydro...

Embodiment 1

[0064] 1. Test object: Batch No. 01 is M201709093

[0065] 2. Test process:

[0066] S1 Dissolution: Take water for injection at 6°C which is equivalent to 8 times the volume of the secondary precipitation component of batch 01, and test the endotoxin in the water for injection. After the endotoxin is qualified, it is used to dissolve the secondary precipitation component of batch 01, and stir to dissolve. The speed of the stirrer is controlled so that there is no foaming, and the stirring is stopped after 3 hours to obtain a solution, which is then sampled for the first time, and the protein concentration, pH, and conductivity are detected.

[0067] S2 Filtration: Install filter elements with 0.45μm pore size and 0.2μm pore size in sequence in the series filter stack, and rinse the filter until it is qualified. Filter the solution, control the filtration pressure to 0.13MPa, collect the filtered solution, and wash the filter with water for injection at 4.0°C after completion...

Embodiment 2

[0073] 1. Test object: Batch 02, batch number M201709093

[0074] 2. Test process:

[0075] S1 Dissolution: Take water for injection at 6°C equivalent to 5 times the volume of the secondary precipitation component of batch 02, and test the endotoxin in the water for injection. After the endotoxin is qualified, it is used to dissolve the secondary precipitation component of batch 02, and stir to dissolve. The speed of the stirrer is controlled so that no foaming prevails, and the stirring is stopped after 2 hours to obtain a solution, which is then sampled for the first time, and the protein concentration, pH, and conductivity are detected.

[0076] S2 Filtration: Install filter elements with 0.45μm pore size and 0.2μm pore size in sequence in the series filter stack, and rinse the filter until it is qualified. Filter batch 02 of the solution, control the filtration pressure to 0.14MPa, collect the filtered solution, and wash the filter with 8.0°C water for injection to obtain...

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Abstract

The invention discloses a purification method of human immunoglobulin for intravenous injection. The purification method is used for purification of a secondary sedimentation ingredient. The purification method of the human immunoglobulin for the intravenous injection is characterized by comprising the following steps of: S1, dissolve: dissolving the secondary sedimentation ingredient with water for injection, and stirring for 2-4h at 2.0-8.0 DEG C to form a dissolve liquid, S2, filtration: filtering the dissolve liquid with a 0.45 micrometers filter membrane and then with a 0.2 micrometers filter membrane to form a filtrate, S3: filtrate adjustment: adjusting a pH (potential of hydrogen) of the filtrate to 5.60-6.00, a protein concentration to 10-13g / L, and conductivity to 0.2-1.90ms / cm to form a pre-chromatography liquid, S4, chromatography: performing chromatography with strong anion exchange gel, flushing the gel before the chromatography for balancing to allow a difference betweena pH of the gel and a pH of the liquid before the chromatography to be from -0.10 to 0.10, performing gel chromatography sample loading at a linear flow rate of 0.5-1.5cm / min and chromatography loading capacity of not exceeding 600g / L, and collecting a liquid after the chromatography. The method is simple and controllable, and greatly reduces a content of IgA (immunoglobulin A) and IgM (immunoglobulin M) in the human immunoglobulin for the intravenous injection.

Description

technical field [0001] The invention relates to the field of biopharmaceuticals, in particular to a purification method for intravenous injection of human immunoglobulin. Background technique [0002] The active ingredient of intravenous injection of human immunoglobulin is human immunoglobulin, and the plasma of more than 1000 healthy people is used as raw material to obtain IgG immunoglobulin by separation. Intravenous injection of human immunoglobulin contains broad-spectrum IgG antibodies against viruses, bacteria or other pathogens. In addition, the idiotype and idiotype antibodies of immunoglobulins can form a complex immune network, so it has dual therapeutic effects of immune substitution and immune regulation. Clinically, it is mainly used for primary immunoglobulin deficiency, secondary immunoglobulin deficiency, and autoimmune diseases. [0003] The technology for extracting human immunoglobulins is mainly the low-temperature ethanol method, which began in the 19...

Claims

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Application Information

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IPC IPC(8): C07K16/00C07K1/36C07K1/34C07K1/18
CPCC07K16/00
Inventor 刘余江滕世超杨柳周康森张宝献李长明
Owner HUALAN BIOLOGICAL ENG CHONGQING
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