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Method for preparing human immunoglobulin

A technology of human immunoglobulin and exchange chromatography, applied in the field of preparation of blood products, can solve the problems of high cost, difficult to realize large-scale industrial production, large volume of chromatography column, etc., and achieves low volume, good market application prospect, The effect of reducing production costs

Active Publication Date: 2012-07-04
CHENGDU RONGSHENG PHARMA
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AI Technical Summary

Problems solved by technology

[0006] However, compared with foreign countries, the IgM content in Chinese plasma is higher (the IgM content in Chinese plasma accounts for about 10% of the total protein content, and the IgM content in foreign plasma accounts for 1%-3% of the total protein content), according to The aforementioned method prepares immunoglobulins with qualified purity, and the chromatographic column required for the adsorption of a large amount of IgM by the chromatographic column is large in volume and high in cost, making it difficult to realize large-scale industrial production

Method used

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  • Method for preparing human immunoglobulin
  • Method for preparing human immunoglobulin

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Embodiment 1 prepares human immunoglobulin by the method of the present invention

[0028] 1. Experimental materials

[0029] Cohn fraction I+II+III or fraction II+III: prepared according to the low-temperature ethanol precipitation method described in "Medical Biological Products" (People's Health Publishing House), second edition, page 1194.

[0030] Hydrochloric acid, caprylic acid, Capto Q filler, Gigacap Q filler, Unosphere Q filler, Macrocap Q, diatomaceous earth and Beckman IMMAGE IgA detection kit are all commercially available.

[0031] 2. Experimental method

[0032] Such as figure 1 Prepare human immunoglobulins as indicated:

[0033] (1) Cohn Component I+II+III: Take 4kg Cohn Component I+II+III precipitate and dissolve it in 40L 5℃ WFI (Water for Injection), stir for 1h, use 0.5M hydrochloric acid to adjust the pH to 4.20, 25℃ water bath Heat and stir for 2h;

[0034] (2) Octanoic acid precipitation: directly add octanoic acid to a final concentration o...

Embodiment 2

[0049] Embodiment 2 parameter optimization experiment

[0050] Conductivity and pH value in the method step (4) of the present invention precipitate IgM and screen:

[0051] (1) Conductivity optimization experiment

[0052] Experimental method: other conditions are constant, change the conductivity and pH in step (4) of Example 1, and detect the relationship between conductivity and IgM precipitation and IgG yield.

[0053] Experimental results: It has been observed through multiple experiments that when the conductivity of the chromatography flow-through solution is higher than 1ms / cm, IgM will not precipitate even if the pH of the solution is increased. When the conductivity of the chromatographic flow-through solution is between 500 and 1000 us / cm, adjust the pH to above 6.0, and IgM will be obviously precipitated.

[0054] (2) pH optimization experiment

[0055] Experimental method: other conditions are constant, change the pH in step (4) of Example 1, and detect the rela...

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Abstract

The invention provides a method for preparing human immunoglobulin. The method comprises the following steps of: dissolving Cohn components I, II and III and Cohn components II and III, precipitating by using octanoic acid, performing anion-exchange chromatography for the first time, precipitating IgM, performing anion-exchange chromatography for the second time, performing ultrafiltration or dialyzing, preparing, inactivating virus and the like to obtain the high-purity human immunoglobulin. The invention also provides the human immunoglobulin prepared by the method and a medicinal composition. The method for preparing the human immunoglobulin is simple, and low in cost and has good industrial application prospect.

Description

technical field [0001] The invention relates to a method for preparing blood products, in particular to a method for preparing human immunoglobulin. Background technique [0002] Immunoglobulins include at least five types: IgG, IgM, IgA, IgE, and IgD. Among them, IgG is the most important immunoglobulin, and its deficiency will lead to low body defense. There are three main types of immunoglobulin preparations: intramuscular injection of human immunoglobulin, specific immunoglobulin and intravenous immunoglobulin. Currently, immunoglobulin preparations are mainly isolated from plasma. [0003] In the 1940s, Professor E.J. Cohn of Harvard University invented the process of separating plasma proteins by low-temperature ethanol. Later, Nistchmann and Kistler et al. improved on the basis of Cohn’s low-temperature ethanol method and proposed an improved method for separating plasma proteins by low-temperature ethanol. , Simplify the steps and shorten the production cycle. How...

Claims

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Application Information

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IPC IPC(8): C07K16/06C07K1/36C07K1/30C07K1/18A61K39/395
CPCA61K39/395C07K16/06C07K1/36C07K16/065C07K1/18
Inventor 杨汇川吕家成梁洪王焰武鹏李泽林兰学渊
Owner CHENGDU RONGSHENG PHARMA
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