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Chromatographic process for removing IgA and IgM in specific human immunoglobulin

A human immunoglobulin, specific technology, applied in the field of bioengineering, can solve the problems of reducing the recovery rate of IgG, etc., and achieve the effects of easy scale-up production, simplified process, and good purification effect

Pending Publication Date: 2020-06-05
HUALAN BIOLOGICAL ENG CHONGQING
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, there are no special steps for removing IgA and IgM in the existing processes of hepatitis B human immunoglobulin and rabies patient immunoglobulin, and only part of IgA and IgM can be removed during ethanol precipitation. If the existing production parameters are changed, it can improve The removal rate of IgA and IgM, but it will reduce the recovery rate of IgG

Method used

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  • Chromatographic process for removing IgA and IgM in specific human immunoglobulin
  • Chromatographic process for removing IgA and IgM in specific human immunoglobulin
  • Chromatographic process for removing IgA and IgM in specific human immunoglobulin

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Embodiment Construction

[0024] The present invention will be further described below with reference to specific embodiments. It should be understood that these examples are only used to illustrate the present invention and not to limit the scope of the present invention. The experimental methods that do not specify specific conditions in the following examples are generally in accordance with conventional conditions. Unless otherwise defined, all professional and scientific terms used herein have the same meanings as those familiar to those skilled in the art. In addition, any methods and materials similar or equivalent to those described can be used in the methods of the present invention. Methods and materials for preferred embodiments described herein are provided for illustrative purposes only.

[0025] A chromatographic process for removing IgA and IgM in specific human immunoglobulins, comprising the following steps:

[0026] S1-chromatographic solution preparation: prepare 0.5mol / L sodium h...

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Abstract

The invention discloses a chromatographic process for removing IgA and IgM in specific human immunoglobulin. The chromatographic process comprises the following steps: S1, secondary precipitate dissolution and filtration; S2, adjustment of parameters before chromatography; and S3, chromatography. According to the invention, a product with obvious IgA and IgM removal effects is obtained through chromatography by using a secondary precipitate component of a secondary precipitate after inactivation as an initial raw material; by adoption of a conductivity of 0.2-1.90 ms / cm, and after dissolutionof a precipitate, the conductivity is the same as the conductivity required by chromatography, and the conductivity is not independently adjusted any more, so the process is simplified, and scale-up production is easy; the process provided by the invention is improved on the basis of an original production process, so production is facilitated; and the chromatographic process has good purificationeffect and can achieve removal efficiency of 95% or above.

Description

technical field [0001] The invention relates to the technical field of bioengineering, in particular to a chromatographic process for removing IgA and IgM in specific human immunoglobulins. Background technique [0002] Specific human immunoglobulin is an immunoglobulin preparation prepared with high titer specific antibody plasma as raw material. The plasma containing specific antibodies is obtained by apheresis plasma technology, which is prepared by low-temperature ethanol separation method and inactivated by virus, and finally specific human immunoglobulins are obtained. [0003] Specific human immunoglobulins include hepatitis B human immunoglobulin, rabies patient immunoglobulin, tetanus human immunoglobulin and the like. Specific human immunoglobulins are mainly rich in monomeric and dimerized IgG, but also contain trace amounts of other globulins such as IgA, IgM, etc. Products containing these trace globulins will produce adverse reactions when used, such as clinic...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07K16/00C07K1/18
CPCC07K16/00C07K1/18
Inventor 张海梦肖岚滕世超张宝献张洛陈世洁
Owner HUALAN BIOLOGICAL ENG CHONGQING
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