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Process for preparing human immunoglobulin for intravenous injection

A technology of human immunoglobulin and preparation process, which is applied in the field of biopharmaceuticals, can solve problems such as the influence of product purity, and the effect of coagulation factors is not obvious, and achieve the effects of improving product quality, improving product biological activity, and improving stability

Active Publication Date: 2012-07-18
华润博雅生物制药集团股份有限公司
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, this method is not very effective in removing coagulation factors, which affects the purity of the product to a certain extent.
The product yield can only reach about 6.3 grams per liter of plasma, and the purity can only reach more than 98%

Method used

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  • Process for preparing human immunoglobulin for intravenous injection
  • Process for preparing human immunoglobulin for intravenous injection
  • Process for preparing human immunoglobulin for intravenous injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] Embodiment 1: The preparation process is as follows:

[0043] (1) Centrifuge the qualified human plasma during the quarantine period. When centrifuging, the centrifugation speed should not exceed 4L / min / unit, and the temperature of the liquid should be controlled at 0-4°C; the cryoprecipitate should be separated, and the cryoprecipitate should be used for the production of factor VIII. Transfer the centrifuged supernatant protein solution to the protein separation reaction tank, so that the temperature of the protein solution is controlled between 1 and 3°C, and the pH of the protein solution is adjusted by adding pH 4.0 acetic acid buffer at a flow rate of no more than 1.0L / min to adjust the pH of the protein solution to 6.80~ 7.00; add -15°C or colder 95% ethanol, the flow rate does not exceed 1.5L / min, so that the final concentration of ethanol volume ratio reaches 8%, the temperature is controlled at -1 ~ -3°C, and the pH value is 6.80 after adding ethanol ~7.20; th...

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Abstract

The invention relates to a process for preparing human immunoglobulin for intravenous injection, and belongs to the field of biological pharmacy. The precipitate of components II and III in the process for preparing the human immunoglobulin for intravenous injection is treated by a caprylic acid and calcium chloride precipitation method, miscellaneous proteins are removed from the precipitate of the components II and III, and two-step chromatography is performed. Compared with the general caprylic acid precipitation method, the process has the advantages that various blood coagulation factors are effectively removed from a precipitate solution of the components II and III by adding calcium chloride, the stability of the immunoglobulin is improved, and the yield of the product is obviously improved, namely more than 7g of immunoglobulin can be prepared from each liter of blood plasma; upper column chromatographic purification is performed by two ion exchange columns and a chromatographic technology, so that the miscellaneous proteins can be effectively removed, and the purity of the product is over 99.5 percent; and in addition, caprylic acid is added, and viruses are removed and filtered by a DV20 filter element, so that a virus removing effect can be obviously improved, and the safety of clinical medication is improved.

Description

technical field [0001] The invention relates to a preparation process for intravenous injection of human immunoglobulin, which belongs to the field of biopharmaceuticals. Background technique [0002] The active ingredient of intravenous human immunoglobulin is protein, and more than 95% of it is immunoglobulin. It is made from healthy human plasma, which is separated and purified by low-temperature ethanol protein separation method or octanoic acid precipitation method, anti-complement activity is removed, and virus inactivation is processed. The usual production methods are low-temperature ethanol centrifugation (press filtration) method and caprylic acid precipitation method, and the product yield is low and the stability is not good. [0003] The existing low-temperature ethanol method for intravenous injection of human immunoglobulin uses low-temperature ethanol to treat the precipitation of component II+III. analysis process. In this method, during the process of se...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07K1/36C07K1/30C07K1/18
Inventor 梁小明邓志华何淑琴刘敏亮
Owner 华润博雅生物制药集团股份有限公司
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