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Method for producing intravenous injection human immune globulin

A human immunoglobulin, intravenous injection technology, applied in the field of preparation of human plasma protein, can solve the problems of slow separation speed, difficult operating temperature, low product purity, etc., achieve high recovery rate, high production safety, and fast separation speed Effect

Active Publication Date: 2011-09-14
哈尔滨派斯菲科生物制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The operating temperature is not easy to control, the separation effect of the centrifuge is unstable, and the separation speed is slow. At the same time, the centrifuge is a high-speed operation equipment. Production safety accidents occur from time to time, and the production safety is not high; generally there is no further purification process step, and the product purity is not high.
For example, the patent application number is 02103826.0. That is to say, the centrifuge is used for separation, the operating temperature is not easy to control, the separation effect of the centrifuge is unstable, and the separation speed is slow. At the same time, the centrifuge is a high-speed operation equipment, and production safety accidents occur from time to time, and the production safety is not high.

Method used

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  • Method for producing intravenous injection human immune globulin
  • Method for producing intravenous injection human immune globulin
  • Method for producing intravenous injection human immune globulin

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0013] A. Separation of component I+II+III precipitation from plasma: 1000L of frozen plasma was thawed at 35°C, the plasma temperature was adjusted to 1°C, and the pH value of plasma was adjusted to 5.8 with acetate buffer with pH value of 4.0 , add 95% ethanol to make the final ethanol concentration in the plasma 20%, adjust the temperature of the reaction solution to -4°C, add 1% (g / ml) diatomaceous earth as a filter aid, press The filter is pressurized and filtered, and the filtered clear liquid is put into another reaction tank. When the filtration is completed, the filter press is dried with compressed air, the filter press is opened, and the components I+II+III are collected for precipitation.

[0014] B. Precipitation and separation of component I+III from component I+II+III: Dissolve the precipitation of component I+II+III in 4 times the amount of water for injection pre-cooled at 0°C, stir for more than 3 hours, and cool the reaction solution to a temperature of 0°C ...

Embodiment 2

[0021] A. Separation of fraction I+II+III precipitation from plasma: 1000L of frozen plasma was thawed at 32°C, the plasma temperature was adjusted to 2°C, and the pH value of the plasma was adjusted to 6.0 with acetate buffer with a pH value of 4.0 , add 95% ethanol to make the final ethanol concentration in the plasma 21%, adjust the temperature of the reaction solution to -5°C, add 1.5% (g / ml) diatomaceous earth as a filter aid, press The filter is pressurized and filtered, and the filtered clear liquid is put into another reaction tank. When the filtration is completed, the filter press is dried with compressed air, the filter press is opened, and the components I+II+III are collected for precipitation.

[0022] B. Precipitate and separate component I+III from component I+II+III: dissolve the precipitation of component I+II+III in 5 times the amount of water for injection pre-cooled at 1°C, stir for more than 3 hours, and cool the reaction solution to a temperature of 1°C ...

Embodiment 3

[0029] A. Separation of component I+II+III precipitation from plasma: 1000L of frozen plasma was thawed at 30°C, the plasma temperature was adjusted to 4°C, and the pH value of plasma was adjusted to 6.2 with acetate buffer with pH value of 4.0 , add 95% ethanol to make the final ethanol concentration in the plasma 22%, adjust the temperature of the reaction solution to -6°C, add 2.0% (g / ml) diatomaceous earth as a filter aid, press The filter is pressurized and filtered, and the filtered clear liquid is put into another reaction tank. When the filtration is completed, the filter press is dried with compressed air, the filter press is opened, and the components I+II+III are collected for precipitation.

[0030] B. Precipitate and separate component I+III from component I+II+III: dissolve the precipitation of component I+II+III in 6 times the amount of water for injection pre-cooled at 2°C, stir for more than 3 hours, and cool the reaction solution to a temperature of 2°C and s...

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Abstract

The invention relates to a preparation method of human plasma protein, in particular a method for producing intravenous injection human immune globulin by using filter press technique for separation in combination with chromatograph for purification. The method is characterized in that a filter press is adopted as a main separation device to replace a centrifugal machine for producing intravenous injection human immune globulin, so that the temperature and other conditions for separation are easy to control, the separation speed is quick, and the safety is high without a high-speed operating device. Meanwhile, ion-exchange column chromatography is adopted to further purify the product and acquire the intravenous injection human immune globulin with the purity as high as 98.5-100%. The sum of monomer and dipolymer reaches 99-99.5%. PKA (proteinkinase A) is no more than 3IU / ml and ACA (Anti Cardiolipin Antibodies) is no more than 9%. Besides, the process is high in recovery rate, and for each ton of blood plasma, 5600-6300g of intravenous injection human immune globulin can be harvested.

Description

technical field [0001] The invention relates to a preparation method of human plasma protein, in particular to a process for producing intravenously injected human immunoglobulin by separating and purifying by a filtration method and a chromatography method. Background technique [0002] Intravenous human immunoglobulin is a non-specific immunoglobulin liquid preparation prepared from human plasma and treated with virus inactivation, in which more than 95% of the immunoglobulin is used. Sexual immunoglobulin deficiency and some autoimmune diseases. There are many separation methods for plasma proteins, such as low temperature ethanol method, salting out method and Rivanol method. For the large-scale industrial production of immunoglobulins, most foreign manufacturers use the Cohn low-temperature ethanol method or other denaturation methods, and Eastern Europe and Russia use the Rivano method and individual units in my country, but they were abolished at the end of 1996. So...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/395C07K16/06C07K1/36C07K1/34C07K1/18
Inventor 孙晓东魏舒李常禄杨金平陈凤珠于洋郭晶
Owner 哈尔滨派斯菲科生物制药有限公司
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