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Preparing method for human immune globulin

A human immunoglobulin and protein technology, applied in the field of human immunoglobulin preparation, can solve the problems of long cycle, low yield and purity, and achieve the effects of shortened production cycle, high product purity and good yield

Inactive Publication Date: 2014-08-27
新疆德源生物工程有限公司
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  • Abstract
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  • Application Information

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Problems solved by technology

[0005] The present invention mainly provides a preparation method of human immunoglobulin for the above-mentioned problems of low yield, low purity and long cycle

Method used

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  • Preparing method for human immune globulin
  • Preparing method for human immune globulin

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Embodiment 1: Adopt the present invention to prepare human immunoglobulin

[0033] 1. Plasma collection: collect raw plasma with high titer, and its rabies surface antibody titer should be ≥ 8IU / ml;

[0034] 2. Separation of components: Dilute the above-mentioned raw plasma with 0.14mol / L sodium chloride solution, adjust the pH to 7.10±0.04 with acetic acid buffer solution with a pH of 4.0, cool down to 0°C and start spraying 95% of it below -15°C ethanol, so that the final ethanol concentration reaches 12% (v / v), control the temperature at -2.5±0.5°C, adjust the pH to 7.10±0.04 with acetic acid buffer, stir for 2 hours, add diatomaceous earth, and press filter to separate the above Clear liquid A, control pressure ≤ 0.1MPa during filter press;

[0035] 3. Precipitation filter press: Continue to spray 95% ethanol below -15°C into the above supernatant A to make the final ethanol concentration reach 20% (v / v), control the temperature at -5.0±0.5°C, and use pH Adjust th...

Embodiment 2

[0046] Example 2: Comparing the rabies patient immunoglobulin prepared by this process with the traditional ethanol separation preparation process, the main parameters of the obtained rabies patient immunoglobulin product:

[0047]

[0048] Therefore, the quality and yield of the product prepared by the method are better than those prepared by traditional ethanol separation.

Embodiment 3

[0049] Embodiment 3: The inactivated virus process of this preparation method is compared with the low pH hatching inactivated virus process

[0050]

[0051] Therefore, the virus inactivation method used in this process is more effective than the traditional low pH virus inactivation method.

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Abstract

The invention provides a preparing method for human immune globulin. According to the preparing method, a low-temperature ethanol extraction method and a chromatography are applied crossly to remove impure proteins in a combined mode and purify the immune globulin, the purity of the globulin product can be well improved, and an S / D inactivation method and a DV 50 nanometer film are adopted for removing viruses in a combined mode, so that the product is safer and more effective.

Description

technical field [0001] The invention relates to a preparation method of human immunoglobulin, which belongs to the field of blood products. Background technique [0002] Human plasma protein products are valuable human-derived biological drugs. Since Professor Cohn established the low-temperature ethanol separation process for industrial-scale separation of plasma proteins in the 1940s, the development of blood products, especially clinical applications, market share, product safety and production processes have undergone qualitative leaps. [0003] However, compared with developed countries, my country still has a big gap in high-tech research and development or clinical application research. Most of the production processes currently used in China are low-temperature ethanol separation method plus low pH incubation inactivation method and DV50 nano-membrane virus removal method, and double inactivation methods are used to ensure the safety of products. However, the produ...

Claims

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Application Information

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IPC IPC(8): C07K16/08C07K16/06C07K1/36C07K1/34C07K1/18C07K1/14
Inventor 吕献忠苏峰
Owner 新疆德源生物工程有限公司
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