Separation technology for human blood albumin through low-temperature ethanol two-step method

A technology of human albumin and low-temperature ethanol, applied in the field of biopharmaceuticals, can solve the problems of waste of resources, the inability of patents to effectively generate value, and the prohibition of product recycling or reprocessing, so as to reduce the use of ethanol and protect human blood. The effect of albumin product quality and elimination of recycling production problems

Pending Publication Date: 2019-10-11
发贵科技(贵州)有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] Since blood products belong to high-risk industries and product recycling or reprocessing is not allowed, the above patents cannot effectively generate value
However, on the one hand, there is a huge market gap for domestic human serum albumin products, and on the other hand, there is a large proportion (up to 20%) of protein co-precipitation in the low-temperature ethanol production process, which causes waste of resources

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] Implementation Example 1: Production of human serum albumin by low-temperature ethanol two-step process.

[0044] (1) Separation of cryoprecipitate: keep the temperature at 0.5°C at 0.5°C to 1.0°C, centrifuge at 800 rpm for 20 minutes, separate the cryoprecipitate, and use the supernatant to separate the precipitates of components I+II+III.

[0045] (2) The first step of low-temperature ethanol separation (separation of Cohn component I, component II, and component III):

[0046] The process parameters are: pH 7.0, ethanol content 23%, temperature control 2.5 ℃, protein concentration range 6.8%.

[0047] After the component precipitation is completed, diatomaceous earth is added at 5 g / L, and the component precipitation is separated by pressure filtration. The press filtrate was used to isolate the Cohn Fraction V precipitate.

[0048] (3) The process parameters of the second step separation of low temperature ethanol (separation of Cohn component V) are.

[0049] Th...

Embodiment 2

[0054] Implementation example 2: production of human serum albumin by low-temperature ethanol two-step process.

[0055] (1) Separation of cryoprecipitate: maintain the temperature at 5.0°C at 4.5°C to 6.0°C, centrifuge at 2200 rpm for 10 minutes to separate the cryoprecipitate, and the supernatant is used to separate the precipitates of components I+II+III. .

[0056] (2) The first step of low-temperature ethanol separation (separation of Cohn component I, component II, and component III):

[0057] The process parameters are: pH 7.6, ethanol content 18%, temperature control 4.5 ℃, protein concentration range 6.8%.

[0058] After the component precipitation is completed, diatomaceous earth is added at 5 g / L, and the component precipitation is separated by pressure filtration. The press filtrate was used to isolate the Cohn Fraction V precipitate.

[0059] (3) The process parameters of the second step separation of low-temperature ethanol (separation of Cohn component V prec...

Embodiment 3

[0065] Implementation Example 3: Production of human serum albumin by two-step low-temperature ethanol process (without separation of cryoprecipitate).

[0066] (1) The first step of low-temperature ethanol separation (separation of Cohn component I, component II, and component III):

[0067] The process parameters are: pH 7.6, ethanol content 18%, temperature control 4.5 ℃, protein concentration range 6.8%.

[0068] After the component precipitation is completed, diatomaceous earth is added at 5 g / L, and the component precipitation is separated by pressure filtration. The press filtrate was used to isolate the Cohn Fraction V precipitate.

[0069] (2) The process parameters for the second step separation of low-temperature ethanol (separation of Cohn component V) are .

[0070] The process parameters are: pH 3.7, ethanol content 38%, temperature control 9.5 ℃, protein concentration range: 3.6%.

[0071] After the component precipitation is completed, diatomaceous earth is ...

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Abstract

The invention relates to a separation technology for plasma protein through a low-temperature ethanol method. The two-step low-temperature ethanol separation method is adopted for separating a human blood albumin product. The technology is characterized in that the step of separating a component IV precipitate does not exist in the low-temperature ethanol separation technology for the human bloodalbumin, after components I, II and III are precipitated, the component V precipitate is directly separated, the ultrafiltration process for a human blood albumin solution is a two-step ultrafiltration technology, firstly, an ultrafiltration filtrate is reserved through ultrafiltration, macromolecule impure protein is removed through ultrafiltration, and then the human blood albumin is subjected to ultrafiltration to remove micromolecule protein, residual ethyl alcohol and possible aluminium ions. The technology has the advantages that the high yield of the human blood albumin product is fundamentally guaranteed, the possibility of repeated production or the reproduction process in the production technology of the human blood albumin is completely eliminated, and it is guaranteed that production of a blood product more effectively meets the demand of GMP for the medicine.

Description

technical field [0001] This patent belongs to the field of biopharmaceuticals, and provides a high-yield low-temperature ethanol method for the production of human serum albumin. Background technique [0002] The "Good Manufacturing Practice for Drugs" (revised in 2010) has the following two requirements for potential recycling or reprocessing in the drug production process. [0003] Article 133 The product recall shall be pre-approved, and the relevant quality risks shall be fully assessed, and whether to recall shall be decided according to the assessment conclusion. Recycling should be carried out in accordance with predetermined operating procedures, and corresponding records should be kept. The validity period of the recovered products shall be determined according to the production date of the earliest batch of products in the recovered process. [0004] Article 134 Preparation products shall not be reprocessed. Unqualified preparation intermediate products, product...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07K14/765C07K1/34C07K1/30C07K1/36
CPCC07K14/765
Inventor 石正国石正兰丁恩友
Owner 发贵科技(贵州)有限公司
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