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Globulin pasteurization process using combined protective agent

A globulin and protective agent technology, applied in the field of human immunoglobulin inactivation, can solve problems such as difficulty in ensuring protein yield and quality at the same time, achieve the effects of reducing process troubles, simple and effective verification, and low equipment cost

Pending Publication Date: 2022-03-01
HUALAN BIOLOGICAL ENG CHONGQING
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The present invention intends to provide a globulin pasteurization process using a combined protective agent to solve the technical problem that the existing pasteurized human immunoglobulin process is difficult to ensure protein yield and quality at the same time

Method used

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  • Globulin pasteurization process using combined protective agent
  • Globulin pasteurization process using combined protective agent
  • Globulin pasteurization process using combined protective agent

Examples

Experimental program
Comparison scheme
Effect test

Embodiment

[0040] The production process of human immunoglobulin includes: combined plasma, fraction I precipitation separation, fraction II+III precipitation separation, fraction III precipitation separation, fraction II precipitation separation, fraction II precipitation dissolution and ultrafiltration, pasteurization Inactivation, purification and preparation of aliquots. This protocol mainly adds a protective agent in the pasteurization step to ensure the yield and content of the target protein.

[0041] 1. Raw plasma treatment: After the raw plasma leaves the warehouse, use 70-75vol.% ethanol solution to sterilize the surface of the plasma bag, then break the plasma bag, control the temperature to melt at 0-4°C, combine the plasma after melting, and use a centrifuge Centrifuge plasma (centrifugal force: 10000RCF), collect supernatant A. Among them, the raw plasma is the supernatant after blood centrifugation to remove cells, which contains protein, inorganic salts and water, etc., ...

experiment example 1

[0050] Experimental Example 1: Study on a single protective agent

[0051] Obtain the filtrate after the ultrafiltration of equal volume through the above-mentioned steps 1-6, and the specific operation steps are:

[0052] 1. Raw material plasma treatment: After the raw material plasma leaves the warehouse, use 75Vol.% ethanol solution to disinfect the surface of the plasma bag, then break the plasma bag, control the temperature to melt at 0°C, combine the plasma after melting, and use a centrifuge to centrifuge the plasma ( The centrifugal force is 10000RCF), and the supernatant A is collected.

[0053] 2. Precipitation and separation of component I: adjust the temperature of the supernatant A to -3.0°C, the protein concentration to 65g / L, the pH to 7.30, the conductivity to 14mS / cm, and the volume percent concentration of ethanol (pure ethanol) to 10vol. % (final concentration), reacted for 3 hours, and collected the supernatant B by pressure filtration.

[0054] 3. Precip...

experiment example 2

[0062] Experimental Example 2: Research on Protective Agent Combination

[0063] According to the method of Experimental Example 1, the filtrate after ultrafiltration of equal volume (here may be referred to as protein solution) was prepared, and the protein solution was divided into 6 parts on average, and sorbitol, glycine, and maltose were used to combine in pairs, and then adjusted with 1.0 mol / l citric acid or 0.5mol / l NaOH was used to adjust the pH to 5.0±0.05 and 7.4±0.05, and water for injection was added until the protein content was 20g / l. Pasteurization was carried out after filtering with a terminal 0.22 μm filter element. The inactivation conditions were 60±0.5°C, constant temperature for 10 hours, and cooled to room temperature after constant temperature. The inactivated product is tested, and the test results are shown in Table 2, Figure 4 , Figure 5 and Figure 6 . exist figure 1 The treatment condition of 1 is sorbitol 33wt.%+glycine 10wt.%+pH 5.0; the ...

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Abstract

The invention relates to the technical field of human immune globulin inactivation, in particular to a globulin Pasteur inactivation process using a combined protective agent, a protein solution enriched with immune globulin is prepared with plasma as a raw material, Pasteur inactivation is performed on the protein solution, the protein solution contains sorbitol with the concentration of 300-400 g / l and glycine with the final concentration of 80-120 g / l, the pH value of the protein solution is 6.0-7.5, and the protein concentration is 10-30 g / L. According to the scheme, the technical problem that an existing pasteurization human immune globulin inactivation process is difficult to guarantee the protein yield and quality at the same time can be solved. The scheme can be applied to practical operation of production and preparation of the human immune globulin, is simple and easy to implement and low in cost, and has great popularization and application values, and the protein yield can reach 95% or above.

Description

technical field [0001] The invention relates to the technical field of human immunoglobulin inactivation, in particular to a globulin pasteurization inactivation process using a combined protective agent. Background technique [0002] Pasteurization is an internationally recognized, safe and effective method for inactivating viruses and other organisms. Pasteurization is usually continuous heating of protein solutions at high temperatures for more than 10 hours , inactivate the virus. The pasteurization method only needs to control the two parameters of temperature and time, and has the advantages of easy operation, simple equipment, easy amplification and cost saving. The temperature is easy to monitor during the virus inactivation process. Pasteurization can inactivate both lipid-enveloped and non-enveloped viruses. The inactivation range is wide and easy to implement. As a traditional and mature virus inactivation method, pasteurization can be used to inactivate lipid-e...

Claims

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Application Information

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IPC IPC(8): A61L2/04
CPCA61L2/0023
Inventor 张宝献夏琦鸿滕世超梁小利刘余江
Owner HUALAN BIOLOGICAL ENG CHONGQING
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